The Recall Desk

Archive

November 2024 recalls

510 recalls were announced in November 2024.

What the numbers show

Critical
11
Severe
101
High
348
Moderate
39
Low
11

Of the 510 recalls this month scored against our rubric, 2% are Critical, 20% are Severe.

Which agencies issued them

401–500 of 510

  • SevereFDA (Food)·F-0073-2025·2024-11-06

    Jack & the Green Sprouts Alfalfa Recalled for Possible Listeria Contamination

    Jack & the Green Sprouts Alfalfa sprouts (5 oz containers) are being recalled due to potential Listeria monocytogenes contamination. Affected products were distributed in Iowa, Minnesota, and Wisconsin.

    Product
    Jack & the Green Sprouts Alfalfa, Net Weight 5 oz (142g). UPC 7 63247-19891 5 Keep Refrigerated. Product of USA. Jackandthegreensprouts.com, River Falls, WI 54022. EXPANDED 10/4/2024: Product was packaged in 5 oz containers that were packed in 6 count or 12 count shippi
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-0141-2025·2024-11-06

    GE Healthcare Infant Incubator Recall: Airborne Formaldehyde Off-Gassing

    GE Healthcare Giraffe Incubator Carestation CS1 units may release airborne formaldehyde residue during initial use. Manufacturer notified customers in June 2023 to run incubators for one week to off-gas any residual formaldehyde, which can cause eye irritation.

    Product
    GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-01040417; 2) 2082844-002-01044956; 3) 2082844-002-01058424; 4) 2082844-002-01069017; 5) 2082844-002-01089666; 6) 2082844-002-01090474; 7) 2082844-002-01091269; 8) 208
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Food)·F-0127-2025·2024-11-06

    Pepperjack Cheese Burger Recalled for Potential Listeria Contamination

    Dakota Toms Pepperjack Cheese Burgers are recalled for potential Listeria monocytogenes contamination. Affected products expire between 9/1/24 and 11/28/24.

    Product
    Pepperjack Cheese Burger, Dakota Toms brand, Net Wt 5.7 oz, individual pre-packaged components in MEP packaging, UPC 737296806008
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Food)·F-0129-2025·2024-11-06

    Dakota Tom's The Gambler Sandwiches Recalled for Potential Listeria Contamination

    Dakota Tom's The Gambler sandwiches are recalled for potential Listeria monocytogenes contamination. Products were distributed to retail locations in ND, SD, WY, IA, and MN, with expiration dates September 1–November 28, 2024.

    Product
    The Gambler, Dakota Toms brand, Net Wt 7.8 oz, individual pre-packaged components in MEP packaging, UPC 737296601788
    Category
    Food
    Distribution
    5 states
  • SevereFDA (Devices)·Z-0092-2025·2024-11-06

    VasoView HemoPro Vessel Harvesting System Recalled for Silicone Component Detachment

    Maquet Cardiovascular is recalling the VasoView HemoPro Endoscopic Vessel Harvesting System due to silicone detachment from the Harvesting Tool Jaws during use. This FDA Class I recall affects 28,809 units worldwide.

    Product
    VasoView HemoPro Endoscopic Vessel Harvesting System, Product Codes VH-3000-W and VH-3500
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·F-0075-2025·2024-11-06

    Enoki Mushroom Recall Due to Listeria Monocytogenes Contamination

    Enoki mushroom packages distributed across seven states are being recalled due to Listeria monocytogenes contamination. Consumers should not consume the affected product and should return it to the point of purchase.

    Product
    (Principal Display) ENOKI MUSHROOM Champignons d'enoki Net Wt: 150g (5.3oz) in a clear plastic packaged. (Back Display) UPC 860011505600 Keep Refrigerated Garder Au Froid Distributed by: Global Fresh Marketing Commerce, CA 90040
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Food)·F-0120-2025·2024-11-06

    Shirakiku Korean Seaweed Recalled for Undeclared Sesame Allergen

    Wismettac Asian Foods recalls Shirakiku Korean Seasoned Seaweed due to incorrect product labeling that fails to disclose sesame. Affected products were distributed in CA, AZ, TX, NM, WA, NY, and NV.

    Product
    The outer package of the recalled product, Shirakiku Korean Seasoned Seaweed Korean Seaweed, is INCORRECTLY labeled as follows: (Principal Display Panel) Roasted Seaweed 10-0.91 OZ (26 G) PACKAGES (NET WT 9.1 OZ (260 G). (Back Display) ROASTED SEAWEED Organic Yaki Nori Ingredient
    Category
    Food
    Distribution
    7 states
  • SevereFDA (Devices)·Z-0208-2025·2024-11-06

    Phasitron5 breathing circuits recalled for nickel-coated spring discoloration

    Percussionaire Corporation is recalling Phasitron5 breathing circuits (P5-10, P5-HC, P5-UC-10) due to discolored fluid caused by an unintended nickel coating on the spring component reacting with medicated mist. 43,830 devices have been distributed across the U.S.

    Product
    Phasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary Percussive Ventilation, used to provide airway clearance therapy
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Food)·F-0089-2025·2024-11-06

    Ginger Chicken Broccoli Salad Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Ginger Chicken Broccoli Salad Kit V due to potential Listeria monocytogenes contamination in the cooked chicken. The product was distributed to 31 states.

    Product
    Item 404790, UPC 13454 38101, Ginger Chicken Broccoli Salad Kit V, 1/6.9625lb. Distributed by Fresh Creative Foods Vista, CA.
    Category
    Food
    Distribution
    30 states
  • SevereNHTSA·24V837000·2024-11-06

    PJ TRAILERS LD trailers recalled for incorrectly installed brake axles

    PJ TRAILERS is recalling certain 2024-2025 LD trailers because air ride suspension brake axles may be installed incorrectly. This could reduce braking ability and increase the risk of crashes.

    Product
    PJ TRAILERS — PJ TRAILERS LD
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0248-2025·2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin

    Integra LifeSciences is recalling surgical patties and strips (Model 801449) due to higher-than-expected endotoxin levels in raw materials that may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/8X6 Model/Catalog Number: 801449. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2025·2024-11-06

    Smith & Nephew Knee Prosthesis Component Packaging Error: Wrong Implant Shipped

    Smith & Nephew is recalling a knee prosthesis component after discovering some packages contained a different implant than labeled. No illnesses or injuries have been reported.

    Product
    smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur prosthesis, metallic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0277-2025·2024-11-06

    Smith & Nephew Knee Prosthesis Recalled for Wrong Size Shipped

    Smith & Nephew is recalling a knee prosthesis implant after a complaint indicated that a Size 3 LEFT component was shipped instead of the labeled Size 4 LEFT. Size mismatch poses a risk if the implant is placed without prior verification.

    Product
    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0280-2025·2024-11-06

    Surgical Screwdriver Battery Pack Recalled for Foreign Material Contamination

    Pro-Dex Inc is recalling KLS Martin battery packs for surgical drivers distributed in Florida because the sterile packaging may contain Tyvek shavings that could compromise device sterility.

    Product
    KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver 2.0 surgical driver, REF: KLS-SD-2000
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0270-2025·2024-11-06

    Laryngeal Tube Device Recalled for Unapproved Pediatric Indication

    King Systems Corp. is recalling 21,939 KING LTSD laryngeal tubes nationwide because the device was marketed for pediatric use without proper FDA regulatory clearance. The device was originally approved only for adult use.

    Product
    KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0091-2025·2024-11-06

    Asian Style Chicken Stir Fry Kit recalled for Listeria monocytogenes

    Reser's Fine Foods recalled Asian Style Chicken Stir Fry Kits distributed by Fresh Creative Foods due to Listeria monocytogenes contamination in the cooked chicken. 192 cases were distributed across 30 US states.

    Product
    Item 406740, UPC 13454 38316, Asian Style Chicken Stir Fry Kit On Premise With Trays 2/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0261-2025·2024-11-06

    Ambu VivaSight 2 DLT endotracheal tubes recalled for hyper angulation risk

    Ambu is recalling VivaSight 2 DLT endotracheal tubes due to hyper angulation of the distal end, which increases risk of intubation complications and airway injury.

    Product
    Ambu¿ VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0249-2025·2024-11-06

    Surgical patties and strips recalled for endotoxin contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials. The contamination may have resulted in out-of-specification finished products.

    Product
    SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0252-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG STRP 1X6-200 Model/Catalog Number: 801453. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0247-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801409) used in surgery due to higher-than-expected endotoxin levels detected in raw materials. No illnesses have been reported.

    Product
    SURG PAT XRAY 3X3 Model/Catalog Number: 801409. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2025·2024-11-06

    Surgical Patties and Strips Recalled for Out-of-Specification Endotoxin

    Integra LifeSciences is recalling Codman Surgical Patties and Strips (Model 801400) due to higher-than-expected endotoxin levels in raw materials that resulted in out-of-specification finished products.

    Product
    SURG PAT XRAY 1/2X1/2 Model/Catalog Number: 801400. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0228-2025·2024-11-06

    Hospital Bed Fails to Send Remote Alerts Through Nurse Call System

    Hillrom Centrella Smart+ hospital beds may fail to send remote alerts through the Rauland Responder 5 Nurse Call System, though local bed alerts still function. This could delay nursing staff notification of patient needs.

    Product
    a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001, P7900B100010, P7900B100024, P7900B100208, P7900B100273, P7900B100304, P7900B000005, P7900B100011, P7900B100025, P7900B100212, P7900B100277, P7900B100307, P7900B000010, P7900B100017, P7900B10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0253-2025·2024-11-06

    Surgical Patties and Strips Recalled for Higher-Than-Expected Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification finished products. The recall affects 2,056 units distributed worldwide.

    Product
    SURG STRP 1-1/2X6 Model/Catalog Number: 801454. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0246-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Codman Surgical Patties and Strips are being recalled due to higher-than-expected endotoxin levels in raw materials. Approximately 93,782 units were distributed worldwide for use in protecting tissue during surgery.

    Product
    SURG PAT XRAY 1X3 Model/Catalog Number: 801408. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0233-2025·2024-11-06

    Abbott Alinity m HPV test kit control failures from iron contamination

    Abbott is recalling 13,318 units of its Alinity m HPV AMP Kit due to iron leaching into the lysis solution, causing positive controls to fail and potentially producing false negative test results.

    Product
    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0230-2025·2024-11-06

    LIFEPAK 15 Monitor/Defibrillator Recalled Due to Manufacturing Tool Defect

    Physio-Control is recalling 105 LIFEPAK 15 monitor/defibrillator systems due to a manufacturing defect caused by an out-of-tolerance tool used during assembly. Affected units were distributed in Connecticut, Georgia, Massachusetts, New York, Ohio, Washington, and West Virginia.

    Product
    LIFEPAK 15 (LP15) Model/Catalog Numbers: o 97577-000101 o 99577-000046 o 99577-000055 o 99577-000061 o 99577-000076 o 99577-001250 o 99577-001255 o 99577-001256 o 99577-001368 o 99577-001955 o 99577-001956 o 99577-001957 o 99577-001958 o 99577-001962 LIFEPAK 15 int
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Drugs)·D-0028-2025·2024-11-06

    Prescription Drug Recall: Cinacalcet Tablets for N-nitroso Impurity

    Dr. Reddy's Laboratories is recalling Cinacalcet 90 mg tablets due to N-nitroso impurity exceeding FDA limits. Patients should contact their healthcare provider.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0279-2025·2024-11-06

    Blood Oximeter Calibration Error Causes Inaccurate Oxygen Readings

    The AVOXimeter 1000E blood oximeter (Serial Number 6824) has calibration values that are higher than normal, causing false oxygen level readings. This may lead to patient care mismanagement based on inaccurate data.

    Product
    AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0250-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801451) worldwide due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination.

    Product
    SURG STRP 1/2X6 Model/Catalog Number: 801451. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0071-2025·2024-11-06

    Glaser Organic Farms Salsa Recalled for Possible Glass Contamination

    Glaser Organic Farms recalls All Raw Vegan Certified Organic Salsa due to potential glass contamination. The product may pose a risk of injury to consumers.

    Product
    All Raw Vegan Certified Organic Salsa, Glaser Organic Farms, Handmade fresh from our farm to you,Net wt. 8 oz, Plastic PET Container with cover, Keep Refrigerated, UPC 832910 001514
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-0234-2025·2024-11-06

    Abbott STI and HPV Test Kits Recalled for Quality Control Failures

    Abbott is recalling Alinity m STI and HPV test kits due to iron leaching that invalidates quality control checks, potentially compromising test result reliability.

    Product
    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0092-2025·2024-11-06

    Reser's Asian Style Stir Fry Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling 420 cases of Asian Style Stir Fry meal kits containing potentially contaminated cooked chicken due to Listeria monocytogenes. Affected products were distributed across 30 states with Use By dates from September through November 2024.

    Product
    Item 406897,UPC 13454 38407, Asian Style Stir Fry Single Serve OP no Trays 1/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0235-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling CODMAN Surgical Patties and Strips due to higher-than-expected endotoxin levels in raw material that may result in out-of-specification endotoxin in finished products.

    Product
    MICR PATIE RND Model/Catalog Number: 801396. CODMAN Surgical Patties and CODMAN Surgical Strips are manufactured of COTTONOID¿ Material with x-ray detectable markers. All patties have a suture string attached for ease in performing postsurgical count verification. The surgical
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0240-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Contamination

    Integra LifeSciences recalls 33,478 units of surgical patties and strips due to higher-than-expected endotoxin levels in raw materials that may have contaminated finished products.

    Product
    SURG PAT XRAY 3/4X3/4 Model/Catalog Number: 801401. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0278-2025·2024-11-06

    Knee Prosthesis Implant Recall: Wrong Size Component Shipped

    Smith & Nephew is recalling a knee prosthesis component because packages were found to contain the wrong size implant. The size 3 left component was shipped instead of the size 4 left as labeled.

    Product
    smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0255-2025·2024-11-06

    Surgical Patties and Strips Recalled for Higher Endotoxin Levels

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801456) due to higher-than-expected endotoxin levels in raw materials. These surgical devices are used for tissue protection during surgery, including CNS procedures.

    Product
    SURG STRP 3X6 Model/Catalog Number: 801456. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0096-2025·2024-11-06

    Sprouts Chicken Street Tacos recalled due to Listeria contamination

    Sprouts Farmers Market is recalling Sprouts Chicken Street Tacos due to Listeria monocytogenes contamination. Approximately 8,206 units with sell-by dates from September 2 to November 7, 2024, were distributed across 17 states.

    Product
    Sprouts Chicken Street Taco, 6 taco, perishable item kept under refrigeration, packaged in a plastic tray with plastic lid, Net wt of 1.5lbs, UPC 205916813991. Sell by dates of 9/2/2024 to 11/7/2024.
    Category
    Food
    Distribution
    17 states
  • HighFDA (Drugs)·D-0027-2025·2024-11-06

    Cinacalcet tablets recalled for nitroso impurity above FDA limits

    Dr. Reddy's Laboratories is recalling Cinacalcet 60 mg tablets nationwide because testing detected N-nitroso impurity exceeding FDA interim limits. The recall affects 35,880 bottles.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0262-2025·2024-11-06

    Dural Graft Implants Recalled for Out-of-Specification Endotoxin Levels

    Integra LifeSciences Corp. is recalling 128 units of Duraform Dural Graft Implant (Model 80-1477US, Lot CT007694) due to endotoxin levels exceeding specifications. No adverse events have been reported.

    Product
    Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0245-2025·2024-11-06

    Codman Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences has recalled Codman Surgical Patties and Strips (Model 801407) due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification endotoxin in finished products used in brain surgery.

    Product
    SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0087-2025·2024-11-06

    Premium Street Taco Kit Meal Recalled for Listeria Monocytogenes

    Reser's Fine Foods is recalling Premium Street Taco Kits due to Listeria monocytogenes contamination in the cooked chicken. Approximately 4,100 cases were distributed across 30 states.

    Product
    Item 404700, UPC 13454 38075, Premium Street Taco Kit With Trays, 2/4.9875 lbs. Distributed by Fresh Creative Foods Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0236-2025·2024-11-06

    Codman Surgical Patties Recalled for Endotoxin Contamination

    Integra LifeSciences Corp. is recalling Codman Surgical Patties and Strips due to endotoxin contamination in raw material that may result in out-of-spec finished products. The devices protect tissue during surgery, including the brain.

    Product
    SURG PAT XRAY 1/4X1-1/2 Model/Catalog Number: 801397. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0265-2025·2024-11-06

    Thyroglobulin Antibody Assay Instructions Incorrectly State Biotin Interference Resolution

    Beckman Coulter is recalling over 465,000 thyroglobulin antibody test kits because their instructions incorrectly state that biotin interference was addressed. The false information could lead to false-low test results.

    Product
    Access Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF B14994, B63978, and A38168. The Access Thyroglobulin Antibody II (TgAb) assay is used for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Ac
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0095-2025·2024-11-06

    HMS Hatch Chicken Enchilada Kits recalled for Listeria contamination

    Meal kits containing cooked chicken have been recalled due to Listeria monocytogenes contamination. The affected product was distributed across 30 U.S. states.

    Product
    Item 404866, UPC 13454 38152, HMS Hatch Chicken Enchilada Kit 1/22.225 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0243-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences' surgical patties and strips (Model 801404) are being recalled due to higher-than-expected endotoxin levels that may have resulted in out-of-specification products. No illnesses have been reported.

    Product
    SURG PAT XRAY 1/2X1-1/2 Model/Catalog Number: 801404. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0251-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences is recalling surgical patties and strips (Model 801452) due to higher-than-expected endotoxin levels in raw materials that may result in out-of-specification contamination. Approximately 4,818 units are affected.

    Product
    SURG STRP 3/4X6 Model/Catalog Number: 801452. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0085-2025·2024-11-06

    Reser's Chicken Street Taco Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Chicken Street Taco Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The product was distributed across 32 states.

    Product
    Item 404710, UPC 13454 38080, Chicken Street Taco Kit with Trays, 4.985 lb. Item 13454 38080 Chicken Street Taco Kit with Trays, 2/4.985 lb. bags per case. Distributed by Fresh Creative Foods, Vista, CA or Reser's Fine Foods, Inc. Beaverton, OR.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0268-2025·2024-11-06

    Nihon Kohden Adult Ear Clip SpO2 Sensors Recalled for Lack of FDA Clearance

    Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.

    Product
    Nihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear Clip, each
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0140-2025·2024-11-06

    GE Healthcare Giraffe infant incubator recalled for formaldehyde exposure

    GE Healthcare Giraffe Omnibed infant incubators may release airborne formaldehyde when newly manufactured. Customers were notified in June 2023 to run units for one week to reduce potential off-gassing.

    Product
    GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers: 1) 2082844-001-01040418; 2) 2082844-001-01046784; 3) 2082844-001-01052324; 4) 2082844-001-01052572; 5) 2082844-001-01055337; 6) 2082844-001-01065693; 7) 2
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0275-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Uncleared Pediatric Indication

    King Systems is recalling the King LTSD Size 2 oropharyngeal airway because it was distributed with a pediatric indication that lacks proper FDA 510(k) clearance, exceeding exemption limits.

    Product
    KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0093-2025·2024-11-06

    Home Chef Chicken Street Taco Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Home Chef Chicken Street Taco Kits due to Listeria monocytogenes contamination in the cooked chicken. The kits were distributed across 32 states with use-by dates from September through November 2024.

    Product
    Item 406581, UPC 40134 30435, Home Chef Kit Street Taco Chicken With Tray, 2/4.985 LB. Distributed by Fresh Creative Foods, Vista, CA or by Reser's Fine Foods Inc. Beaverton, OR. Item 406581, UPC 40134 30435, Home Chef Chicken Street Taco Kit With Trays, 2/4.985 LB. Distributed
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0078-2025·2024-11-06

    Bistro 28 Chicken Enchilada Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Bistro 28 Creamy Green Chile Chicken Enchilada Meal Kits due to Listeria monocytogenes contamination in the cooked chicken. The affected meal kits were distributed across 30 U.S. states.

    Product
    Item 407118, UPC 13454 38493, Bistro 28 Creamy Green Chile Chicken Enchilada Express Meal Kit. Make 6 Enchiladas. Ready in 5 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384937, Case UPC 13454 38493, Bistro 28 Creamy Gre
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0072-2025·2024-11-06

    New Horizen BBQ Chicken Sandwich Recalled for Listeria Contamination

    Whitsons Food Service recalls 1,152 units of New Horizen Gourmet BBQ Pulled Chicken Sandwiches distributed in New York due to potential Listeria monocytogenes contamination.

    Product
    New Horizen Gourmet BBQ Pulled Chicken Sandwich on Everything Bialy; KEEP FROZEN; COOK & SERVE; Cooking Instructions: Conventional oven (Preheat oven to 350oF). Thaw product overnight. Cook meal for 20 mins or until an internal temp of 165oF. For quality purposes only, cook produ
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0080-2025·2024-11-06

    Bistro 28 Chicken Burrito Bowl Express Meal Kit recalled for Listeria

    Reser's Fine Foods is recalling Bistro 28 Chicken Burrito Bowl Express Meal Kits distributed across 31 states due to Listeria monocytogenes contamination in the cooked chicken. No illnesses have been reported.

    Product
    Item 407119, UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. Ready in 5 MIN. Net wt. 25 oz (1 LB 9 OZ) 788g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384944, Case UPC 13454 38494, Bistro 28 Chicken Burrito Bowl Express Meal Kit. 4/25oz.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0242-2025·2024-11-06

    Integra Recalls Surgical Patties and Strips Due to Endotoxin Levels

    Integra LifeSciences is recalling Codman Surgical Patties and Strips because raw material contained higher-than-expected endotoxin levels, potentially affecting finished goods.

    Product
    SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0232-2025·2024-11-06

    Olympus Quest Spectrum 3 Fluorescent Imaging System Recalled for EMC Defect

    Olympus is recalling three Quest Spectrum 3 Fluorescent Imaging Systems in Ohio because they do not meet electromagnetic compatibility standards, which could cause malfunction during procedures.

    Product
    Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029, ART-SYS-0030 The Quest Spectrum3 is a fluorescent imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow for the evaluation of tissue perfusion, a
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0274-2025·2024-11-06

    FDA Recalls Pediatric Oropharyngeal Airway Kit for Regulatory Non-Compliance

    King Systems Corp. is recalling 21,591 KING LTSD airway kits nationwide. The devices were distributed with an unauthorized indication for pediatric use that exceeds FDA regulatory authorization.

    Product
    KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0082-2025·2024-11-06

    Don Pancho Enchilada Meal Kit Recalled for Listeria Contamination

    Reser's Fine Foods recalls Don Pancho Creamy Green Chile Chicken Enchilada Express Meal Kits due to potential Listeria monocytogenes contamination in the cooked chicken. The recall affects 4,179 cases distributed across 30 states.

    Product
    Item 404856, UPC 71117 12506, Don Pancho Creamy Green Chile Chicken Enchilada Express Meal Kit. Made 6 Enchiladas . Ready in 4 MIN. Net wt. 27 oz (1 LB 11 OZ) 765g. There are 6 packages per case. Distributed by Reser's Fine Foods Inc. Beaverton, OR. www.DONPANCHO.COM.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0237-2025·2024-11-06

    Surgical Patties and Strips Recalled for Endotoxin Contamination

    Integra LifeSciences is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw materials used during manufacturing. The affected devices were distributed worldwide to healthcare facilities.

    Product
    SURG PAT XRAY 1/4X3 Model/Catalog Number: 801398. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0029-2025·2024-11-06

    OTC Antihistamine Recalled for Stability Failure and Superpotent Concentration

    BLI International is recalling Chlorpheniramine Maleate 4 mg tablets because the product failed stability testing, showing increased potency beyond specified limits. The recall affects 4,901 cases distributed to customers in Ohio and Missouri.

    Product
    CHLORPHENIRAMINE MALEATE 4MG — CHLORPHENIRAMINE MALEATE 4MG (CHLORPHENIRAMINE MALEATE 4MG)
    Category
    Drug
    Distribution
    2 states
  • HighFDA (Drugs)·D-0030-2025·2024-11-06

    Accord Healthcare Recalls Cinacalcet Tablets Due to Nitrosamine Contamination

    Accord Healthcare is recalling Cinacalcet 30mg tablets nationwide due to a nitrosamine impurity (N-nitroso-cinacalcet) exceeding acceptable daily intake limits. Patients should consult their healthcare provider to confirm if their medication is affected.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0083-2025·2024-11-06

    Don Pancho Chicken Quesadilla Meal Kits Recalled for Listeria Monocytogenes

    Reser's Fine Foods is recalling Don Pancho Chicken Quesadilla Express Meal Kits due to potential Listeria monocytogenes contamination in the cooked chicken component. No illnesses have been reported.

    Product
    Item 404852, UPC 71117 12507, Don Pancho Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Case GTIN 10071117125075, Case UPC 7111712507, Don Pancho Chicken Quesadilla Express Meal Kit. 6/22.5oz bags. Distributed by Re
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0079-2025·2024-11-06

    Reser's Chicken Quesadilla Meal Kit Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Bistro 28 Chicken Quesadilla Express Meal Kits distributed across 30 states due to potential Listeria monocytogenes contamination in the cooked chicken.

    Product
    Item 407121, UPC 13454 38496, Bistro 28 Chicken Quesadilla Express Meal Kit. Make 3 Quesadilla. Ready in 4 MIN. Net wt. 22.5 oz (1 LB 6.5 OZ) 638g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384968, Case UPC 13454 38496, Bistro 28 Chicken Quesadilla Expres
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0081-2025·2024-11-06

    Chicken Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods recalled Bistro 28 Chicken Street Tacos Express Meal Kits due to Listeria monocytogenes in the cooked chicken. The recall affects 2,880 cases distributed across 31 states.

    Product
    Item 407120, UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Meal Kit. Made 6 Tacos. Ready in 3 MIN. Net wt. 22 oz (1 LB 6 OZ) 624g. Distributed by Fresh Creative Foods, Vista, CA. Case GTIN 10013454384951, Case UPC 13454 38495, Bistro 28 Chicken Street Tacos Express Mea
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0266-2025·2024-11-06

    Medical Diagnostic Stain Product Recalled for Out-of-Specification Color Change

    Remel, Inc is recalling 29 kits of remel BactiDrop Acridine Orange after discovery that the solution can change color during use, resulting in out-of-specification fluorescent staining results.

    Product
    remel BactiDrop Acridine Orange, REF 21502, 50 per package.
    Category
    Medical Device
    Distribution
    8 states
  • HighFDA (Food)·F-0094-2025·2024-11-06

    Home Chef Asian Style Chicken Stir Fry Kits Recalled for Listeria Contamination

    Reser's Fine Foods is recalling Home Chef Asian Style Chicken Stir Fry meal kits due to potential Listeria monocytogenes contamination in the cooked chicken. The affected products were distributed across 30 states.

    Product
    Item 406873, UPC 40134 30852, Home Chef Asian Style Chicken Stir Fry OP With Trays 2/6.5 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Devices)·Z-0273-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Use

    King Systems' KING LTSD oropharyngeal airway was marketed for pediatric use but lacked the required FDA clearance for that indication. Approximately 17,925 units were distributed nationwide.

    Product
    KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0090-2025·2024-11-06

    Green Chile Chicken Enchilada Kit Recalled Due to Listeria Contamination

    Reser's Fine Foods is recalling Green Chile Chicken Enchilada Kits due to Listeria monocytogenes contamination in the cooked chicken. Affected products were distributed across 30 U.S. states.

    Product
    Item 404977, UPC 13454 38191, Green Chile Chicken Enchilada Kit O.P. No Trays 2/6.75 LB. Distributed by Fresh Creative Foods, Vista, CA.
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0086-2025·2024-11-06

    Reser's Don Pancho Meal Kits Recalled for Listeria Contamination

    Reser's Fine Foods recalled 16,696 cases of Don Pancho Kit OP Street Taco Chicken meal kits due to Listeria monocytogenes contamination in the cooked chicken. The kits were distributed across 30 US states.

    Product
    Item 404711, UPC 13454 38082, Don Pancho Kit OP Street Taco Chicken NO Trays, 4.985 lb. Case GTIN 10013454380823, Case UPC Code 1345438082, Don Pancho Kit OP Street Taco Chicken NO Trays. 2/4.985 lb. bags per case. Distributed by Fresh Creative Foods, Vista, CA or Reser's Fine
    Category
    Food
    Distribution
    30 states
  • HighFDA (Food)·F-0084-2025·2024-11-06

    Don Pancho Chicken Street Tacos Meal Kit Recalled for Listeria

    Reser's Fine Foods is recalling Don Pancho Chicken Street Tacos Meal Kit due to Listeria monocytogenes contamination in the cooked chicken. Approximately 7,909 cases were distributed across 30 states.

    Product
    Item 404764, UPC 71117 12500, Don Pancho Chicken Street Tacos Express Meal Kit. Made 6 Tacos. Ready in 3 MIN. Net wt. 22 oz (1 LB 6 OZ) 624g. Case GTIN 10071117125006, Case UPC 71117 12500, Don Pancho Chicken Street Tacos Express Meal Kit. Made 6 Tacos 6/22oz. bags. Distributed
    Category
    Food
    Distribution
    30 states
  • HighFDA (Drugs)·D-0032-2025·2024-11-06

    Cinacalcet 90 mg Tablets Recalled for Nitrosamine Impurity Above Safety Limits

    Accord Healthcare is recalling Cinacalcet 90 mg tablets nationwide due to nitrosamine impurity (N-nitroso-cinacalcet) at levels exceeding the FDA's acceptable daily intake limit. The issue stems from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0031-2025·2024-11-06

    Cinacalcet Tablets Recalled Due to Nitrosamine Impurity

    Accord Healthcare recalls Cinacalcet 60mg tablets nationwide because N-nitroso-cinacalcet impurity was detected above acceptable daily intake limits. The contamination resulted from manufacturing process deviations.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0264-2025·2024-11-06

    Olympus Electrosurgical Generator ESG-410 Recalled for Audio Buffer System Error

    Olympus Corporation recalls 279 units of its ESG-410 electrosurgical generator nationwide due to increased complaints of system error E1226 (Could not write to Audio Buffer) occurring during surgical procedures.

    Product
    Olympus Electrosurgical Generator, Model Number ESG-410 (SEP) Version WA91327U
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0026-2025·2024-11-06

    Cinacalcet tablets recalled for manufacturing impurity exceeding FDA limits

    Dr. Reddy's Laboratories recalls Cinacalcet 30 mg tablets nationwide due to manufacturing defects that produced N-nitroso impurity above FDA recommended limits. Patients should contact their healthcare provider if they are taking an affected lot.

    Product
    CINACALCET — CINACALCET (CINACALCET)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0244-2025·2024-11-06

    Surgical patties and strips recalled for elevated endotoxin levels in raw materials

    Integra LifeSciences has recalled Codman surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, which may result in out-of-specification endotoxin in finished products.

    Product
    SURG PAT XRAY 1/2X2 Model/Catalog Number: 801406. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0257-2025·2024-11-06

    Covidien Chameleon PTA Balloon Catheter Recalled for Failed Pressure Testing

    Covidien is recalling specific lots of its Chameleon PTA Balloon Catheter that failed in-house pressure testing. The affected catheters were distributed worldwide to the US and 18 countries.

    Product
    Chameleon PTA Balloon Catheter with Injection Port 5mm x 40mm x 75cm (CFN CH05-40-75US), 6mm x 40mm x 75cm (CFN CH06-40-75US), 7mm x 40mm x 75cm (CFN CH07-40-75US), 8mm x 40mm x 75cm (CFN CH08-40-75US), 9mm x 40mm x 75cm (CFN CH09-40-75US), 10mm x 40mm x 75cm (CFN CH10-40-75US),
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2025·2024-11-06

    Nihon Kohden SpO2 Sensor Recalled Lacking FDA Market Approval

    Nihon Kohden America is recalling its Adult/Pediatric Forehead Disposable SpO2 Sensor (Model 809030006) because the device was distributed without FDA market approval or clearance.

    Product
    Nihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp. SpO2 Forehead Probe, Adult, 10/Box
    Category
    Medical Device
    Distribution
    29 states
  • HighFDA (Devices)·Z-0269-2025·2024-11-06

    AMBU King LTSD Oropharyngeal Airway Recalled for Unauthorized Pediatric Indication

    King Systems Corp. is recalling AMBU King LTSD oropharyngeal airways because they were marketed for pediatric use without FDA clearance for that indication. The device exceeded its 510(k) exemption limitations.

    Product
    AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0259-2025·2024-11-06

    Pregnancy Test Kits Recalled for False Negative Results

    Osom Ultra hCG pregnancy test kits are recalled due to false negative results. The devices failed to detect hCG in samples with confirmed hCG presence.

    Product
    Osom Ultra hCG Combo Test- IVD immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in serum or urine for the early confirmation of pregnancy. Model/Catalog Number: 1004
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0238-2025·2024-11-06

    Surgical patties recalled due to higher-than-expected endotoxin levels

    Integra LifeSciences Corp. is recalling surgical patties and strips due to higher-than-expected endotoxin levels in raw material that may have resulted in out-of-specification finished products used during surgery.

    Product
    SURG PAT XRAY 1/4X1/4 Model/Catalog Number: 801399. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0254-2025·2024-11-06

    Surgical Patties and Strips recalled for elevated endotoxin levels

    Integra LifeSciences recalls 1,222 Surgical Patties and Strips (Model 801455) due to elevated endotoxin in raw material, which may contaminate finished products used to protect tissue during surgery.

    Product
    SURG STRP 2X6 Model/Catalog Number: 801455. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0231-2025·2024-11-06

    ClariTEE Probe Ultrasound Recall Due to Defective Epoxy Sealing

    ImaCor is recalling 73 ClariTEE Probe ultrasound units due to defective epoxy sealing that could degrade diagnostic image quality. The affected units were distributed in Florida, Georgia, New Jersey, and Tennessee.

    Product
    ClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor ultrasound diagnostic platforms. Model/Catalog Number: CLT-010, CLT-010-1
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0256-2025·2024-11-06

    Surgical Patties and Strips recalled for endotoxin contamination in raw materials

    Integra LifeSciences is recalling Surgical Patties and Strips (Model 801457) due to higher-than-expected endotoxin levels in raw materials. These surgical devices protect tissue during operations, including brain and nervous system procedures.

    Product
    SURG STRP 3-1/2X6 Model/Catalog Number:801457. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0282-2025·2024-11-06

    Smith & Nephew Knee Prosthesis Component Recalled for Incorrect Labeling

    Smith & Nephew recalled a knee prosthesis component after a complaint indicated the package contained the wrong size and type of implant instead of what was labeled. This product substitution could result in incorrect implant during surgery.

    Product
    smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur prosthesis, metallic
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0241-2025·2024-11-06

    Surgical Patties and Strips Recalled for Elevated Endotoxin Levels

    Integra LifeSciences Corp. is recalling surgical patties and strips (Model 801402) used in surgery due to higher-than-expected endotoxin levels in raw materials that may affect the finished product.

    Product
    SURG PAT XRAY 1/2X1 Model/Catalog Number: 801402. The surgical patties and surgical strips are indicated for the use in protection of tissue, including brain and other tissues of the central nervous system, during surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0229-2025·2024-11-06

    Olympus Endoscopic Flushing Pump Recalled Due to Function Loss

    Olympus is recalling the OFP-2 Endoscopic Flushing Pump due to intermittent loss of function caused by internal component connection failure. Approximately 445 units distributed nationwide are affected.

    Product
    Olympus Endoscopic Flushing Pump, Model/Catalog Number: OFP-2 (K10001141)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0263-2025·2024-11-06

    Westmed Flex Extenders recalled for connector failure risk

    Westmed is recalling Flex Extenders because connectors may fail to hold properly, potentially causing the breathing circuit to leak or disconnect and creating life-threatening conditions. Over 50,000 units are affected across multiple U.S. states.

    Product
    1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight conne
    Category
    Medical Device
    Distribution
    30 states
  • ModerateFDA (Devices)·Z-0272-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Limitation

    King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0271-2025·2024-11-06

    King LTSD Oropharyngeal Airway Recalled for Pediatric Indication Exemption

    King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.

    Product
    KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0260-2025·2024-11-06

    Surgical tracking device patient labels show incorrect expiration date

    Patient label stickers on Insight Base Flex tracking device snaps have incorrect expiration dates. The stickers show manufacturing date instead of actual expiration date, though the correct date appears on carton and pouch labels.

    Product
    Product Name: Insight Base Flex - 8, Ref 608-3TX; The device consists of a sterile Snap that includes reflective features that facilitate imaging of the (attached) instrument using instrument tracking technology when used with a compatible tracking system. Each TrackX¿ Snap has a
    Category
    Medical Device
    Distribution
    5 states
  • ModerateFDA (Food)·F-0070-2025·2024-11-06

    International Delight Peppermint Mocha Mislabeled as Zero Sugar Product Recall

    DANONE US LLC is recalling Home Alone International Delight Peppermint Mocha Zero Sugar beverages because the product is labeled as zero sugar but actually contains sugar. The recall affects 1,799 cases distributed across multiple states.

    Product
    Home Alone International Delight Peppermint Mocha Zero Sugar, 32oz plastic bottle, 6 bottles per case. Refrigerated.
    Category
    Food
    Distribution
    13 states
  • ModerateFDA (Devices)·Z-0258-2025·2024-11-06

    17-OH Progesterone ELISA Kit Recalled for Labeling Discrepancy

    DRG International is recalling 504 units of its 17-OH Progesterone ELISA kit (Model EIA-1292) due to mismatched control acceptance ranges between the Certificate of Analysis and component labels, causing test failure.

    Product
    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0283-2025·2024-11-06

    West Pharmaceutical Recalls Vial2Bag Advanced Devices Due to Sterile Barrier Risk

    West Pharmaceutical Services is recalling Vial2Bag Advanced 20mm Admixture Devices because heat exposure during shipping may have compromised the sterile barrier.

    Product
    Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixture Device Model/Catalog Number: 6070030 Software Version: Not applicable Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the rec
    Category
    Medical Device
    Distribution
    33 states
  • ModerateFDA (Devices)·Z-0276-2025·2024-11-06

    KING LTSD Oropharyngeal Airway Kit Recalled for Unapproved Pediatric Use

    King Systems Corp. is recalling KING LTSD airway kits (Model KKLTSD4325) because they were marketed for pediatric use without FDA approval for that indication. Approximately 36,727 units were distributed nationwide.

    Product
    KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V832000·2024-11-05

    2024 Tesla Cybertruck drive inverter fault may cause power loss

    Tesla is recalling 2024 Cybertruck vehicles due to a drive inverter fault that may cause loss of propulsion. Affected owners will receive a free inverter replacement.

    Product
    TESLA — TESLA CYBERTRUCK
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • SevereNHTSA·24V836000·2024-11-05

    2024-2025 Lucid Air vehicles recalled for wiring harness defect

    Lucid is recalling 2024-2025 Air models due to a rear subframe wiring harness that may be too short, causing power loss to the rear drive unit and increasing crash risk. Replacement is free.

    Product
    LUCID — LUCID AIR
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·24V647000·2024-11-05

    Nova Bus LFS Vehicles Recalled for Faulty Seat Belt Retraction

    Nova Bus is recalling certain 2010-2024 LFS buses because the driver's seat belt may not retract properly. This can result in a loose seat belt, increasing the risk of injury in a crash.

    Product
    NOVA BUS — NOVA BUS LFS, LFS ARTIC
    Category
    Vehicle
    Distribution
    Distributed nationwide

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