The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

12801–12825 of 114068

  • 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…
    Category
    Medical Device
    Distribution
    1 state
  • 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 (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-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-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…
    Category
    Medical Device
    Distribution
    30 states
  • 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-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 (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-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 (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 (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 (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…
    Category
    Food
    Distribution
    30 states
  • 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-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…
    Category
    Food
    Distribution
    30 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-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 (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-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-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 (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…
    Category
    Food
    Distribution
    30 states
  • 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 (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.…
    Category
    Food
    Distribution
    30 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…
    Category
    Medical Device
    Distribution
    33 states
  • 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…
    Category
    Medical Device
    Distribution
    5 states