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 deaths or serious injuries are reported, 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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4676–4700 of 13543

  • 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-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-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 (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 (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-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
  • 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-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-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-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-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-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-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
    0 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 (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 (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-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-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-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 (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 (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
    0 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