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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16076–16100 of 39988

  • HighFDA (Devices)·Z-0095-2021·2020-10-21

    Alcon Custom-Pak Surgical Packs Recalled for Latex Glove Degradation

    Alcon is recalling 16,971 Custom-Pak Surgical Procedure Packs containing Cardinal Health PROTEXIS Latex Micro Surgical Gloves due to a degradation defect that could cause holes or tears.

    Product
    Alcon Custom-Pak Surgical Procedure Packs containing Cardinal Health" PROTEXIS" Latex Micro Surgical Gloves - Product Usage: used by ophthalmic surgeons in a variety of ophthalmic surgeries.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0098-2021·2020-10-21

    Fresenius AquaBplus Water Purification Systems Recalled for Electrical Safety Defect

    Fresenius Medical Care is recalling 15 AquaBplus water purification systems due to incorrectly crimped connectors that could cause electrical shock.

    Product
    AquaBplus and AquaBplus B2 Water Purification System. For use with a hemodialysis system to remove organic and inorganic substances and microbial contaminants from the water used for hemodialysis or related therapies. AquaBplus 1500 - Typ USA - 3 x 208V / 60Hz -Fresenius…
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0097-2021·2020-10-21

    Biomet Recalls RingLoc Hip Cups Due to Double Sterilization

    Biomet is recalling 48 RingLoc Bi-Polar Hip System Acetabular Cups because they were gamma sterilized twice, which may compromise functionality and shelf life.

    Product
    (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar Cup, E1 Antioxidant Infused, 28 MM, 41 MM: Item No. 110010458; Lot No. 710930; UDI No. (01) 00880304568747 (17) 230614 (10) 710930 (2) RingLoc Hip system Acetabular Bi-Polar Cup: Acetabular Cup…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0092-2021·2020-10-21

    Getinge Servo-i Ventilator Recall for Short Nebulizer Connector

    Getinge is recalling 431 Servo-i Ventilators because a nebulizer connector may be shorter than specified, potentially preventing the Aeroneb Nebulizer module from installing successfully.

    Product
    Servo-i Ventilator, Part No. 6487800, UDI Code 07325710000823 - Product Usage: intended for general and critical ventilator care, and it can be used for low end to high end intensive care, in different configurations. It supports a variety of breathing modes and can be used for…
    Category
    Medical Device
    Distribution
    15 states
  • ModerateFDA (Devices)·Z-0105-2021·2020-10-21

    Cook Inc. Recalls Percutaneous Neonatal Pigtail Nephrostomy Sets

    Cook Inc. is recalling 368 Percutaneous Neonatal Pigtail Nephrostomy Sets because the indwell time is decreasing from 4 months to 4 weeks.

    Product
    Percutaneous Neonatal Pigtail Nephrostomy Set, Reference Part Number 080106, Order Number G14508. The set contains a 22 gage, 5 cm Chiba Needle; an 18 gage, 5 cm trocar needle; an .038-inch (.97 mm) diameter, 30 cm PTFE-coated stainless steel; a 5, 6, and 7 French, 10 cm…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0107-2021·2020-10-21

    Ezycare Disposable Face Masks Recalled for Mislabeling as Non-Medical

    FDA is recalling Ezycare disposable face masks because they were labeled as non-medical but distributed to customers expecting medical use.

    Product
    Ezycare Face Mask, Disposable Non Medical Face Masks - Product Usage: marketed under face mask umbrella EUA as source control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0093-2021·2020-10-21

    Biomet Shoulder Prosthesis Baseplate Packaging Error Recall

    Biomet is recalling 3 units of Comprehensive Reverse Shoulder Glenosphere Mini Baseplates due to packaging errors where components may be missing or duplicated.

    Product
    Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0106-2021·2020-10-21

    Cook Inc. Recalls Pediatric Nephrostomy Stent Sets Due to Labeling Update

    Cook Inc. is recalling 380 Pediatric Nephrostomy Stent Sets because the indwell time is decreasing from 4 months to 4 weeks. The Instructions for Use are being updated to reflect this change.

    Product
    Pediatric Nephrostomy Stent Set, Reference Part Numbers 080208-S6 and 080208-S7, Order Numbers G15034 and G15035. The set contains a radiopaque pigtail catheter and stent, retention disc with pull tie, and a 10 French, 30 cm polyvinylchloride connecting tube with one-way…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0104-2021·2020-10-21

    Roche Recalls Albumin Gen.2 Reagents Due to Cross-Contamination

    Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and invalid calibrations.

    Product
    Albumin Gen.2, Catalog 05166861190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0103-2021·2020-10-21

    Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues

    Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.

    Product
    Tina-quant Complement C4 ver.2, Catalog 05991994190
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0082-2021·2020-10-14

    Biomet OnPoint Scope Procedure Kit Recalled for Sterilization Defect

    Biomet is recalling OnPoint Scope Procedure Kits because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0085-2021·2020-10-14

    Roche BenchMark ULTRA Advanced Staining System Recalled for Electrical Fire Risk

    Roche Diagnostics is recalling BenchMark ULTRA Advanced Staining Systems due to a risk of fluid leaks causing electrical shorts, heat, and fire.

    Product
    BenchMark ULTRA Advanced Staining System (IVD)- Material Number: 05342716001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0086-2021·2020-10-14

    Roche Discovery Ultra Staining System Recalled for Electrical Short Risk

    Roche Diagnostics is recalling the DISCOVERY ULTRA Advanced Staining System due to fluid leaks that can cause electrical shorts, heat, and smoke.

    Product
    DISCOVERY ULTRA Advanced Staining System (RUO-Research Use Only) Material Number: 05987750001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0059-2021·2020-10-14

    AB ULAX 1500 Flex Heat and Moisture Exchanger Recall for Disconnection Risk

    AB ULAX is recalling 1500 Flex Heat and Moisture Exchangers because they may disconnect from the respiratory circuit, potentially causing hypoxia or death.

    Product
    1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage: Heat Moisture Exchangers (HM Es) are designed to enhance humification of ventilator-dependent and non-ventilator dependent patients in critical care, home care and anesthesia.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0055-2021·2020-10-14

    Medline Recalls Quick Release Gait Belts Due to Buckle Breakage Risk

    Medline Industries is recalling 13,500 Quick Release Gait Belts because the buckle may break due to material degradation from gamma radiation exposure.

    Product
    Quick Release Gait Belt, 60
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0081-2021·2020-10-14

    Biomet Regenerex Primary Taper Cap Recalled for Sterilization Defect

    Biomet is recalling Regenerex Primary Taper Caps because they were not properly aligned for gamma sterilization, potentially leaving them unsterilized.

    Product
    Biomet Regenerex Primary Taper Cap Item Number 141269
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0054-2021·2020-10-14

    Luminex VERIGENE Processor SP Recalled for Heater Failure

    Luminex is recalling one VERIGENE Processor SP system in Missouri due to a hybridization heater failure that may cause incorrect test results.

    Product
    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0060-2021·2020-10-14

    DJO EMPOWR Tibial Knee Punch Handle Recall Due to Retaining Pin Risk

    Encore Medical is recalling 190 units of DJO EMPOWR Tibial Knee Punch Handles because the retaining pin may fall out, potentially leaving debris in the joint space.

    Product
    DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of three appropriately sized Tibial Punch Guides to broach the tibial canal in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0068-2021·2020-10-14

    Medline Recalls Non-Sterile Left Heart Kits Sold Without Sterilization Capability

    Medline Industries is recalling 16 non-sterile Left Heart Kits sold to facilities without sterilization capabilities. The kits were intended to be sterilized prior to use.

    Product
    Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and manufactured by original…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0079-2021·2020-10-14

    Biomet 3i Recalls Misaligned BellaTek Titanium Abutments

    Biomet 3i is recalling BellaTek Titanium Abutments because the hex was misaligned by 30 degrees during manufacturing, preventing correct placement.

    Product
    CERTAIN BELLATEK TITANIUM ABUTMENT 6.0MM Reference Number: IEDAT6
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0084-2021·2020-10-14

    Biomet ARTHROSIMPLICITY KIT EU Recalled Due to Sterilization Defect

    Biomet is recalling ARTHROSIMPLICITY KIT EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0083-2021·2020-10-14

    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Recalled for Sterilization Defect

    Biomet, Inc. is recalling ONPOINT SCOPE PROCEDURE KIT-EU units because they were not properly aligned with the gamma sterilization group, resulting in improper sterilization.

    Product
    Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0062-2021·2020-10-14

    Medline Recalls Non-Sterile Vascular Surgery Kits Sold Without Sterilization Capability

    Medline Industries is recalling 80 non-sterile vascular surgery kits sold to accounts without sterilization capabilities. The kits were distributed nationwide, including in CA, CO, CT, OH, TX, and NY.

    Product
    Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Usage: NAMIC Cath Lab and Interventional Radiology (IR) Kits consist of any combination of devices from the NAMIC Fluid Management finished good product families and potentially other devices designed and…
    Category
    Medical Device
    Distribution
    Distributed nationwide