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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12926–12950 of 27471

  • HighFDA (Devices)·Z-0109-2021·2020-10-21

    SkyVision SDS System Recalled for Intermittent Video Signal Failure

    Skytron is recalling 36 SkyVision SDS System units because intermittent signal failures can cause monitors to go blank during surgery, increasing patient risk.

    Product
    SkyVision SDS System - Video Integration Model: GC-SDS-BSCB-200 - Product Usage: is a high quality, self-contained video switching and control unit for use in the operating room.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0101-2021·2020-10-21

    Siemens ADVIA Fructosamine Test Recalled for Positive Bias

    Siemens is recalling ADVIA Chemistry Systems-Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management.

    Product
    ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement of glycated protein (fructosamine) in human serum or plasma on the ADVIA Chemistry systems Siemens Material Number (SMN): 10361941
    Category
    Medical Device
    Distribution
    7 states
  • 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
  • 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
  • HighFDA (Devices)·Z-0051-2021·2020-10-14

    Ansell Microflex Diamond Grip Examination Gloves Recalled for Barrier Integrity Verification

    Ansell Healthcare Products LLC is recalling Microflex Diamond Grip Examination Gloves because they were shipped without verification of barrier integrity.

    Product
    MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner s hand or finger to prevent contamination between patient and examiner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0064-2021·2020-10-14

    Medline Recalls Non-Sterile MTO Protection Station Plus Kits

    Medline is recalling 80 non-sterile MTO Protection Station Plus kits because they were sold to facilities without sterilization capabilities.

    Product
    Kit Model #650304917, MTO Protection Station Plus with Drape - 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
  • HighFDA (Devices)·Z-0067-2021·2020-10-14

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

    Medline is recalling 16 non-sterile left heart kits sold to accounts without sterilization capabilities. The kits require sterilization prior to use.

    Product
    Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - 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
  • HighFDA (Devices)·Z-0063-2021·2020-10-14

    Medline Recalls Non-Sterile Radiology Kits Sold Without Sterilization Capability

    Medline Industries is recalling 20 non-sterile radiology kits that were sold to accounts without the ability to sterilize them prior to use.

    Product
    Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - 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
  • HighFDA (Devices)·Z-0061-2021·2020-10-14

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

    Medline Industries is recalling 60 non-sterile Left Heart Kits sold to accounts without sterilization capabilities. The kits were distributed nationwide.

    Product
    Kit Model #65021652, MTO Left Heart Kit United Reg Health - 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
  • HighFDA (Devices)·Z-0066-2021·2020-10-14

    Medline Recalls Non-Sterile Cath Lab Kits Sold Without Sterilization Capability

    Medline Industries is recalling 32 non-sterile cath lab kits because they were sold to accounts without the capability to sterilize them prior to use.

    Product
    Kit Model #650600111, MTO Left Heart St Francis Hosp - 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