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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16251–16275 of 40287

  • ModerateFDA (Devices)·Z-0150-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0148-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Issues

    Smith & Nephew is recalling OSTEORAPTOR 2.3 W 1UB II BLUE absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0154-2021·2020-10-28

    Smith & Nephew Recalls OSTEORAPTOR Absorbable Suture Anchors Due to Seal Defects

    Smith & Nephew is recalling OSTEORAPTOR absorbable suture anchors because improper or incomplete packaging seals may breach the sterile barrier.

    Product
    OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 72202165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-0120-2021·2020-10-28

    Baxter SIGMA Spectrum Infusion Pump IFU Update for Cleaning Practices

    Baxter is updating the Instructions for Use for the SIGMA Spectrum Infusion Pump to clarify safety communication regarding cleaning practices.

    Product
    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6)
    Category
    Medical Device
    Distribution
    1 state
  • LowFDA (Devices)·Z-0126-2021·2020-10-28

    Invivo MR Coils Recalled for Incorrect IPX1 Water Ingress Rating Label

    Invivo Corporation is recalling 12,764 MR Coils because the labels were mistakenly printed with an IPX1 rating symbol, which indicates water ingress protection.

    Product
    MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0096-2021·2020-10-21

    Handicare SwiftHook Component Recall for Mobile and Ceiling Lifts

    Handicare AB is recalling SwiftHook components used in mobile and ceiling lifts because the carry bar may detach during use, posing a risk of injury to patients and caregivers.

    Product
    SwiftHook sold as the following: a. Individually as SwiftHook b. Included with Vega505EE mobile lifts Product Usage: The mobile lifts are intended to assist people with functional impairments in scenarios involving physical positioning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0108-2021·2020-10-21

    Siemens Artis zee and Q Systems Recalled for Collision Risk

    Siemens Medical Solutions is recalling Artis zee and Artis Q systems because a software defect may cause the equipment to collide with room fixtures or patients.

    Product
    Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0099-2021·2020-10-21

    Gentian Cystatin C Calibrator Recall for Inaccurate High Measurements

    Gentian AS is recalling Cystatin C calibrators that may measure incorrect high values, potentially leading to falsely elevated patient results.

    Product
    GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0102-2021·2020-10-21

    Siemens Atellica CH Fructosamine Test Recall for Positive Bias

    Siemens is recalling Atellica CH Fructosamine tests because results may show a positive bias, potentially leading to incorrect glucose management and hypoglycemia.

    Product
    Atellica CH 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): 11097637
    Category
    Medical Device
    Distribution
    7 states
  • HighFDA (Devices)·Z-0094-2021·2020-10-21

    Genicon Aquas PowerFlow Tube Set Recalled for Lack of FDA Clearance

    Genicon, Inc. is recalling 10,808 units of the Aquas PowerFlow Tube Set because the device design did not receive proper premarket clearance from the FDA.

    Product
    Aquas PowerFlow Tube Set - Product Usage: The device delivers sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0091-2021·2020-10-21

    Mizuho OSI Recalls Levo Arms Due to Fluid Ingress Risk

    Mizuho OSI is recalling 174 Levo Arms used in spinal surgery tables due to a potential fluid ingress issue that could cause the locking mechanism to fail.

    Product
    Levo Arm Label: LEVO ARM REF 7887-050 MIZUHO OSI Refurbished Levo Arm Label: LEVO ARM REF 7887-050R MIZUHO OSI - Product Usage: used with Mizuho OSI spinal surgery tables to provide patient head support and positioning during spinal surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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
  • 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