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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Minimum severity

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

Clear filters

11876–11900 of 40095

  • ModerateFDA (Devices)·Z-1729-2022·2022-09-21

    GXL Acetabular Liners Recalled Due to Non-Conforming Packaging

    Exactech is recalling certain GXL acetabular liners packaged in non-conforming bags that may cause accelerated wear of the hip implant component. No injuries have been reported.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION GXL LINER, NEUTRAL, 28MM ID, GROUP 1 CUPS, REF 130-28-51 b. NOVATION GXL LINER, NEUTRAL, 32MM ID, GROUP 2 CUPS, REF 130-32-52 c. NOVATION GXL LINER, NEUTRAL, 36MM ID, GROUP 3 CUPS…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1733-2022·2022-09-21

    GXL Hip Implant Liners Recalled for Packaging Defect Risk

    Exactech is recalling specific GXL acetabular polyethylene hip implant liners because non-conforming packaging may cause accelerated wear. The company has distributed 4,956 affected devices worldwide.

    Product
    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 42, REF 106-22-42; b. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED 22MM SZ 44, REF 106-22-44; c. ALL POLYETHYLENE ACETABULAR CUP, CEMENTED…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1735-2022·2022-09-21

    Stryker USB Converter in Mako Robotic Surgery System May Fail

    Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.

    Product
    Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
    Category
    Medical Device
    Distribution
    2 states
  • ModerateFDA (Devices)·Z-1741-2022·2022-09-21

    PTS Panels CHOL+GLU Test Strips Recalled for Incorrect Instructions

    PTS Panels CHOL+GLU Test Strips (lot A202) are recalled because incorrect instructions for use were packaged with the product. Distribution includes the US, Japan, and Russia.

    Product
    PTS Panels CHOL+GLU Test Strips (REF 1765)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1740-2022·2022-09-21

    Helix Elite SARS-CoV-2 Reference Standard Recalled for Unregistered UK Distribution

    Microbiologics Inc. has recalled Helix Elite Inactivated SARS-CoV-2 reference standards distributed to the United Kingdom because the product was not registered for use in that region.

    Product
    Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Whole Virus, REF HE0073N
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1655-2022·2022-09-14

    Philips BiPAP A40 Respiratory Devices Recalled for Motor Assembly Off-Gassing

    Philips is recalling BiPAP A40 respiratory support devices because motor assemblies were manufactured with nonconforming plastic that off-gases volatile organic compounds (VOCs). Approximately 1,414 units have been distributed domestically and internationally.

    Product
    Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1654-2022·2022-09-14

    Philips BiPAP A30 respiratory device motor assemblies recalled for VOC off-gassing

    Philips Respironics recalls Philips BiPAP A30 respiratory devices due to motor assemblies with nonconforming plastic that off-gases volatile organic compounds (VOCs). Patients should contact the manufacturer immediately.

    Product
    Philips BiPAP A30, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1656-2022·2022-09-14

    Philips BiPAP V30 Auto Respirators Recalled for VOC Off-Gassing Risk

    Philips Respironics recalls 295 BiPAP V30 Auto respiratory devices due to motor assemblies with nonconforming plastic. These assemblies off-gas volatile organic compounds (VOCs) during device operation.

    Product
    Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1659-2022·2022-09-14

    Philips OmniLab ventilator recalled for motor assembly plastic off-gassing defect

    Philips Respironics is recalling OmniLab Advanced + ventilators due to motor assemblies manufactured with nonconforming plastic that releases volatile organic compounds (VOCs). The 8 affected units were distributed across the US and internationally.

    Product
    Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1657-2022·2022-09-14

    Philips OmniLab Advanced+ sleep apnea devices recalled for off-gassing

    Philips Respironics is recalling 85 units of the OmniLab Advanced+ ventilation device due to motor assemblies containing nonconforming plastic that off-gasses volatile organic compounds.

    Product
    Philips OmniLab Advanced+, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • SevereFDA (Devices)·Z-1658-2022·2022-09-14

    Philips OmniLab Advanced+ Ventilation Devices Recalled for Plastic Off-Gassing

    Philips Respironics is recalling certain Philips OmniLab Advanced+ noninvasive ventilation devices due to motor assemblies with nonconforming plastic that can off-gas volatile organic compounds (VOCs). This is an FDA Class I recall.

    Product
    Philips OmniLab Advanced+ Intl (Flow Gen), Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
    Category
    Medical Device
    Distribution
    42 states
  • HighFDA (Devices)·Z-1682-2022·2022-09-14

    ChemoLock Chemotherapy Port Connectors Recalled for Disconnection Risk

    ICU Medical recalls ChemoLock and ChemosafeLock port connectors used in chemotherapy delivery systems due to spring defects that may prevent proper connection or cause unintended disconnection, potentially delaying treatment or exposing patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-80S; ChemoLock Bag Spike/CL-10; ChemoLock w/Mini Bag Spike/CL-17; 8 IN (20cm) APPX 1.0ml, EXT SET, MicroClave Clear, ChemoLock PORT, YCONN/CL3950; 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1679-2022·2022-09-14

    Abbott Alinity m SARS-CoV-2 Control Kit Recalled for Failed Internal Control

    Abbott is recalling 579 kits of its Alinity m SARS-CoV-2 CTRL control kit after reports of failed internal control errors preventing verification of test accuracy.

    Product
    Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1681-2022·2022-09-14

    ChemoLock Infusion Ports Recalled for Unintended Disconnection Risk

    ICU Medical recalls ChemoLock chemotherapy infusion ports for potential unintended disconnection due to spring variation, which may delay therapy and expose patients to caustic substances.

    Product
    Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX 1.5ml,ChemoLock BAG SPIKE WITH ADDITIVE PORT/CL-13; ChemoLock Port/CL2100; ChemoLock Port, 5 Units/CL2100-5; ChemoLock Port/CL2100T; Clave Bag…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1692-2022·2022-09-14

    PICC and Central Line Packs Exposed to Unvalidated Sterilization Cycles

    American Contract Systems is recalling PICC line and central line packs due to exposure to multiple sterilization cycles without validation. Two units were distributed to healthcare facilities in 13 U.S. states.

    Product
    Various PICC Line, Central Line Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1693-2022·2022-09-14

    ENT Surgical Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems recalls various ENT surgical packs that may not have been properly sterilized due to multiple sterilization cycles without adequate validation. The packs were distributed to healthcare facilities in 13 states.

    Product
    Various ENT Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1700-2022·2022-09-14

    Neurology Surgical Packs Recalled for Sterilization Validation Failure

    American Contract Systems recalls 37 units of neurology surgical packs distributed across 13 US states due to exposure to multiple sterilization cycles without proper validation.

    Product
    Various neurology packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1689-2022·2022-09-14

    Angiography Packs Recalled Due to Sterilization Validation Failure

    American Contract Systems, Inc. is recalling 57 angiography packs and trays that were exposed to multiple sterilization cycles without proper validation for repeated sterilization exposure.

    Product
    Various Angiography packs/trays
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1705-2022·2022-09-14

    Eye Surgery Packs Recalled Due to Improper Sterilization Validation

    American Contract Systems is recalling various eye and cataract surgery packs distributed to US health systems because the products were exposed to multiple sterilization cycles without validation. Unvalidated sterilization may compromise device sterility.

    Product
    Various eye packs, cataract packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1704-2022·2022-09-14

    D&C Pack Recall Due to Sterilization Validation Failure

    American Contract Systems is recalling D&C packs that were exposed to multiple sterilization cycles without proper validation. The sterilization failure may compromise device sterility.

    Product
    D&C pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1703-2022·2022-09-14

    C-Section Surgical Packs recalled for improper sterilization validation

    American Contract Systems recalls C-section surgical packs that were exposed to multiple sterilization cycles without validation. The sterilization integrity of the 24 affected units cannot be assured.

    Product
    Various C-section packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1696-2022·2022-09-14

    Port Insertion Packs Recalled Due to Unvalidated Sterilization

    American Contract Systems is recalling Various Port Insertion Packs that were exposed to multiple sterilization cycles without proper validation. The devices may not meet sterility standards.

    Product
    Various Port Insertion Packs
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1697-2022·2022-09-14

    Breast Abdominoplasty Pack Recalled for Inadequate Sterilization Cycle Validation

    American Contract Systems, Inc. is recalling Breast Abdominoplasty Packs that were exposed to multiple sterilization cycles without validation that the process could safely maintain instrument sterility through repeated exposures.

    Product
    Breast Abdominoplasty Pack
    Category
    Medical Device
    Distribution
    13 states
  • HighFDA (Devices)·Z-1687-2022·2022-09-14

    Undersized Dilator in Balloon Catheter Insertion Kit Recalled

    Datascope Corporation is recalling certain lots of an Insertion Kit for intra-aortic balloon catheters due to undersized dilators. The defect affects 10,427 units distributed in the U.S. and internationally.

    Product
    Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
    Category
    Medical Device
    Distribution
    0 states