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.

Filters

Agency

Category

Minimum severity

Clear filters

12801–12825 of 40151

  • HighFDA (Devices)·Z-0734-2022·2022-03-30

    Azurion Medical Imaging System Software Defect Affects Patient Dose Control

    Philips Azurion R2.1 systems have a software defect that causes the Patient Type to change unexpectedly when starting a procedure, potentially affecting dose control settings without user notification.

    Product
    Azurion systems with software release R2.0.x
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0811-2022·2022-03-30

    Biomet Fibula Composite Locking Plate Recall Due to Sterile Barrier Packaging Defect

    Biomet is recalling TRAUMA A.L.P.S. fibula composite locking plates due to packaging that may not maintain sterile barrier integrity, posing a risk of infection if used.

    Product
    BIOMET TRAUMA A.L.P.S. FIBULA COMPOSITE LOCKING PLATE 8 HOLE, Item # 856204008. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0810-2022·2022-03-30

    BIOMET Trauma DVR CROSSLOCK implants recalled for packaging integrity

    BIOMET Trauma DVR CROSSLOCK surgical implant plates may have packaging that does not maintain sterile barrier integrity, posing a risk of infection.

    Product
    BIOMET Trauma, [Item # 13182-22-26, DVR CROSSLOCK EXTRA LONG PLATE LEFT], [Item # 1318-12-126, DVR CROSSLOCK EXTRA LONG PLATE RIGHT], [Item # 1318-12-176, DVR CROSSLOCK EXTRA EXTRA LONG PLATE RIGHT]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0812-2022·2022-03-30

    Biomet Trauma Surgical Instruments Recalled Due to Packaging Defect

    Biomet is recalling TRAUMA Drill Bits, Taps, and Guide Pins due to packaging that may not seal properly, potentially compromising sterile barrier integrity and posing a risk of surgical site infection.

    Product
    BIOMET TRAUMA Drill Bit, Tap, Guide Pin: [DVR Drill Bit, Item # 212000022, DVR 2.2MM DRILL BIT], [ALPS Drill Bit, Item # 214227160, 2.7X160MM CALIBRATED DRILL], [ALPS Drill Bit, Item # 824273100, 4.5X150MM DRILL], [ALPS Drill Bit, Item # 829029170, 2.5X140MM DRILL], [ALPS Drill…
    Category
    Medical Device
    Distribution
    28 states
  • HighFDA (Devices)·Z-0809-2022·2022-03-30

    Biomet Surgical Implant Reamer Recall: Packaging Sterile Barrier Risk

    Biomet is recalling surgical implant reamers due to packaging that may lose sterile barrier integrity, risking post-surgical infection.

    Product
    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels.…
    Category
    Medical Device
    Distribution
    28 states
  • ModerateFDA (Devices)·Z-0822-2022·2022-03-30

    Medical device products from Family Dollar stores recalled for rodent contamination risk

    Medical device products from Family Dollar stores in six Southern states are being recalled due to potential rodent activity at a distribution center. Affected items include feminine hygiene products, surgical masks, contact lens solutions, and bandages.

    Product
    Medical Device products purchased from Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee. The general categories of products, but are limited to these products, includes: feminine hygiene products, surgical masks, contact…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0824-2022·2022-03-30

    Cytocell Microscope Slides Recall: Incorrect Expiry Date on Label

    Cytocell Ltd. is recalling Cytocell 8 Square Template Slides because the outer label displays an incorrect expiration date of 2023-05 when the actual validated shelf life expires 2022-02.

    Product
    Cytocell 8 Square Template Slides (Glass)- microscope slides Reference: PCN008
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0814-2022·2022-03-30

    TCL1 Breakapart Probe May Display Unexpected Genetic Signals

    Cytocell Ltd. is recalling TCL1 Breakapart FISH probes (Lot 074612) because the diagnostic test may show unexpected signals beyond the intended chromosome target.

    Product
    TCL1 Breakapart Probe, Fluorescence in situ hybridisation (FISH) is a technique allows the visualisation of DNA sequences upon chromosome Catalog Number: LPH046-A
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-0825-2022·2022-03-30

    DigniCap Delta Scalp Cooling System instructions updated for headband use

    Dignitana updated instructions for the DigniCap Delta Scalp Cooling System to recommend headband use and warn about condensation risk in certain environmental conditions.

    Product
    DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN…
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-0719-2022·2022-03-23

    Unauthorized COVID-19 Diagnostic Test Kits Imported Without FDA Approval

    SD Biosensor's STANDARD Q COVID-19 Ag Home Test kits were illegally imported without FDA approval, clearance, or authorization. Approximately 400,000 units were distributed nationwide.

    Product
    STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0780-2022·2022-03-23

    RX CHOLANGIOGRAM KIT recalled due to sterile barrier breach

    Boston Scientific is recalling RX CHOLANGIOGRAM KIT due to a sterile barrier breach that compromises device sterility. Approximately 500 units distributed worldwide are affected.

    Product
    RX CHOLANGIOGRAM KIT Material Numbers: M00575241 M00575281 M00575321 M00575361 M00575381 M00575401 M00575441 M00575481
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2022·2022-03-23

    Boston Scientific Sphincterotome Recalled for Sterile Barrier Breach

    Boston Scientific Corporation is recalling 1,811 units of Dreamtome Cannulating Sphincterotomes worldwide because the sterile barrier is compromised, creating a potential contamination risk.

    Product
    Dreamtome Cannulating Sphincterotome-DREAMTOME 44-20MM/450CM Material Number: M00584060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0754-2022·2022-03-23

    Boston Scientific DREAMTOME Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 142 units of DREAMTOME 44-30MM/450CM medical devices distributed worldwide due to a sterile barrier breach that compromises device sterility. Affected lot numbers are 27625066 and 27805561.

    Product
    DREAMTOME 44-30MM/450CM Material Number: M00584070
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0783-2022·2022-03-23

    Traverse Rail Carrier E-System components with defective short screws

    Hill-Rom Traverse Rail Carrier E-System components contain non-conforming screws that are too short to secure the rail properly. The screws could loosen over time, causing the rail system to fall and potentially injure caregivers or patients.

    Product
    (1)Traverse Rail Carrier E-System, wide 31017XX component to Liko overhead lift, (2)Traverse Rail Carrier 31025XX component to Liko overhead lift. Intended for to make safe lifting of a patient possible. Affected Devices: 3101704 TRAV RAIL CARR E-SYST STD 3102514 TR…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0808-2022·2022-03-23

    GE CARESCAPE Central Station audio alarms may be muted with unapproved keyboard

    GE Healthcare is recalling 10,445 CARESCAPE Central Station monitoring systems. If connected to an unapproved keyboard, audio alarms may be muted, potentially preventing users from receiving critical notifications.

    Product
    GE Healthcare CARESCAPE Central Station (CSCS) V2.0x MAI700 (Integrated), REF 2082278-001, and MAS700 (Desktop, REF 2082279-001.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0779-2022·2022-03-23

    Boston Scientific JAGTOME RX Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 14 JAGTOME RX medical devices worldwide due to a sterile barrier breach that compromises the device's sterility.

    Product
    JAGTOME RX 49-30-450-035 Material Number: M00573030
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0793-2022·2022-03-23

    Adult Lumbar Puncture Drug Free Tray Recalled for Manometer Leaking

    Bard Peripheral Vascular Inc is recalling 1,260 Adult Lumbar Puncture Drug Free Trays due to manometer leaking and mating issues that could affect device function.

    Product
    ADULT LUMBAR PUNCTURE DRUG FREE TRAY 20G
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0777-2022·2022-03-23

    Boston Scientific JAGTOME RX Medical Device Recalled for Sterile Barrier Breach

    Boston Scientific is recalling 101 units of JAGTOME RX devices due to compromised sterile barriers that could allow contamination and infection. The recall affects devices distributed worldwide.

    Product
    JAGTOME RX 49-20-260-035 Material Number: M00573000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0772-2022·2022-03-23

    Medical device sterile barrier breach compromises sterility in JAGTOME RX

    Boston Scientific is recalling 98 JAGTOME RX medical devices due to a sterile barrier breach. The affected units were distributed worldwide.

    Product
    JAGTOME RX 39-30-450-025 Material Number: M00573110
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0757-2022·2022-03-23

    Boston Scientific DREAMTOME Stent Devices Recalled for Sterility Compromise

    Boston Scientific is recalling 472 DREAMTOME stent devices due to sterile barrier breach affecting product sterility. Devices were distributed worldwide including the US.

    Product
    DREAMTOME 49-30MM/260CM Material Number: M00584010
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0760-2022·2022-03-23

    Hydratome RX 44-20MM medical device recalled for sterile barrier breach

    Boston Scientific is recalling 254 units of the Hydratome RX 44-20MM medical device worldwide due to a compromised sterile barrier that may affect device sterility.

    Product
    HYDRATOME RX 44-20MM/450CM Material Number: M00583060
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0755-2022·2022-03-23

    Boston Scientific DREAMTOME medical devices recalled for sterile barrier breach

    Boston Scientific is recalling 982 units of DREAMTOME medical devices due to sterile barrier breach that compromises device sterility. Affected units were distributed worldwide.

    Product
    DREAMTOME 49-20MM/260CM Material Number: M00584000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0792-2022·2022-03-23

    FDA Recalls Adult Lumbar Puncture Trays for Manometer and Connector Defects

    Bard Peripheral Vascular is recalling 116,770 adult lumbar puncture trays due to manometer leaks and connector mating defects that could affect procedure performance.

    Product
    LUMBAR PUNCTURE TRAY ADULT 20G X 3.5 DP
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2022·2022-03-23

    Boston Scientific Sphincterotome Device Recalled Due to Sterile Barrier Breach

    Boston Scientific is recalling 21,309 units of the Dreamtome RX Cannulating Sphincterotome due to a sterile barrier breach that compromises device sterility, creating a potential infection risk to patients.

    Product
    Dreamtome RX Cannulating Sphincterotome-DREAMTOME 44-20MM/260CM Material Number: M00584040
    Category
    Medical Device
    Distribution
    Distributed nationwide