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 deaths or serious injuries are reported, 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

11201–11225 of 13717

  • HighFDA (Devices)·Z-1613-2022·2022-08-31

    McKesson GYNECATH H/S Catheter Recalled Due to Temperature Excursions Prior to Delivery

    McKesson recalls gynecological catheters that may have been exposed to temperatures higher than intended during storage, potentially affecting product effectiveness. Affected units were received between June and September 2021.

    Product
    Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1565-2022·2022-08-31

    Dental Implant Recall: Nobel Biocare Device Burr Aspiration Risk

    Nobel Biocare is recalling 347 N1 TiUltra TCC dental implants due to a burr that may pose an aspiration risk during surgical implantation. No injuries have been reported.

    Product
    Nobel Biocare N1 TiUltra TCC NP 3.5x13mm
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2022·2022-08-31

    Boston Scientific Guide Catheter Distributed With Wrong Tip Curve

    Boston Scientific recalled 184 guide catheters manufactured with the wrong tip curve specification. Affected devices were distributed to Greece, France, Germany, Italy, Brazil, South Korea, and Russia, but not the U.S.

    Product
    Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1617-2022·2022-08-31

    BD Vacutainer Urine Collection Tubes Recalled for Temperature Exposure

    Mckesson Medical-Surgical is recalling BD Vacutainer urine collection tubes and kits due to facility temperature excursions from June to August 2021 that may have compromised preservative effectiveness. All lots distributed between June 1 and September 30, 2021 are affected.

    Product
    a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE, URINE COLL PLAS 4ML (100/BX 10BX/CS), Model Number: BD 364951. b. BECTON DICKINSON BD Vacutainer C&S Transfer Straw Kit TRANSFER STRAW KIT, URINE 4ML(50/BX 4BX/CS) Model Number: BD 364953. c. BECTON DICK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1606-2022·2022-08-31

    Alere Fertility Test Pregnancy Test Kits Recalled Due to Temperature Damage

    Alere Fertility Test pregnancy test kits distributed in the US have been recalled because temperature excursions during storage may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy Test Urine Sample 30 Tests, Model Number: 92210. b. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere hCG Dipstick Fertility Test hCG Pregnancy Test Urine Sample 50 Tests Model Num
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1588-2022·2022-08-31

    Drug screening tablets affected by temperature exposure during storage

    McKesson is recalling Alere Toxicology drug screening tablets due to temperature excursions during facility storage that may have reduced product effectiveness. Affected units were received between June and September 2021.

    Product
    Alere Toxicology TABLET, INSTANT BLUING F/DRUGSCREEN Model Number: 7875
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1583-2022·2022-08-31

    McKesson blood coagulation test kits recalled for temperature storage damage

    McKesson recalls Coag-Sense blood coagulation test kits nationwide due to facility temperature excursions that may have affected test effectiveness.

    Product
    a. Rapid Test Kit Coag-Sense Professional Blood Coagulation Test Prothrombin Time Test (PT/INR) Whole Blood Sample 50 Tests-IVD. Part No. 0356-50. b. Coagulation Control Kit Coag-Sense PT / INR Test (Prothrombin Time Test) Low Level / High Level 10 Strips Part No. 03P69-10
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2022·2022-08-31

    Ultrasound Probe Disinfectant Recalled: Temperature Exposure May Affect Effectiveness

    Nanosonics Sonex-HL ultrasound probe disinfectant is recalled due to temperature excursions during storage that may have affected product effectiveness.

    Product
    NANOSONICS LTD Sonex-HL Ultrasound Probe Disinfectant trophon Sonex-HL 80 mL Bottle For Trophon EPR Disinfection System Model Number: N00037
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1601-2022·2022-08-31

    McKesson Colorectal Cancer Screening Tests Recalled Due to Temperature Exposure

    McKesson Medical-Surgical is recalling MMS - IMMUNOSTICS INC colorectal cancer screening test kits due to facility temperature excursions that may have reduced product effectiveness. The recall affects lots distributed between June and September 2021.

    Product
    a. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit Consult Colorectal Cancer Screening Fecal Occult Blood Test (iFOB or FIT) Stool Sample 25 Tests, Model Number: 4487. b. MMS - IMMUNOSTICS INC McKesson Rapid Test Kit McKesson Consult Colorectal Cancer Screening Fecal Occult Blo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1570-2022·2022-08-31

    FDA Recalls Exacta-Mix 2400 Compounding System for Potential Valve Leaks

    Baxter Healthcare is recalling the Exacta-Mix 2400 compounding system due to potential leaking valves on ports 1-4 in certain lots. Affected units have lot numbers 60316024 and higher.

    Product
    The Exacta-Mix 2400 compounding system, manufactured by Baxter Healthcare Corporation, is a compounding device used in the pharmacy to compound multiple source ingredients into one final solution. This device is not intended for direct patient hook-up.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1592-2022·2022-08-31

    B. Braun Gravity Mixing Container Recalled for Temperature Exposure

    B. Braun EVA Gravity Mixing Container 1000 mL units may have been exposed to higher temperatures during storage prior to delivery, potentially affecting product effectiveness. Units distributed nationwide between June and September 2021 are affected.

    Product
    B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps recalled for packaging sterility concerns

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps due to potential packaging failures that could compromise the sterile barrier on 10,140 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2022·2022-08-31

    NUCLISENS easyMAG Magnetic Silica Reagent Kit Contamination Recall

    bioMerieux recalls NUCLISENS easyMAG Magnetic Silica reagent kits due to contamination that may cause test failures or delayed results. Affected kits were distributed across 23 U.S. states.

    Product
    NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-1586-2022·2022-08-31

    ABX PENTRA Creatinine Reagent Recalled Due to Temperature Excursion Exposure

    Mckesson Medical-Surgical is recalling ABX PENTRA Creatinine reagent due to facility temperature excursions (June-August 2021) that may have impacted product effectiveness. Affected lots were received nationwide between June 1 and September 30, 2021.

    Product
    a. ABX PENTRA CREATININE 120CP JAFFE 120/130. Ref: A11A01933. b. Reagent General Chemistry Creatinine Model Number: 1220001933
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1566-2022·2022-08-31

    GE Medical Imaging Software: Inaccurate Measurements in Global Stack Viewport

    GE Centricity and Universal Viewer software may produce inaccurate distance and area measurements in the Global Stack viewport. The FDA issued a Class II recall affecting 1,690 devices.

    Product
    (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1581-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter is recalling DISCPAC Syringe Tip Caps due to potential packaging defect that may not maintain sterile barrier. The recall affects 8,500 units distributed worldwide.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, REF H938677100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2022·2022-08-31

    Baxter DISCPAC Syringe Tip Caps recalled due to sterile barrier failure

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because packaging may not maintain a sterile barrier. Affected units were distributed worldwide including the US, Australia, Finland, Germany, Spain, and the UK.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 pack REF H938693025, b) 100 pack REF H938673100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2022·2022-08-31

    Alcon Contact Lens Solutions Recalled for Temperature Exposure During Storage and Transit

    Multiple Alcon contact lens solutions were recalled due to facility temperature excursions during storage and transit that may have reduced product effectiveness. Affected products include Clear Care and Opti Free Replenish solutions distributed nationwide between June and September 2021.

    Product
    a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1632-2022·2022-08-31

    Morrison Medical OB Kit Recalled Due to Temperature Excursion During Storage

    Mckesson is recalling Morrison Medical OB Kits because facility temperature excursions may have reduced product effectiveness. All lots received between June 1 and September 30, 2021 are affected.

    Product
    MORRISON MEDICAL Morrison Medical OB KIT, HARD PK SEALED W/CARDBOARD BX MORMED Catalog #0967NL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1580-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled Due to Sterile Packaging Barrier Risk

    Baxter Healthcare is recalling DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier. The product was distributed nationwide and internationally.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, REF H938676100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2022·2022-08-31

    Baxter Syringe Tip Caps Recalled for Potential Sterile Barrier Failure

    Baxter Healthcare Corporation is recalling 168,390 units of DISCPAC Syringe Tip Caps because the packaging may not maintain a sterile barrier, creating a contamination risk.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack, REF H93869025, b) 100 pack, REF H938674100, c) 100 pack, REF H93869100
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1621-2022·2022-08-31

    Medical Sponges Recalled for Temperature Exposure During Storage

    Mckesson Medical-Surgical is recalling MetriSponge cleaning sponges due to facility temperature excursions that may have compromised product effectiveness during storage and delivery between June and August 2021.

    Product
    METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2022·2022-08-31

    Cadwell Disposable Ground Electrodes Recalled Due to Temperature Exposure

    Cadwell Disposable Ground Electrodes may have reduced effectiveness due to facility temperature excursions between June and August 2021. All units distributed nationwide received between June 1 and September 30, 2021 are affected.

    Product
    Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions, Disposable Model Number: 302288-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1626-2022·2022-08-31

    LASIK Irrigation Cannula Recalled for Potential Temperature Exposure Damage

    Beaver-Visitec medical irrigation cannulas used in LASIK eye surgery are being recalled due to storage temperature excursions. Units distributed from June through September 2021 may have reduced effectiveness.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS Catalog #585278
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1625-2022·2022-08-31

    Surgical ophthalmic wicks recalled for potential effectiveness loss

    McKesson Medical-Surgical Inc. is recalling Beaver-Visitec Ultracell surgical wicks due to facility temperature excursions during storage. Temperature exposure may have impacted product effectiveness, affecting units distributed nationwide between June and September 2021.

    Product
    BEAVER-VISITEC INTERNATIONAL, INC. Ultracell WICK, FENSTD PED 7MMX20MM(10/BX) BVRVIS Catalog #30316-C
    Category
    Medical Device
    Distribution
    Distributed nationwide