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.

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11176–11200 of 13717

  • HighFDA (Devices)·Z-1673-2022·2022-09-07

    Eye imaging device software defect affects surgical planning calculations

    Pentacam eye imaging devices with certain software versions have a bug that causes inaccurate surgical planning printouts for toric intraocular lens procedures.

    Product
    Pentacam AXL REF 70100, Pentacam HR REF 70900. Used to image the anterior segment of the eye.
    Category
    Medical Device
    Distribution
    36 states
  • HighFDA (Devices)·Z-1670-2022·2022-09-07

    ZOOM LATITUDE Programmer Recalled for Potential Software Communication Anomalies

    Boston Scientific recalled the ZOOM LATITUDE Programmer (Model 2868) for potential software anomalies affecting communication with certain transvenous defibrillators. No injuries have been reported. The recall involves 17,172 units distributed worldwide.

    Product
    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1648-2022·2022-09-07

    Siemens Dimension Vista CA 15-3 Diagnostic Cartridges Recalled for Measurement Bias

    Siemens Healthcare Diagnostics is recalling Dimension Vista CA 15-3 Flex reagent cartridges because the diagnostic test can produce inaccurate results, reading 26–33% lower than actual values, potentially delaying appropriate patient treatment decisions.

    Product
    Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1643-2022·2022-09-07

    Cell culture medium recalled for improper storage temperature conditions

    Oxford Immunotec is recalling 6 units of AIM-V Medium (Lot 100380) distributed in seven U.S. states due to equipment failure causing storage outside the validated 2-8°C temperature range for longer than the validated duration.

    Product
    AIM-V Medium REF AV.200/500
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-1646-2022·2022-09-07

    X-ray imaging system hardware defect may prevent operation

    Siemens is recalling certain X-ray imaging systems due to a potential hardware issue with the error detection mechanism. In rare cases, this could prevent X-ray emission until system shutdown.

    Product
    Artis pheno- Model No. 10849000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1668-2022·2022-09-07

    DeRoyal Sterile Custom Kits Recalled for Defective Connectors

    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors are being recalled because the procedure packs contained a recalled product. Approximately 1,306 kits were distributed in Ohio and Tennessee.

    Product
    DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1640-2022·2022-09-07

    bioMerieux VITEK 2 and MYLA diagnostic software recall for anomalies

    bioMerieux is recalling specific software versions of VITEK 2 and MYLA diagnostic systems due to seven reported software anomalies that may affect device use.

    Product
    VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
    Category
    Medical Device
    Distribution
    0 states
  • CriticalFDA (Devices)·Z-1522-2022·2022-08-31

    INTERA 3000 implantable pump recalled for higher-than-expected flow rate

    The FDA is recalling INTERA 3000 implantable hepatic infusion pumps due to a malfunction causing higher-than-expected medication flow rates. Patients should contact their healthcare provider.

    Product
    INTERA 3000 Hepatic Artery Infusion Pump, 30 mL, Sterile, Rx Only. implantable infusion pump.
    Category
    Medical Device
    Distribution
    13 states
  • SevereFDA (Devices)·Z-1561-2022·2022-08-31

    Diaphragm pacing system external pulse generator recalled for circuit board defect

    Synapse Biomedical is recalling the NeuRx Diaphragm Pacing System External Pulse Generator due to a circuit board defect causing performance degradation, potentially leading to cardiac complications, breathing failure, or device shutdown.

    Product
    NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
    Category
    Medical Device
    Distribution
    12 states
  • SevereFDA (Devices)·Z-1525-2022·2022-08-31

    Intensive care ventilator status board may loosen, causing water damage and malfunction

    Hamilton's HAMILTON-C6 intensive care ventilator status indicator board may become loose, allowing water or disinfectants to enter the device and cause technical faults that could force the ventilator into unsafe modes where patients breathe unassisted room air.

    Product
    HAMILTON-C6 Intensive Care Ventilator, REF: 160021
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    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-1607-2022·2022-08-31

    Chest Drain System Atrium 2100 mL recalled due to temperature exposure

    The GETINGE OCEAN Chest Drain System Atrium 2100 mL is being recalled due to facility temperature excursions from June-August 2021 that may have impacted product effectiveness. Affected units were distributed nationwide between June 1 and September 30, 2021.

    Product
    GETINGE USA SALES LLC OCEAN Chest Drain System Atrium 2100 mL Model Number: 2002-000
    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-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-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-1620-2022·2022-08-31

    Medical disinfectant recalled due to temperature exposure during storage

    McKesson is recalling CaviCide and EnviroCide disinfectants that may have been exposed to excessive temperatures during storage from June to August 2021, potentially reducing their effectiveness.

    Product
    a. METREX RESEARCH CORP CaviCide1 DISINFECTANT, CLNR CAVICIDE1 1GL (4/CS) METREX, Model Number: 13-5000. b. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE 8OZ SPRAY MX-1008 METREX Model Number: 13-1008. c. METREX RESEARCH CORP CaviCide DISINFECTANT, CAVICIDE GL MX
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1630-2022·2022-08-31

    Centurion Catheter Kits Recalled Due to Temperature Exposure

    Mckesson Medical-Surgical is recalling Centurion catheter kits that were exposed to higher temperatures during facility storage prior to delivery, which may have impacted product effectiveness. All units distributed nationwide between June 1 and September 30, 2021 are affected.

    Product
    CENTURION MEDICAL PRODUCTS, LP Centurion CATH KIT, FML W/LUBE 8FR (50/CS) CNTURN Catalog # CKF105L
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1604-2022·2022-08-31

    Central Venous Catheter Kits Recalled for Potential Temperature Damage

    McKesson Medical-Surgical is recalling Teleflex Arrow Central Venous Catheter Kits due to temperature excursions during storage and shipment. Exposure to higher temperatures may have reduced product effectiveness.

    Product
    TELEFLEX LLC Arrow Central Venous Catheter Kit 16, 18 Gauge Multi Lumen Model Number:CDC-45703-XP1A (Model Numbers # IPN035619, IPN036437, IPN922677)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-1562-2022·2022-08-31

    DeRoyal Limb Holders and Security Cuffs Buckle Webbing Strap Failure

    DeRoyal is recalling specific limb holders and security cuffs due to improperly laced webbing straps that may slide loose, potentially compromising device security.

    Product
    DeRoyal limb holders: (1) DeRoyal Limb Holder, Wrist, Fixed, Quick Release, REF M8124; (2) DeRoyal Limb Holder, Ankle, Fixed, Quick Release, REF M8125; (3) DeRoyal Security Cuffs, Wrist and Ankle, Universal, REF M8136; and (4) DeRoyal Security Cuffs, Heavy Duty Vertical Psy
    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-1608-2022·2022-08-31

    3M Grounding Safety Ring Pads Recalled Due to Temperature Exposure

    3M Grounding Safety Ring pads may have been exposed to excessive temperatures during storage, potentially compromising product effectiveness. The recall affects products distributed nationwide that were received between June and September 2021.

    Product
    3M COMPANY 3M PAD, GROUNDING SAFETY RING Model Number: 9165
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2022·2022-08-31

    Medical Device Etching Solution Recalled for Potential Temperature-Related Effectiveness Loss

    ABX Pentra Etching CP solution is recalled due to temperature excursions from June-August 2021 that may have affected product effectiveness. Affected lots were distributed June 1 - September 30, 2021.

    Product
    HORIBA ABX MEDICAL INC ABX PENTRA ETCHING CP System Fluid ABX Pentra Eching Solution CP For ABX Pentra 400 Clinical Chemistry Analyzer 25 mL. Ref: 1220001769
    Category
    Medical Device
    Distribution
    Distributed nationwide