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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11926–11950 of 13802

  • ModerateFDA (Devices)·Z-0984-2022·2022-04-27

    Beckman Coulter IRISpec CA Control glucose measurement failures recalled

    Beckman Coulter is recalling IRISpec CA/CB/CC control kits due to failures in glucose measurement for the CA Control component. The recall affects laboratory quality control products distributed worldwide.

    Product
    Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0954-2022·2022-04-27

    Medical Device Reference Standard Recalled for Inadequate Quality Control Process

    Microbiologics Inc recalls an inactivated Mycoplasma genitalium reference standard (Lot HE0069-02-1) because its quality control process did not meet specification requirements. This reference material is used in diagnostic and laboratory testing.

    Product
    Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0968-2022·2022-04-27

    X-ray Imaging System Cooling Failure May Cause Tube Overheating

    Siemens Artis zee ceiling X-ray systems may fail to cool the X-ray tube if the coolant level drops. The system will automatically block X-ray emissions and display warning messages to prevent equipment damage.

    Product
    Artis zee ceiling, Model Number 10094137
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0948-2022·2022-04-27

    Baxter Syringe Tip Caps Recalled Due to Incorrect Labeling

    Baxter is recalling DISCPAC syringe tip caps that are mislabeled as self-righting when they do not possess this capability, risking improper use in medical procedures.

    Product
    Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0956-2022·2022-04-27

    Abbott TactiCath Ablation Catheter Disabled by Preprogrammed First-Use Date

    Abbott is recalling 2,134 TactiCath ablation catheters manufactured with a preprogrammed 'First Use Date' that disables the device. Affected devices with 37 specific lot numbers were distributed in the U.S. and 21 other countries.

    Product
    Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0949-2022·2022-04-27

    Terumo Cardiovascular Procedure Kit Recall for Shipping Damage

    Terumo Cardiovascular Systems Corp is recalling two lots of cardiovascular procedure kits due to packaging damage that occurred during shipping. The recall affects 64 units distributed in California and Indiana.

    Product
    Cardiovascular Procedure Kit catalog # 76645 & 73806
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0955-2022·2022-04-27

    Inactivated Mycoplasma genitalium reference material recalled due to inadequate QC

    Microbiologics Inc is recalling an inactivated Mycoplasma genitalium reference material (Catalog # HE0070N, Lot HE0070-01-1) because the quality control process did not meet specification requirements.

    Product
    Inactivated macrolide-resistant Mycoplasma genitalium
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0971-2022·2022-04-27

    X-Ray Imaging System Cooling Circuit Failure Recall

    Siemens is recalling Artis zee floor MN X-ray systems due to a potential cooling circuit malfunction. If coolant drops below adequate levels, the X-ray tube may not cool properly and the system will automatically shut down.

    Product
    Artis zee floor MN, Model Number 10094142
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0981-2022·2022-04-27

    Oral DNA Collection Device Recalled for Evaporating Stabilizing Liquid

    DNA Genotek Inc. is recalling ORAcollect Dx oral DNA collection devices because the stabilizing liquid can evaporate, reducing shelf life and potentially affecting sample preservation.

    Product
    ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078, OCD-100.032 and OCD-100A, OCD-100A.022, OCD-100A.023, OCD-100A.024, OCD-100A.025
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0980-2022·2022-04-27

    Artis Q.zen Biplane X-ray Systems Coolant Level Failure Recall

    Siemens is recalling 69 Artis Q.zen biplane systems where coolant levels may drop sufficiently to prevent adequate X-ray tube cooling, triggering automatic shutdown safeguards.

    Product
    Artis Q.zen biplane, Model Number 10848355
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0918-2022·2022-04-20

    Cub 2 Enclosed Bed Canopy System Recalled Due to Potential Misuse

    Sensory Medical Inc recalled 225 units of the Cub 2 Enclosed Bed Canopy System for potential misuse risk. The firm is updating product warnings and precautions for devices distributed before December 16, 2021.

    Product
    Cub 2 Enclosed Bed Canopy System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0906-2022·2022-04-20

    Integra Universal Flexible Arm Recall: Internal Cable May Break

    Integra LifeSciences is recalling the Universal Flexible Arm (part number REF 1362275) because excess tightening force can break the internal cable at the tip, rendering the device unusable.

    Product
    Integra Universal Flexible Arm part number REF 1362275
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0899-2022·2022-04-20

    iTotal Identity Knee Replacement System—incorrect tibial base plate packaged

    Conformis is recalling specific units of the iTotal Identity Posterior Stabilised Knee Replacement System due to incorrect tibial base plate implants being packaged in surgical kits.

    Product
    iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number: TPS-301-1113-020101
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0923-2022·2022-04-20

    Abbott Vascular Cardiovascular Device Recalled for Leaks and Loose Connections

    Abbott Vascular is recalling the 20/30 Priority Pack w/COPILOT device due to an increase in complaints of leaks and loose connections. The recall affects 131 lots distributed nationwide and internationally.

    Product
    20/30 Priority Pack w/COPILOT - REF 1003327 WPL2122272-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0915-2022·2022-04-20

    Boston Scientific ROTAWIRE Drive guide wire devices recalled for open pouch seals

    Boston Scientific is recalling ROTAWIRE Drive and ROTAWIRE Drive Floppy guide wire devices because pouch seals may be open, compromising sterility. The recall affects 433 5-packs distributed in the US, territories, Japan, and Canada.

    Product
    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0912-2022·2022-04-20

    Orthopedic surgical hammertoe instrument recalled for improper component sizing

    Nextremity Solutions is recalling the Nextra Hammertoe Correction System due to an oversized driver component that makes it difficult to properly connect and remove during surgery.

    Product
    Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532K Orthopedic surgical instrument
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0935-2022·2022-04-20

    ECG Electrode Set Fails Electrical Safety, May Prevent Effective Defibrillation

    Graphic Controls' CLARAVUE pediatric electrode set fails electrical safety standards. The device may not deliver adequate charge during defibrillation, potentially rendering emergency treatment ineffective.

    Product
    CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0900-2022·2022-04-20

    FDA Updates Labeling for LIPOSORBER LDL Adsorption Column Due to Anaphylactoid Shock Risk

    LIPOSORBER LA-15 LDL Adsorption Column labeling has been updated to address a risk of severe anaphylactoid reactions and shock in patients receiving treatment while taking ACE inhibitors.

    Product
    LIPOSORBER System, Model: LA-15, consisting of: Apheresis machine, product# 101445 model: MA-03, and disposables (product#, model) [#101447, KP-05 Sulflux Plasma Separator], [#101473, HDE KP-05 Sulflux Plasma Separator], [#101785, LA-15 (AU) LDL Adsorption Column (L
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0924-2022·2022-04-20

    Abbott INDEFLATOR Plus 30 Device Recalled for Leaks and Connection Faults

    Abbott Vascular is recalling INDEFLATOR Plus 30 balloon inflators due to increasing complaints of leaks and intermittent loose connections that could affect device function during medical procedures.

    Product
    INDEFLATOR Plus 30 - REF 1000183 WPL2122277-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0943-2022·2022-04-20

    Ventilator trolley mounting brackets can detach and cause device to fall

    The mounting brackets on Breas Ventilator Trolleys can become detached, allowing ventilators to fall. This poses an injury risk to people near the equipment.

    Product
    Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0941-2022·2022-04-20

    Medline Laryngeal Masks recalled due to potential cuff disconnection

    Medline Industries is recalling approximately 8,990 cases of Standard PVC Laryngeal Masks distributed nationwide because the mask cuff may disconnect from the breathing tube.

    Product
    Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0939-2022·2022-04-20

    Cardiac electrode fails electrical safety test; defibrillation may not work

    The CLARAVUE Pre-wired Electrode does not meet electrical safety standards for defibrillators. It may not deliver effective electrical charge during emergency defibrillation.

    Product
    CLARAVUE Pre-wired Electrode - IP SET 6V RT ADULT-US Model: 32028780 50603-US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2022·2022-04-20

    Abbott Vascular 20/30 Indeflator Recalled for Leaks and Connection Failures

    Abbott Vascular recalls 20/30 Indeflator medical devices due to increased complaints of leaks and loose connections. The recall affects 17 product lots distributed nationwide and internationally.

    Product
    20/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0936-2022·2022-04-20

    Recalled CLARAVUE Pre-wired Electrode Set May Fail During Defibrillation

    Graphic Controls is recalling CLARAVUE Pre-wired Electrode sets because they fail to meet electrical safety specifications for defibrillators, potentially delivering inadequate charge during emergency treatment.

    Product
    CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0904-2022·2022-04-20

    AccessPLUS hemostasis valves recalled for internal guidewire entrapment risk

    Merit Medical is recalling AccessPLUS Large Bore Hemostasis Valves due to an internal design gap that can trap guidewires, potentially delaying medical procedures.

    Product
    AccessPLUS Large Bore Hemostasis Valves, Catalog Code: 580758001, 580774001, IN8152/C, K04-01197, K05T-01863, K09-09102B, K09-10388A, K09-12917, K09-13501AP, K10-05457AP, K10-05635, K10-05868P, K10-05872P, K12-08303, K12-10346, K12-10375, K12-10724AP, K12-10962, K12-11413, MAP150
    Category
    Medical Device
    Distribution
    49 states