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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5801–5825 of 27364

  • HighFDA (Devices)·Z-1456-2024·2024-04-10

    ATTUNE AFFIXIUM Knee Implant Component Recalled for Incorrect Labeling

    DePuy Orthopaedics is recalling ATTUNE AFFIXIUM Cementless Fixed Bearing Knee implants (Size 6) due to incorrect labeling. The affected product includes Model No. 150621006 with Lot JA06A0252.

    Product
    ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1416-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Packaging Defect

    Exactech humeral liners used in shoulder replacement are recalled because the vacuum packaging lacks a required oxygen barrier layer (EVOH), violating established packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2024·2024-04-10

    Covidien Auto Suture Trocar Recall: Potential Seal Disengagement With Incorrect Mesh Use

    Covidien is recalling 93,673 Auto Suture Blunt Tip Trocars due to potential seal disengagement when mesh products are used incorrectly. Improper use could compromise device integrity during laparoscopic procedures.

    Product
    Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1445-2024·2024-04-10

    Suture Removal and Staple Remover Kits Recalled for Weak Seal

    Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.

    Product
    Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1325-2024·2024-04-03

    Stay-safe Luer Lock catheter extension recalled for chemical leachables

    Fresenius is recalling 663,221 stay-safe Luer Lock catheter extension units nationwide due to chemical leachables (NDL PCBAs) identified in the tubing.

    Product
    stay-safe /Luer Lock Catheter Ext. 12 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1323-2024·2024-04-03

    Catheter Extension Tubing Recalled Due to Identified Leachable Substances

    Fresenius Medical Care is recalling 114,982 stay-safe Safe Lock Catheter Extensions due to peroxide cross-linked tubing leachables. Patients and healthcare providers are advised to discontinue use and contact the manufacturer for replacement.

    Product
    stay-safe /Safe Lock Catheter Ext. 12 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1302-2024·2024-04-03

    Boston Scientific steerable sheath devices recalled due to manufacturing defect risk

    Boston Scientific is recalling 461 POLARSHEATH Steerable Sheath devices due to a manufacturing tooling error that may cause inner sheath delamination and potential fragment release during medical procedures.

    Product
    Boston Scientific POLARSHEATH Steerable Sheath 12F, REF M004CRBS3050
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1326-2024·2024-04-03

    Catheter Extension Recalled by Fresenius Due to Chemical Leachables

    Fresenius is recalling 479,978 stay-safe Luer Lock Catheter Extensions due to chemical leachables in the tubing. Healthcare providers should contact the manufacturer for replacement information.

    Product
    stay-safe /Luer Lock Catheter Ext. 18 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1374-2024·2024-04-03

    Obsidio Conformable Embolic coils recalled for bowel-ischemia risk

    Boston Scientific recalled 985 Obsidio Conformable Embolic coils because using the aliquot delivery technique for lower GI bleeding poses a high risk of bowel ischemia requiring major surgery.

    Product
    Obsidio Conformable Embolic, Material Numbers (UPN): a) M0013972001010, b) M0013972101010
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1286-2024·2024-04-03

    Nimbus II Infusion Pump Systems Recalled for Multiple Potential Device Failures

    InfuTronix is recalling 52,328 Nimbus II Infusion Pump Systems due to potential failure modes including battery failure, system errors, drug product leakage, flow rate issues, and housing damage. The devices will no longer be available or supported after June 20, 2024.

    Product
    Nimbus II Infusion System; Nimbus II PainPRO IT1053; Nimbus II Flex IT1062; Nimbus II Plus IT1078; Nimbus II EpiD IT1124; Nimbus II EMS IT1063; Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1382-2024·2024-04-03

    Surgical Tracecarts Recalled Due to Defective Foley Catheter Component

    DeRoyal Industries is recalling 134 GeoMed Custom Tracecarts distributed in Florida that contain a recalled Foley catheter component. Affected units carry specific lot numbers with expiration dates from February 2024 through May 2025.

    Product
    GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-1285-2024·2024-04-03

    Nimbus Ambulatory Infusion Pump recalled due to multiple failure modes

    InfuTronix is recalling Nimbus Infusion Pump Systems (Nimbus Flex, Nimbus PainPro) due to potential battery failure, system errors, drug leakage, flow rate abnormalities, and housing damage. About 52,328 units are affected nationwide.

    Product
    Nimbus Administration Set; Nimbus Flex; Nimbus PainPro (a.k.a. Halo Ambulatory Infusion System); Catalog Number IT1025. Ambulatory Infusion Pump and components
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1327-2024·2024-04-03

    FDA Recalls Fresenius Catheter Extension Tubing Due to Chemical Leachables

    Fresenius Medical Care is recalling 105,700 stay-safe /Luer Catheter Extension 6 in devices nationwide due to chemical leachables identified in the peroxide cross-linked tubing. FDA classified this as a Class I recall.

    Product
    stay-safe /Luer Catheter Ext. 6 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1324-2024·2024-04-03

    FDA Recalls stay-safe Luer Lock Adapter for Chemical Leachables

    The FDA is recalling approximately 828,954 stay-safe Luer Lock Adapters due to chemical leachables identified in the peroxide cross-linked tubing. The nationwide recall affects all lots of Model Number 050-95003.

    Product
    stay-safe /Luer Lock Adapter 4 in
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1358-2024·2024-04-03

    Bio-Rad QXDx BCR-ABL diagnostic kit recalled for calibration errors

    Bio-Rad Laboratories is recalling a diagnostic test kit due to incorrect calibrations and controls that may produce inaccurate test results. Patients and healthcare providers should contact the manufacturer.

    Product
    Bio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1381-2024·2024-04-03

    Medivance Neonatal ArcticGel Pads Recalled for Reduced Water Flow

    Medivance Inc. is recalling Neonatal ArcticGel Pads due to reduced water flow that may prevent proper heating or cooling performance in neonatal temperature management systems. No injuries have been reported.

    Product
    Medivance Neonatal ArcticGel Pads, REF: 31802, 3180202, 31802C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2024·2024-04-03

    RELAY PRO Thoracic Stent-Graft System recalled for incorrect size

    Bolton Medical Inc. is recalling 21 RELAY PRO Thoracic Stent-Graft Systems because the stent-graft inside the delivery system is the incorrect size.

    Product
    RELAY PRO Thoracic Stent-Graft System, containing one endovascular stent-graft system, IFU, and patient tracking card, sterile: (a) Part number 28-M4-34-100-34U; (b) Part number 28-M4-30-095-30U; (c) Part number 28-M4-46-155-46U; (d) Part number 28-M4-32-155-32S; (e) Part
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1371-2024·2024-04-03

    Aptima CMV Quant Assay Recalled for Invalid Results with Plasma Specimens

    Hologic is recalling 684 kits of the Aptima CMV Quant Assay diagnostic test; when used with plasma specimens, the assay may generate error codes that invalidate test results. Lot number 402941 is affected.

    Product
    Aptima CMV Quant Assay, Reference numbers: AW-22600-001, AW-25509-001, and AW-26381-001 Amplification Reagent, Enzyme Reagent, Promoter Reagent, Amplification Reconstitution Solution, Enzyme Reconstitution Solution, Promoter Reconstruction solution, Target capture Reagent, Recons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1366-2024·2024-04-03

    MediBeads Neck Wrap recalled for potential mold and mildew growth

    Bruder Healthcare Company is recalling 430 units of MediBeads Neck Wrap (Item 34320) because the product may have been exposed to excessive moisture, creating potential for mold and mildew growth. Lot Number M053300, distributed in the US and Canada.

    Product
    MediBeads Neck Wrap, Item Number 34320
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2024·2024-04-03

    Baxter Peri-Guard Repair Patch contraindicated for neurosurgical use

    Peri-Guard Repair Patch is now contraindicated for neurosurgery because its endotoxin level may exceed the limit allowable for cerebrospinal fluid-contacting devices. Product instructions have been updated.

    Product
    Baxter Peri-Guard Repair Patch (legacy product codes): a) PC0404NBIO, b) PC0608NBIO, c) PC0814NBIO, d) PC1016NBIO
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1362-2024·2024-04-03

    Thermalon Back Wrap Recalled for Potential Mold and Mildew Growth

    Certain lots of Thermalon Back Wrap may have been exposed to excessive moisture, potentially resulting in mold and mildew growth. The product is distributed nationwide in the US and Canada.

    Product
    Thermalon Back Wrap, Item Number 24312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1380-2024·2024-04-03

    Baxter Supple Peri-Guard Repair Patch contraindicated for neurosurgery due to endotoxin

    Baxter is recalling specific lot codes of Supple Peri-Guard Repair Patch because endotoxin levels may exceed limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.

    Product
    Baxter Supple Peri-Guard Repair Patch (new product codes): a) SPG0404, b) SPG0406, c) SPG0608, d) SPG0814, e) SPG1016
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1396-2024·2024-04-03

    Certain OptiCross Coronary Imaging Catheters recalled for manufacturing defect

    Boston Scientific recalls certain batches of OptiCross Coronary Imaging Catheters manufactured with an incorrect voltage setting that may cause decreased image brightness.

    Product
    OptiCross Coronary Imaging Catheter, REF H749518080120
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1369-2024·2024-04-03

    Cystatin C Calibrator Series CVS 2699 Recalled for Calibration Bias

    Randox Laboratories is recalling Cystatin C Calibrator Series CVS 2699 because it runs with negative bias compared to other methods, which could affect test accuracy on automated analyzers.

    Product
    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1375-2024·2024-04-03

    Olympus Insufflation Unit UHI-4 Recalled for Air Supply Failure

    Olympus recalled 3,172 UHI-4 insufflation units due to the front panel LED turning off, which causes loss of air supply. All serial numbers nationwide are affected.

    Product
    Insufflation unit, UHI-4.
    Category
    Medical Device
    Distribution
    Distributed nationwide