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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7626–7650 of 39968

  • ModerateFDA (Devices)·Z-1461-2024·2024-04-10

    Halyard surgical hood mislabeled as surgical cap at dispenser

    O&M Halyard is recalling approximately 75,000 surgical hoods mislabeled as surgical caps at the dispenser level.

    Product
    HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1422-2024·2024-04-10

    Exactech Equinoxe Reverse Shoulder Humeral Liners Recalled for Nonconforming Packaging

    Exactech, Inc. is recalling 24,303 units of Equinoxe Reverse Shoulder humeral liners due to nonconforming vacuum-bag packaging. The bags lack the required oxygen barrier layer, failing to meet packaging specifications.

    Product
    Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1413-2024·2024-04-10

    Exactech Equinoxe Shoulder Implants Recalled for Nonconforming Packaging

    Exactech is recalling 12,643 units of Equinoxe CAGE GLENOID shoulder implants because packaging lacks a required oxygen barrier layer. Units were vacuum-sealed without the proper Ethylene Vinyl Alcohol (EVOH) barrier.

    Product
    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1399-2024·2024-04-10

    BD Phoenix Yeast ID Panel Recalled for Incorrect Substrate Placement

    Becton Dickinson recalls BD Phoenix Yeast ID Panel units (Lot 3312180) due to misplaced esculin substrate that triggers system abortion. No injuries reported.

    Product
    BD Phoenix Yeast ID Panel is a self-inoculating (when used with a BD Phoenix Automated Microbiology System) polystyrene panel (tray) containing control wells and substrate wells with dried biochemical substrates that use traditional qualitative microbiology methods such as fermen
    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-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
  • 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-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-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-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-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-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
  • HighFDA (Devices)·Z-1368-2024·2024-04-03

    Endoscopic Lens Cleaner Recalled for Instruction Discrepancy Risk

    Olympus recalls InstaClear Lens Cleaner devices due to inconsistencies between Japanese and English instruction manuals that could cause component separation during endoscopic procedures.

    Product
    InstaClear Lens Cleaner-indicated for use during routine diagnostic procedures and during endoscopic sinus surgery. Model Number: LCS1500UNOL LCS1800UNST LCS4K00UNOL LCS1530BTOL LCS1830BTST LCS4K30BTOL LCS1530TPOL LCS1830TPST LCS4K30TPOL LCS1545BTOL LCS1845BTST LCS4K
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1370-2024·2024-04-03

    Alcon bulb irrigation syringes recalled due to sterile barrier compromise

    Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.

    Product
    SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1395-2024·2024-04-03

    Emergency traction splint adhesive failure may compromise device function

    Emergency Products & Research is recalling 190,000 O.T.D. traction splints because adhesive may fail to secure the pole insert, potentially compromising function in emergency medical situations.

    Product
    O.T.D - Optimum Traction Device - Street Orange. Single use traction splint.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1391-2024·2024-04-03

    Puritan HydroFlock Collection Device Distributed with Wrong Product Code

    Puritan Medical Products distributed HydroFlock Sterile Flocked Collection Devices labeled as Part Number 25-3317-H, Lot S1014 that actually contain product code 25-3317-U. Approximately 232,500 units were affected.

    Product
    HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1373-2024·2024-04-03

    Clinical Laboratory Quality Control Device Recalled for Diluent Assembly Error

    Ortho-Clinical Diagnostics is recalling 11,224 units of VITROS Performance Verifier II due to incorrect diluent assembly, which may produce inaccurate quality control results and potentially erroneous patient test results.

    Product
    VITROS Performance Verifier II
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1388-2024·2024-04-03

    Epix Universal Clip Applier Recalled for Potential Clip Loading Failure

    Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load the surgical clip after the trigger is actuated. Units were distributed worldwide.

    Product
    Epix Universal Clip Applier, REF: CA500, STERILEEO
    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-1359-2024·2024-04-03

    Thermalon Eye Compress Recalled Due to Potential Mold and Mildew Growth

    Bruder Healthcare Company is recalling Thermalon Eye Compress Item 2434 from certain lots due to potential mold and mildew growth from excessive moisture exposure. Affected products were distributed in the US and Canada.

    Product
    Thermalon Eye Compress, Item Number 2434
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2024·2024-04-03

    Baxter Peri-Guard Repair Patch Contraindication Added for Neurosurgery

    Baxter Healthcare has added a contraindication to Peri-Guard Repair Patch instructions, restricting use in neurosurgery because endotoxin levels may exceed allowable limits for cerebrospinal fluid-contacting devices.

    Product
    Baxter Peri-Guard Repair Patch (new product codes): a) PG0404, b) PG0608, c) PG0814, d) PG1016, e) PG1225
    Category
    Medical Device
    Distribution
    5 states
  • 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-1390-2024·2024-04-03

    Boston Scientific iSLEEVE Expandable Introducer Sets Recalled for Hemostatic Valve Leak

    Boston Scientific is recalling specific batches of the iSLEEVE Expandable Introducer Set due to hemostatic valve leaks affecting 4,060 devices. The devices are distributed in the US, Canada, and worldwide.

    Product
    Boston Scientific iSLEEVE EXPANDABLE Introducer Set REF H74939349140, facilitates femoral access to the vascular system
    Category
    Medical Device
    Distribution
    Distributed nationwide