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.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

6876–6900 of 13652

ModerateFDA (Devices)·Z-1404-2024·2024-04-10
Exactech Shoulder Implant Components Recalled for Nonconforming Oxygen Barrier Packaging
Exactech Inc. is recalling 6,678 shoulder glenoid implant components because they were packaged in vacuum bags lacking the required oxygen barrier layer made of Ethylene Vinyl Alcohol (EVOH).
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-02, b) Medium, Item Number 314-02-03, c) Large, Item Number 314-02-04, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1474-2024·2024-04-10
Karl Storz Uvula Retractors Recalled for Inadequate Reprocessing Validation
Karl Storz Endoscopy is recalling 147 units of the REF 723014 Uvula Retractor due to inadequate reprocessing validation. The manufacturer cannot demonstrate that current sterilization methods ensure proper device sterility.
Product
Karl Storz SE & CO. KG, REF 723014, Uvula Retractor, For Veterinary Use Only, Rx Only
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1475-2024·2024-04-10
3M Tube Securement Devices Recalled for Missing Film Layer and Shape Defects
3M is recalling 265,435 tube securement devices (REF 1500U and 1501U) due to manufacturing defects including missing or partial top film layers and incorrect device shape from excess material not properly removed.
Product
3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO, REF 1500U, Sterile; and 3M Tube Securement Device, Large, 2.2 IN/PO x 3.5 IN/PO, REF 1501U, Sterile. Product is packaged 1 device per pouch, 25 pouches per primary carton, and 4 primary cartons per shipper box.
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
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
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-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-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-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-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-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-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
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
0 states
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-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-1389-2024·2024-04-03
Epix Universal Clip Applier Recalled for Clip Load Failure Risk
Applied Medical Resources is recalling the Epix Universal Clip Applier because the device may fail to load a clip after the trigger is actuated, potentially impacting surgical procedures.
Product
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME, GK1011, K-19459, GK1014, K-18031 STANDARD KIT, GK1018, K-20735 STANDARD KIT,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1361-2024·2024-04-03
Thermalon Sinus Compress Recalled for Potential Mold and Mildew
Bruder Healthcare Company is recalling 1,416 units of Thermalon Sinus Compress (Item Number 24332) due to potential mold and mildew growth from excessive moisture exposure. Affected lot numbers are M053160 and M053570.
Product
Thermalon Sinus Compress, Item Number 24332
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1378-2024·2024-04-03
Baxter Supple Peri-Guard Repair Patch Recall Due to Endotoxin Contraindication
Baxter is recalling Supple Peri-Guard Repair Patch units due to elevated endotoxin levels that may exceed allowable limits for cerebrospinal fluid-contacting devices. The product should not be used in neurosurgery.
Product
Baxter Supple Peri-Guard Repair Patch (legacy product codes): a) PC0404SNBIO, b) PC0608NSBIO, c) PC0814SNBIO, d) PC1016SNBIO
Category
Medical Device
Distribution
5 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-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-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-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
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

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6876–6900 of 13652