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

7576–7600 of 39844

ModerateFDA (Devices)·Z-1412-2024·2024-04-10
Shoulder Implant Components Recalled for Nonconforming Packaging
Exactech Inc. is recalling 11,031 shoulder implant components due to nonconforming vacuum bag packaging lacking a required oxygen barrier layer. The missing Ethylene Vinyl Alcohol (EVOH) layer could allow oxygen exposure to the UHMWPE material.
Product
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
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
ModerateFDA (Devices)·Z-1423-2024·2024-04-10
Exactech Equinoxe Reverse Shoulder Implant Liners Recalled for Oxygen Barrier Packaging Defect
Exactech recalls 3,648 reverse shoulder implant liners due to nonconforming packaging. Vacuum bags lack required oxygen barrier (EVOH) protection against material degradation.
Product
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
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-1400-2024·2024-04-10
Hill-Rom PRO+ Pressure Relief Mattress Service Correction Reassessment
Baxter Healthcare is reassessing 232 Hill-Rom PRO+ pressure relief mattresses due to identified inconsistencies in service records from a previous correction. These mattresses must be verified to confirm corrections were properly applied.
Product
Hill-Rom PRO+ 36" MRS Surface, REF P7924A03, The pro+ mattress is intended for patient support and for the prevention and/or treatment of pressure injuries.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1414-2024·2024-04-10
Exactech Equinoxe Shoulder Components Recalled for Nonconforming Packaging
Exactech is recalling 3,436 units of shoulder arthroplasty components due to nonconforming packaging that lacks a required oxygen barrier layer. The products may not be adequately protected against oxidative degradation.
Product
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1409-2024·2024-04-10
Exactech Equinoxe Shoulder Arthroplasty Components Recalled for Defective Packaging
Exactech recalls 39 UHMWPE shoulder arthroplasty components due to nonconforming vacuum packaging that lacks the required oxygen barrier layer.
Product
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-04-32, b) 41, 44, 47, 50 head, Medium, Item Number 314-04-33, c) 44, 47, 50, 53 head, Large, Item Number 314-04-34, d) 44,
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1420-2024·2024-04-10
Exactech Equinoxe Humeral Liner Shoulder Implant Recalled for Nonconforming Packaging
Exactech Equinoxe Humeral Liners used in shoulder surgery are being recalled due to nonconforming packaging. Approximately 2,806 units lack the required oxygen barrier layer in their vacuum-bag packaging.
Product
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1393-2024·2024-04-10
X-Guide Handpiece Adaptor Sleeve 3 Manufacturing Defect Recall
X-NAV Technologies is recalling the X-Guide Handpiece Adaptor Sleeve 3 due to a manufacturing defect causing incorrect geometry that prevents proper fit. The recall affects 154 units distributed worldwide.
Product
X-Guide Handpiece Adaptor Sleeve 3, Model P010727
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
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-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
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-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
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-1365-2024·2024-04-03
Thermalon Stye Compress recalled due to potential mold and mildew
Bruder Healthcare Company is recalling Thermalon Stye Compress (Item Number 24352) in certain lots due to potential mold and mildew growth from excessive moisture exposure. No illnesses have been reported.
Product
Thermalon Stye Compress, Item Number 24352
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1394-2024·2024-04-03
IV Start Kit Recalled Due to Supplier Saline Syringe Issue
Medical Action Industries is recalling 206,200 IV Start Kits due to saline syringes recalled by the supplier. The affected kits were distributed in Minnesota and North Dakota.
Product
IV Start Kit, containing 1 Saline Syringe 5ml, REF 74654, 100 kits/case, Sterile.
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-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

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7576–7600 of 39844