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

7601–7625 of 40007

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-1405-2024·2024-04-10
Exactech Equinoxe Shoulder Components Recalled for Packaging Defect
Exactech is recalling 6,840 units of Equinoxe shoulder implant components because their vacuum packaging lacks the required oxygen barrier layer (EVOH). The defect could potentially allow material degradation during storage.
Product
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2024·2024-04-10
Exactech Shoulder Implant Liners Recalled for Defective Oxygen Barrier Packaging
Exactech has recalled 591 units of Equinoxe Reverse Shoulder humeral liners because the packaging lacks a required oxygen barrier layer (EVOH). The nonconforming packaging may affect material integrity of these surgical implants.
Product
Exactech Equinoxe REVERSE SHOULDER,46mmConstrained Humeral Liner, a) +0mm, Item number 320-46-10, b) +2.5mm, Item Number 320-46-13; Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1457-2024·2024-04-10
Signia Surgical Stapler Reload recalled for uncontrolled articulation
Covidien is recalling Signia Small Diameter Curved Tip Intelligent Reload surgical stapler reloads due to potential malfunction that could disrupt the staple line during use. The affected reloads may articulate uncontrollably due to unsecured components.
Product
Signia" Small Diameter Curved Tip Intelligent Reload, Model SIGSDS30CTVT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2024·2024-04-10
Medline Swabsticks PVP Product Recalled for Weak Seal Risk
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Product
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
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
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-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-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-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-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-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-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-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-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-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-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
ModerateFDA (Devices)·Z-1421-2024·2024-04-10
Exactech Equinoxe Shoulder Arthroplasty Liner Recalled for Nonconforming Packaging
Exactech recalls 447 units of Equinoxe Constrained Humeral Liner due to nonconforming packaging lacking required oxygen barrier layer (EVOH). Affected units were distributed nationwide and internationally.
Product
Exactech Equinoxe Constrained Humeral Liner: Item Numbers: a) 320-40-10, b) 320-40-13, Shoulder Arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
CriticalCPSC·24179·2024-04-04
Essential Medical Supply Reannounces Adult Bed Rails Recall; Entrapment and Asphyxia
Essential Medical Supply is reannouncing a recall of approximately 272,000 Endurance® Hand Bed Rails due to entrapment and asphyxiation hazards. Two additional deaths have been reported since the original 2021 recall.
Product
Endurance® Hand Bed Rails
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-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

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7601–7625 of 40007