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 the agency’s own highest classification or reported deaths or serious injuries, 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

31026–31050 of 40449

ModerateFDA (Devices)·Z-0859-2016·2016-03-02
Medtronic Spinal Cord Stimulation Leads Recalled for Labeling Deficiencies
Medtronic is recalling Specify 5-6-5 and 2x8 spinal cord stimulation leads because the labeling does not adequately distinguish between permanent implant and trialing use.
Product
Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0873-2016·2016-03-02
Stryker T2 K-Wire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0885-2016·2016-03-02
Biomet Recalls HipLOC CHS Plate/Lag Screw Introducer Due to Sizing Defect
Biomet is recalling 23 HipLOC CHS Plate/Lag Screw Introducers because some units are undersized and fail to accept the coupling screw.
Product
HipLOC CHS Plate/Lag Screw Introducer
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0838-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling specific CR Flex and Natural Knee prosthesis components because the LDPE packaging bag adheres to the polished implant surface.
Product
CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0839-2016·2016-03-02
Zimmer Biomet Recalls Natural-Knee II Femoral Prostheses Due to Packaging Defect
Zimmer Biomet is recalling 13,483 Natural-Knee II femoral prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0863-2016·2016-03-02
Hospira Symbiq Infusion Pumps Recalled for Missing Rubber Stop Pad
Hospira is recalling 6,634 Symbiq infusion pumps because the pole clamp assemblies may be missing a rubber stop pad. The devices were distributed to healthcare facilities in the U.S. and Canada.
Product
The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1018-2016·2016-03-02
Sorin Group Recalls CDI H/S Cuvettes Due to Connection Error
Sorin Group USA is recalling CDI H/S Cuvettes because they may fail to connect properly with the probe, causing the monitor to display an error and preventing blood parameter values from displaying.
Product
CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0865-2016·2016-03-02
Cook Inc. Recalls Flexor Check-Flo Introducers Due to Incorrect Packaging
Cook Inc. is recalling 25 Flexor Check-Flo Introducers because some packages labeled as 6.0Fr actually contained 5.0Fr devices.
Product
Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0823-2016·2016-03-02
Leica Bond Polymer Refine Detection System Recalled for Inadequate Staining
Leica Microsystems is recalling the Bond Polymer Refine Detection System because it may not provide adequate staining when used with specific protocols.
Product
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
Category
Medical Device
Distribution
37 states
ModerateFDA (Devices)·Z-0870-2016·2016-03-02
Stryker Gamma K-Wire Recall Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0841-2016·2016-03-02
Zimmer Biomet Recalls NexGen LPS Flex Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS Flex femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0871-2016·2016-03-02
Stryker Gamma Guide Pin Recalled for Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling Gamma Guide Pins because a packaging review indicated that the seal integrity of the pouch may be decreased.
Product
Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0837-2016·2016-03-02
Zimmer Biomet Recalls Gender PFJ Femoral Components Due to Packaging Defect
Zimmer Biomet is recalling 5,103 Gender PFJ Femoral Components because the LDPE packaging bag adheres to the implant surface. The device is distributed worldwide.
Product
Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0846-2016·2016-03-02
Zimmer Biomet Recalls Versus 6 Inch Beaded FC 1 Hip Prosthesis
Zimmer Biomet is recalling 130 units of Versus 6 Inch Beaded FC 1 hip prostheses because the packaging bag adheres to the implant surface.
Product
VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0842-2016·2016-03-02
Zimmer Biomet Recalls Knee Implants Due to Packaging Adhesion Defect
Zimmer Biomet is recalling 4,567 knee prosthesis units because the LDPE packaging bag adheres to the polished implant surface.
Product
PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0829-2016·2016-03-02
Cardiac Science Defibrillation Electrodes Recalled for Impedance Issues
Cardiac Science is recalling specific defibrillation electrodes that may develop high electrical impedance, causing AED self-test failures.
Product
9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators…
Category
Medical Device
Distribution
3 states
ModerateFDA (Devices)·Z-0830-2016·2016-03-02
Zimmer Biomet Recalls LPS-FLEX GSF OPT Knee Prostheses Due to Packaging Defect
Zimmer Biomet is recalling LPS-FLEX GSF OPT knee prostheses because the LDPE bag adheres to the implant surface. The recall covers 84,396 units distributed worldwide.
Product
LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes¿ Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0884-2016·2016-03-02
Stryker T2 K-Wire Recall Due to Potential Pouch Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0882-2016·2016-03-02
Stryker T2 Fixation K-Wire Recall Due to Packaging Seal Integrity Concerns
Stryker Howmedica Osteonics Corp. is recalling T2 Fixation K-Wires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0880-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased, potentially affecting sterility.
Product
Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0831-2016·2016-03-02
Zimmer Biomet Recalls NexGen CR-FLEX Knee Implants Due to Packaging Defect
Zimmer Biomet is recalling NexGen CR-FLEX knee prostheses because the LDPE packaging bag adheres to the implant surface. The recall covers 42,064 units distributed worldwide.
Product
NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0836-2016·2016-03-02
Zimmer Biomet Recalls Knee Prosthesis Due to Packaging Adhesion Issue
Zimmer Biomet is recalling Zimmer Uni High Flex Precoat Femoral knee prostheses because the LDPE packaging bag adheres to the implant surface.
Product
ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0862-2016·2016-03-02
Siemens Recalls Syngo Plaza PACS Software Due to Display and Access Issues
Siemens is recalling 68 units of Syngo Plaza PACS software to fix bugs affecting image display, saving, and access controls.
Product
Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0832-2016·2016-03-02
Zimmer Biomet Recalls NexGen LPS-FLEX Femoral Knee Implants
Zimmer Biomet is recalling NexGen LPS-FLEX femoral knee implants because the packaging bag adheres to the polished implant surface.
Product
NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0834-2016·2016-03-02
Zimmer Biomet Recalls NexGen Knee Implants Due to Packaging Adhesion
Zimmer Biomet is recalling NexGen Knee LPS and Lock femoral components because the LDPE packaging bag adheres to the polished implant surface.
Product
NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due…
Category
Medical Device
Distribution
Distributed nationwide

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31026–31050 of 40449