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

30926–30950 of 40325

HighFDA (Devices)·Z-0918-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0824-2016·2016-03-02
Siemens BCS Blood Coagulation Analyzer Recall for False Results
Siemens is recalling BCS Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low PT INR values when testing specific types of patient samples.
Product
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2016·2016-03-02
Olympus Video Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc is recalling one Olympus video colonoscope because excessive pressure may cause the internal coil pipe to detach, affecting angulation.
Product
Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0960-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 43 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0868-2016·2016-03-02
Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2016·2016-03-02
Olympus GIF-H180 Video Gastroscope Recalled for Distal Coil Detachment
Integrated Medical Systems Inc is recalling 275 Olympus GIF-H180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0864-2016·2016-03-02
EKOS EkoSonic Endovascular System Recalled for Incorrect Working Length Labeling
EKOS Corporation is recalling 10 units of the EkoSonic Endovascular System because the device is labeled with a 135 cm working length, but the actual working length is 106 cm.
Product
EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic…
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0849-2016·2016-03-02
Zimmer Biomet Recalls Versys Hip Prostheses Due to Packaging Adhesion
Zimmer Biomet is recalling 4,844 Versys hip prostheses because the LDPE packaging bag adheres to the polished implant surface.
Product
VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid…
Category
Medical Device
Distribution
Distributed nationwide
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

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30926–30950 of 40325