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

21176–21200 of 40339

HighFDA (Devices)·Z-1036-2019·2019-03-27
ConvaTec Recalls Feeding Tubes Due to Potential Sterile Barrier Breach
ConvaTec is recalling specific lots of Feeding Tube Metric devices because an internal assessment found a potential breach in the sterile barrier.
Product
Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1019-2019·2019-03-27
AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts
AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.
Product
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1037-2019·2019-03-27
ConvaTec Recalls Nelaton Urinary Catheters Due to Sterile Barrier Breach Risk
ConvaTec is recalling Nelaton Urinary Catheters because an internal assessment found a potential breach in the sterile barrier, which could compromise the device's sterility.
Product
Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1027-2019·2019-03-27
CP Medical Recalls Sterile Surgical Sutures Due to Potential Sterility Compromise
CP Medical Inc is recalling Plain and Chromic Gut Absorbable Surgical Sutures because routine endotoxin testing showed an out-of-limit result, potentially compromising sterility.
Product
Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box. Product Usage: Plain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1020-2019·2019-03-27
FDA Recalls 850 Units of Covidien Force TriVerse Electrosurgical Devices
The FDA is recalling 850 units of the Covidien Force TriVerse electrosurgical device due to potential sterile packaging compromise.
Product
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1015-2019·2019-03-27
Siemens Dimension Vista 1500 Analyzer Recall Due to Water Module Contamination
Siemens is recalling 5,373 Dimension Vista 1500 analyzers because specific water purification modules may cause falsely elevated triglyceride results.
Product
Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1033-2019·2019-03-27
ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure
ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick because a sample failed to meet tensile strength specifications.
Product
Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1014-2019·2019-03-27
Siemens Dimension Vista 500 Analyzer Recall for Water Module Contamination
Siemens is recalling 5,373 Dimension Vista 500 analyzers because specific Millipore water purification modules may cause falsely elevated triglyceride results.
Product
Dimension Vista 500, Analyzer, chemistry Model no. 10284473
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1029-2019·2019-03-27
Smith & Nephew Recalls Mislabelled High Offset StikTite Coated Hip Stems
Smith & Nephew is recalling 9 units of hip stems where the outer label incorrectly identified the product as size "1" instead of the actual size "-1".
Product
smith&nephew SMF(TM) HIGH OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1H SIZE, STEM, REF 713552511
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1038-2019·2019-03-27
ConvaTec Recalls FilterFlow Suction Handles Due to Sterile Barrier Breach Risk
ConvaTec is recalling 124,000 FilterFlow Suction Handles because an internal assessment found a potential breach in the sterile barrier.
Product
FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1035-2019·2019-03-27
ConvaTec Recalls Forceps Blue Due to Potential Sterile Barrier Breach
ConvaTec, Inc. is recalling Forceps Blue, disposable sterile forceps, because an internal assessment confirmed the potential for a breach in the sterile barrier.
Product
Forceps Blue, disposable, sterile, 100 eaches per sales unit. Product Usage: Forceps are sterile disposable devices intended for use during clinical procedures to grasp, manipulate, maneuver or assist with the removal of debris, particulates or wound tissue. Typically…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1032-2019·2019-03-27
ACell Recalls Gentrix Surgical Matrix Thick Due to Tensile Strength Failure
ACell, Inc. is recalling one lot of Gentrix Surgical Matrix Thick devices because a sample failed to meet tensile strength specifications.
Product
Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1028-2019·2019-03-27
Smith & Nephew Recalls Mislabelled Hip Stem Implants Due to Size Error
Smith & Nephew is recalling 58 hip stem implants because the outer label incorrectly identified the product as size "1" instead of "-1".
Product
smith&nephew SMF(TM) STANDARD OFFSET STIKTITE(TM) COATED STEM 12/14 TAPER -1 SIZE, STEM, REF 713552510
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1018-2019·2019-03-27
Randox Fructosamine Control 3 Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 133 kits of Fructosamine Control 3 because the assigned value was decreased by 25%. The product is used for in vitro calibration.
Product
Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1017-2019·2019-03-27
Randox Fructosamine Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 141 kits of Fructosamine Control 1 because the assigned value was decreased by 25%.
Product
Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-1016-2019·2019-03-27
Randox Fructosamine Calibrator Recall Due to Value Reassignment
Randox Laboratories is recalling 85 kits of Fructosamine Calibrator FR2993 because the assigned value was decreased by 25%.
Product
Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.
Category
Medical Device
Distribution
4 states
LowFDA (Devices)·Z-1024-2019·2019-03-27
Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Product
Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1034-2019·2019-03-27
Agfa Radiographic Film Recalled for Visible Pinholes in Images
Agfa N.V. is recalling specific lots of PET Plates Coated Film-MONOMEDBV2S2 radiographic film because inhomogeneous coating solutions cause visible pinholes in images.
Product
PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1026-2019·2019-03-27
Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filter Sets to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Product
Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1023-2019·2019-03-27
Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.
Product
Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1025-2019·2019-03-27
Cook Medical Recalls Celect Platinum Vena Cava Filters for Labeling Updates
Cook Medical is recalling Celect Platinum Vena Cava Filters to update the Instructions for Use. The recall affects 9,173 units distributed nationwide.
Product
Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1022-2019·2019-03-27
Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use. The products were distributed nationwide.
Product
Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Catalog Number IGTCFS-65-1-JUG-TULIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1021-2019·2019-03-27
Cook Medical Recalls Gunther Tulip Vena Cava Filters for Labeling Updates
Cook Medical is recalling 9,173 Gunther Tulip Vena Cava Filter Sets to update the Instructions for Use.
Product
Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0992-2019·2019-03-20
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Products Na+ Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products Na+ Slides because imprecision in the affected lot may produce biased patient sample and quality control fluid results.
Product
VITROS Chemistry Products Na+ Slides, Catalog Number 8379034 For in vitro diagnostic use only. VITROS Na+ Slides quantitatively measure sodium (Na+) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
20 states
SevereFDA (Devices)·Z-0979-2019·2019-03-20
Cook Transseptal Needle Recalled for Missing Back Bevel
Cook Inc. is recalling 100 units of Transseptal Needles manufactured without a back bevel on the needle tip, which could damage the introducer during insertion.
Product
Cook Transseptal Needle, Reference Number TSNC-18-71.0, Order Number G02364. For transseptal left heart access in both diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide

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21176–21200 of 40339