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

37751–37775 of 40449

HighFDA (Devices)·Z-2031-2013·2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, specifically mixing micro and standard parts.
Product
90597004109 Articular Surface CR ART SURF AE56/STR GRN 09MM, Rx, Sterile; 90597004110 Articular Surface CR ART SURF AE56/STR GRN 10MM, Rx, Sterile; 90597004112 Articular Surface CR ART SURF AE56/STR GRN 12MM, Rx, Sterile; 90597004114 Articular Surface CR ART SURF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2043-2013·2013-08-28
Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations
Zimmer is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597103110 Provisional CR ART SURF PROV 34/STR YEL 10, Rx, Sterile; 00597103112 Provisional CR ART SURF PROV 34/STR YEL 12, Rx, Sterile; 00597103114 Provisional CR ART SURF PROV 34/STR YEL 14, Rx, Sterile; 00597103117 Provisional CR ART SURF PROV 34/STR YEL 17, Rx…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2005-2013·2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00595601201 Femur CR-FLEX OPT FEM B-L Rx Sterile; 00595601202 Femur CR-FLEX OPT FEM B-R Rx Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2030-2013·2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597004109 Articular Surface CR ART SURF 56/STRIPE GREEN 9, Rx, Sterile; 00597004110 Articular Surface CR ART SURF 56/STRIPE GREEN 10, Rx, Sterile; 00597004112 Articular Surface CR ART SURF 56/STRIPE GREEN 12, Rx, Sterile; 00597004114 Articular Surface CR ART SURF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1995-2013·2013-08-28
Blue Belt Technologies Recalls Sterile Monitor Drapes for Navio PFS System
Blue Belt Technologies is recalling sterile monitor drapes used with the Navio PFS system during orthopedic knee surgery because the front section separates from the rest of the drape.
Product
Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO. Product Usage: The intended use of this device is t protect equipment from contamination during a variety of procedures throughout the clinical setting.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2021-2013·2013-08-28
Zimmer NexGen Knee System Recall for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597602010 Articular Surface AC ART SURF 12/PUR 10, Rx, Sterile; 00597602012 Articular Surface AC ART SURF 12/PUR 12, Rx, Sterile; 00597602014 Articular Surface AC ART SURF 12/PUR 14, Rx, Sterile; 00597602017 Articular Surface AC ART SURF 12/PUR 17, Rx, Sterile…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1992-2013·2013-08-28
Stryker Visum 300 Ceiling-mounted Exam Light Recalled for Weld Defect
Stryker Communications is recalling 1,375 Visum 300 Ceiling-mounted Exam Lights due to a potential incomplete final weld on the drop tube flange.
Product
Stryker Visum 300 Ceiling-mounted Exam Light.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2012-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597201333 Femur CR POR SURF HDN FEM CO-NID CML, Rx, Sterile; 00597201334 Femur CR POR SURF HDN FEM CO-NID CMR, Rx, Sterile; 00597201433 Femur CR POR SURF HDN FEM CO-NID DML, Rx, Sterile; 00597201434 Femur CR POR SURF HDN FEM CO-NID DMR, Rx, Sterile; 00597201533…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2003-2013·2013-08-28
Zimmer NexGen Knee System Recall Due to Unapproved Component Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.
Product
65597201101 Femur CR POR FEM HATCP SIZE AML Rx, Sterile; 65597201102 Femur CR POR FEM HATCP SIZE AMR Rx, Sterile; 65597201201 Femur CR POR FEM HATCP SIZE BML Rx, Sterile; 65597201202 Femur CR POR FEM HATCP SIZE BMR Rx, Sterile; Used in total knee arthroplasty…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2027-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting them in unapproved combinations.
Product
00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603112 Articular Surface AC ART SURF 34/STRIPED YEL 12, Rx, Sterile; 00597603110 Articular Surface AC ART SURF 34/STRIPED YEL 10, Rx, Sterile; 00597603110 Articular Surface AC ART SURF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1998-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597001101 Femur CR PRECOAT FEM COMP SIZE AML, Rx, Sterile; 00597001102 Femur CR PRECOAT FEM COMP SIZE AMR, Rx, Sterile; 00597001201 Femur CR PRECOAT FEM COMP SIZE…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2009-2013·2013-08-28
Zimmer Recalls NexGen Knee Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining (CR) Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597001303 Femur CR PRC FEM COMP SIZE CML Rx, Sterile; 00597001304 Femur CR PRC FEM COMP SIZE CMR Rx, Sterile; 00597001403 Femur CR PRC FEM COMP SIZE DML Rx, Sterile; 00597001404 Femur CR PRC FEM COMP SIZE DMR Rx, Sterile; 00597001503 Femur CR PRC FEM COMP…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2008-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
65595201201 Femur CR-FLEX POR HATCP FEM B-L Rx, Sterile; 65595201202 Femur CR-FLEX POR HATCP FEM B-R Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1986-2013·2013-08-28
Medtronic MiniMed Paradigm Reservoirs Recalled for Potential Leaking Risk
Medtronic is recalling specific lots of Paradigm insulin reservoirs because they may leak, potentially delivering less insulin than intended.
Product
Medtronic MiniMed Paradigm Reservoirs, Model No: MMT-326A (1.8mL) and MMT-332A (3.0mL) The model MMT-326A and MMT-332A are syringe type insulin reservoirs intended for use with Medtronic Paradigm series insulin infusion pumps. The two reservoirs are identical except for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1981-2013·2013-08-28
Zimmer Recalls Moore Hip Prosthesis Stems for Sterile Barrier Testing
Zimmer is recalling 1,710 Moore Hip Prosthesis Long Fenestrated Stems to test sterile barrier integrity after a review of historic packaging validations.
Product
Moore Hip Prosthesis Long Fenestrated Stem, several head Diameter, 203 mm Stem length. Used to seat the prosthesis with or without bone cement.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1985-2013·2013-08-28
Sorin Group Recalls Edwards Lifesciences Suction Wands Due to Plastic Particles
Sorin Group is recalling Edwards Lifesciences Suction Wand Model S099B because plastic particles were found inside the packaging pouch.
Product
Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1997-2013·2013-08-28
Beckman Coulter Recalls Hemoccult ICT Fecal Occult Blood Test Kits
Beckman Coulter is recalling 68,116 Hemoccult ICT units due to increased sensitivity at borderline positive levels, which may cause false positives.
Product
Hemoccult ICT (Immunochemical Fecal Occult Blood Test) is a rapid, visually read, qualitative immunochemical chromatographic method for detection of human hemoglobin in fecal samples.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1983-2013·2013-08-28
Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure
Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.
Product
GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1987-2013·2013-08-28
Atrium Medical Recalls PleuraGuide Chest Tube Kits Due to Missing Instructions
Atrium Medical Corporation is recalling 6,516 PleuraGuide Disposable Chest Tube Kits because individual component instructions for use are missing.
Product
PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1996-2013·2013-08-28
Smith & Nephew Recalls Genesis II Knee Trial Inserts Due to Color Error
Smith & Nephew is recalling nine Genesis II Cruciate Retaining Articular Insert trial units because they were produced with the wrong color material.
Product
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-1991-2013·2013-08-28
ConvaTec Flexi-Seal Signal Plus Recalled for Packaging Labeling Error
Convatec Inc. is recalling 22,896 units of Flexi-Seal Signal Plus due to a manufacturing irregularity where lot numbers were duplicated on the packaging.
Product
ConvaTec Flexi-Seal SIGNAL +, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1964-2013·2013-08-28
Philips MobileDiagnost wDR Recalled for Non-Compliant Instructions for Use
Philips Healthcare is recalling MobileDiagnost wDR systems because the Instructions for Use fail to comply with a Federal standard regarding generator value tolerance levels.
Product
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1990-2013·2013-08-28
ConvaTec Flexi-Seal Fecal Management System Recalled for Packaging Error
Convatec is recalling Flexi-Seal Signal Fecal Management Systems because the lot number convention was duplicated on the packaging for certain lots.
Product
ConvaTec Flexi-Seal SIGNAL Fecal Management System, Rx Only Product Usage: For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medication.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1897-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical Corporation is recalling Nova Max Glucose Test Strips due to reports of false abnormally high glucose readings.
Product
Nova Max Glucose Test Strips (50 Count Retail) Catalog Number: 43437 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended…
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1899-2013·2013-08-21
Nova Max Glucose Test Strips Recalled for False High Readings
Nova Biomedical is recalling 721,810 Nova Max Glucose Test Strips because they may produce false abnormally high glucose readings.
Product
Nova Max Glucose Test Strips (10 Count Boxed) Catalog Number: 43590 Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Max Link, BD Logic and Paradigm Link). These monitors are intended to…
Category
Medical Device
Distribution
Distributed nationwide

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37751–37775 of 40449