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

37626–37650 of 40325

HighFDA (Devices)·Z-2024-2013·2013-08-28
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
00597003109 Articular Surface CR ART SURF 34/STRIPE YEL 9, Rx, Sterile; 00597003110 Articular Surface CR ART SURF 34/STRIPE YEL 10, Rx, Sterile; 00597003112 Articular Surface CR ART SURF 34/STRIPE YEL 12, Rx, Sterile; 00597003114 Articular Surface CR ART SURF 34/STRIPE…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2044-2013·2013-08-28
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.
Product
00597104110 Provisional CR ART SURF PROV 56/STR GRN 10, Rx, Sterile; 00597104112 Provisional CR ART SURF PROV 56/STR GRN 12, Rx, Sterile; 00597104114 Provisional CR ART SURF PROV 56/STR GRN 14, Rx, Sterile; 00597104117 Provisional CR ART SURF PROV 56/STR GRN 17, Rx…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2018-2013·2013-08-28
Zimmer NexGen Knee Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining knee components because surgeons are implanting them in unapproved combinations.
Product
00597002009 Articular Surface CR ART SURF 12/PURPLE 9, Rx, Sterile; 00597002010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597002012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597002014 Articular Surface CR ART SURF 12/PURPLE 14, Rx…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1999-2013·2013-08-28
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
00597001131 Femur CR PRC SURF HDN FEM CO-NID AML, Rx, Sterile; 00597001132 Femur CR PRC SURF HDN FEM CO-NID AMR, Rx, Sterile; 00597001231 Femur CR PRC SURF HDN FEM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2011-2013·2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597201303 Femur CR POR FM COMP SIZE CML Rx, Sterile; 00597201304 Femur CR POR FM COMP SIZE CMR Rx, Sterile; 00597201403 Femur CR POR FM COMP SIZE DML Rx, Sterile; 00597201404 Femur CR POR FM COMP SIZE DMR Rx, Sterile; 00597201503 Femur CR POR FM COMP SIZE EML…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2029-2013·2013-08-28
Zimmer NexGen Knee Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen Cruciate Retaining knee components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
90595204117 Articular Surface XLPE CR ART SURF AE56/STGRN 17, Rx, Sterile; 90595204120 Articular Surface XLPE CR ART SURF AE56/STGRN 20, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2006-2013·2013-08-28
Zimmer Recalls NexGen Knee System Components Due to 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
00595001201 Femur CR-FLEX PCT FEM B-L Rx, Sterile; 00595001202 Femur CR-FLEX PCT 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-1967-2013·2013-08-28
GE Healthcare Recalls Discovery NM/CT 570c Systems for Scanning Error
GE Healthcare is recalling 10 Discovery NM/CT 570c systems in Connecticut after an incident where the wrong part of a patient's body was scanned during a CT exam.
Product
The Discovery NM/CT 570c CT Standalone Scan The Discovery NM/CT 570c hybrid system is a combination of a cardiac dedicated nuclear imaging subsystem and LightSpeed GE CT subsystem. This system is intended for cardiac Nuclear Medicine (NM) diagnostic imaging applications…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2020-2013·2013-08-28
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.
Product
00597202009 Articular Surface CR ART SURF 12/PURPLE 09, Rx, Sterile; 00597202010 Articular Surface CR ART SURF 12/PURPLE 10, Rx, Sterile; 00597202012 Articular Surface CR ART SURF 12/PURPLE 12, Rx, Sterile; 00597202014 Articular Surface CR ART SURF 12/PURPLE 14, Rx…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1979-2013·2013-08-28
Boston Scientific Recalls ENERGEN DR ICD Due to Test Artifacts
Boston Scientific is recalling one ENERGEN DR ICD (Model E143) because test artifacts related to shock charge time require further investigation.
Product
Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2040-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen Knee System components because surgeons are implanting them in unapproved combinations, creating a risk of improper fit.
Product
00597503110 Provisional AC ARTSURF PROV 34/STRIPE YEL10, Rx, Sterile; 00597503112 Provisional AC ARTSURF PROV 34/STRIPE YEL12, Rx, Sterile; 00597503114 Provisional AC ARTSURF PROV 34/STRIPE YEL14, Rx, Sterile; 00597503117 Provisional AC ARTSURF PROV 34/STRIPE YEL17…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2013·2013-08-28
GE Healthcare Precision 500D X-Ray Systems Recalled for Monitor Suspension Defect
GE Healthcare is recalling Precision 500D systems because a locking nut on the overhead video monitor suspension may loosen, posing a risk of impact.
Product
GE Healthcare, Precision 500D Product Usage: The Precision 500D is designed to perform radiographic and fluoroscopic x-ray examinations.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2019-2013·2013-08-28
Zimmer NexGen Knee System Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved micro and standard combinations.
Product
90597002009 Articular Surface CR ART SURF 12/PURPLE 09MM, Rx, Sterile; 90597002010 Articular Surface CR ART SURF 12/PURPLE 10MM, Rx, Sterile; 90597002012 Articular Surface CR ART SURF 12/PURPLE 12MM, Rx, Sterile; 90597002014 Articular Surface CR ART SURF 12/PURPLE 14MM…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2015-2013·2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer is recalling NexGen CR Complete Knee System components because surgeons are implanting them in unapproved combinations, mixing micro and standard parts.
Product
00597206126 Patella ALL POLY PAT COMP MICRO 26DIA, Rx, Sterile; 00597206129 Patella ALL POLY PAT COMP MICRO 29DIA, Rx, Sterile; 00597206132 Patella ALL POLY PAT COMP MICRO 32DIA, Rx, Sterile; 00597206135 Patella ALL POLY PAT COMP MICRO 35DIA, Rx, Sterile; Used in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2036-2013·2013-08-28
Zimmer NexGen Knee Implant Components Recalled for Unapproved Combinations
Zimmer, Inc. is recalling NexGen CR Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00598706201 Provisional CRA FEM PROV/CUT GDE SZ BML, Rx, Sterile; 00598706202 Provisional CRA FEM PROV/CUT GDE SZ BMR, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2033-2013·2013-08-28
Zimmer NexGen Knee System Recalled for Unapproved Component Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Complete Knee System components because surgeons are implanting unapproved combinations of micro and standard parts.
Product
00597604110 Articular Surface AC ART SURF 56/STRIPED GRN 10, Rx, Sterile; 00597604112 Articular Surface AC ART SURF 56/STRIPED GRN 12, Rx, Sterile; 00597604114 Articular Surface AC ART SURF 56/STRIPED GRN 14, Rx, Sterile; 00597604117 Articular Surface AC ART SURF…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1984-2013·2013-08-28
Medicel nanoPOINT Injector System Recalled for Potential Sterility Compromise
Medicel Ag is recalling one lot of nanoPOINT Injector Systems because damaged Tyvek lids may have compromised the sterile barrier.
Product
Product Name: nanoPOINT Injector System, item number 37-0000-08. Intended to fold and insert a STAAR Surgical Collamer¿ nanoFLEX or Afinity IOLs, through surgical procedure in a human eye.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2038-2013·2013-08-28
Zimmer Recalls NexGen Knee System Components Due to Unapproved Combinations
Zimmer, Inc. is recalling NexGen Cruciate Retaining Knee System components because surgeons are implanting them in unapproved combinations.
Product
00597106126 Provisional MIC POROUS PAT PROV 26MMX10MM, Rx, Sterile; 00597106129 Provisional MIC POROUS PAT PROV 29MMX10MM, Rx, Sterile; 00597106132 Provisional MIC POROUS PAT PROV 32MMX10MM, Rx, Sterile; 00597106135 Provisional MIC POROUS PAT PROV 35MMX10MM, Rx…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1988-2013·2013-08-28
Aspen Surgical Recalls Wound Closures Due to Sterility Concerns
Aspen Surgical Products is recalling reinforced wound closure strips because FDA sampling indicated the product may not be sterile, posing a risk of infection.
Product
Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile…
Category
Medical Device
Distribution
Distributed nationwide
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

How to read this listing

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37626–37650 of 40325