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

21576–21600 of 27663

HighFDA (Devices)·Z-1700-2016·2016-06-01
Ortho-Clinical Diagnostics Recalls VITROS Total Beta-hCG II Reagent Packs
Ortho-Clinical Diagnostics is recalling specific lots of VITROS Total Beta-hCG II Reagent Packs and Calibrators because they may generate false positive results for hCG levels.
Product
1) VITROS¿ Immunodiagnostic Products Total Beta-hCG II Reagent Pack (Unique Device Identifier No. 10758750002320, 20758750002327) and the 2)VITROS¿ Immunodiagnostic Products Total Beta-hCG II Calibrators (Unique Device Identifier No. 10758750002337, 20758750002334); For…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1782-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 99 boxes of Delicot 4 mm x 50 mm sponges because defective packaging compromises sterility.
Product
American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1769-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 449 boxes of Ray-Cot sponges because defective packaging may compromise sterility.
Product
American Surgical Ray-Cot 1/2" x 3" Ref Number: 60-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1734-2016·2016-06-01
American Surgical Americot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Americot White sponges because defective packaging may compromise sterility. The recall covers 35 boxes distributed worldwide.
Product
American Surgical Americot White 1.5 cm x 5.5 cm Ref Number: 20-31SW Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1776-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 24 boxes of Delicot non-xray sponges because defective packaging compromises sterility.
Product
American Surgical Delicot non-xray 5 mm x 8 mm Ref Number: 63-01 Non X-Ray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1755-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defect
American Surgical Company is recalling 182 boxes of strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Strung 1/2" Ref Number: 30-02 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1767-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 165 boxes distributed worldwide.
Product
American Surgical Ray-Cot 1/2" x 1" Ref Number: 60-07 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1730-2016·2016-06-01
American Surgical Recalls Americot Blue Sponges Due to Packaging Defect
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall affects 4 boxes distributed worldwide.
Product
American Surgical Americot Blue 1/8" x 1/8" Ref Number: 20-19S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1795-2016·2016-06-01
American Surgical Uniqcot Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling 7 boxes of Uniqcot sponges because defective packaging may compromise sterility. The product was distributed worldwide.
Product
American Surgical Uniqcot 1/2" x 1/2" Ref Number: 67-06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1728-2016·2016-06-01
American Surgical Recalls Sponges Due to Packaging Sterility Defect
American Surgical Company is recalling 103 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Americot Blue 1" x 3" Ref Number: 20-10S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1763-2016·2016-06-01
American Surgical Tonsil Sponges Recalled for Packaging Defect Compromising Sterility
American Surgical Company is recalling tonsil sponges due to packaging defects that compromise sterility. The recall covers four boxes distributed worldwide.
Product
American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1749-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility.
Product
American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1827-2016·2016-06-01
Biomet Recalls Orthopedic Instruments Due to Sterile Packaging Seal Defect
Biomet is recalling various trauma and sports medicine instruments and implants because insufficient seal strength on sterile barrier packaging could compromise sterility.
Product
Various trauma and sports medicine instruments and implants. Orthopedic manual surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1773-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 27 boxes distributed worldwide.
Product
American Surgical Ray-Cot 1.5" x 3" Ref Number: 60-22 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1726-2016·2016-06-01
American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Americot Blue sponges because defective packaging compromises sterility. The recall covers 78 boxes distributed worldwide.
Product
American Surgical Americot Blue 1/2" x 1.5" Ref Number: 20-06S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1744-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 23 boxes of Ultracot sponges because defective packaging may compromise sterility. The product is distributed worldwide.
Product
American Surgical Ultracot 13 mm x 60 mm Ref Number: 23-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1735-2016·2016-06-01
American Surgical Recalls Americot Blue Sponges Due to Packaging Defects
American Surgical Company is recalling 37 boxes of Americot Blue sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Americot Blue 1/2" x 2" Ref Number: 20-32S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling specific lots of strung cotton balls because defective packaging may compromise sterility.
Product
American Surgical Cotton Balls-Strung 1.25" Ref Number: 30-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1747-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Defect
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 155 boxes distributed worldwide.
Product
American Surgical Ultracot 20 mm x 60 mm (Glassine) Ref Number: 23-09G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1733-2016·2016-06-01
American Surgical Americot Blue Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 22 boxes of Americot Blue sponges because defective packaging may compromise sterility.
Product
American Surgical Americot Blue 1/4" x 1.5" Ref Number: 20-30S Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1803-2016·2016-06-01
American Surgical Telfa Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling Telfa sponges because defective packaging may compromise sterility. The recall covers 178 boxes distributed worldwide.
Product
American Surgical Telfa 1/2" x 3" Ref Number: 80-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1754-2016·2016-06-01
American Surgical Cotton Balls Recalled for Sterility Compromise
American Surgical Company is recalling 13 boxes of strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Strung 3/8" Ref Number: 30-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1796-2016·2016-06-01
American Surgical Uniqcot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Uniqcot sponges because defective packaging may compromise sterility. The recall covers 4 cases distributed worldwide.
Product
American Surgical Uniqcot 1/2" x 1.5" Ref Number: 67-08 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1743-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Defects Compromising Sterility
American Surgical Company is recalling 32 boxes of Ultracot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Ultracot 9 mm x 50 mm (Glassine) Ref Number: 23-07G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1711-2016·2016-06-01
Limacorporate SMR Glenosphere Impactor/Extractor Recalled for Intra-operative Breakage
Limacorporate is recalling 314 SMR glenosphere impactor/extractor units due to reports of breakage during surgery. The devices were distributed in the US and Australia.
Product
SMR glenosphere impactor/extractor; Used to implant the glenosphere in the SMR Reverse Shoulder replacement.
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

21576–21600 of 27663