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

38951–38975 of 40449

ModerateFDA (Devices)·Z-0800-2013·2013-02-20
Bacterin Recalls Expired Osteoselect Demineralized Bone Matrix Putty
Bacterin International is recalling expired Osteoselect Demineralized Bone Matrix Putty shipped to customers in Texas, Georgia, and California.
Product
Bacterin International, Inc., Osteoselect Demineralized Bone Matrix DMB Putty; Graft ID# B090056-664 Donor# B090056 2.5cc Expiration Date: 12/25/2011; LBL 210-0010-1 REV: 040109; and Graft ID# B090056-675. Bone void filler for voids or gaps in bone. Indicated for treatment…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0812-2013·2013-02-20
Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error
Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.
Product
Ultradent Products, Chromaclone PVS, Fast Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5013, Lot No. B7DS3, Used in prosthodontics.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0811-2013·2013-02-20
Ultradent Chromaclone PVS Impression Material Recalled for Packaging Error
Ultradent Products is recalling specific lots of Chromaclone PVS impression material due to incorrect packaging of regular and fast set cartridges.
Product
Ultradent Products, Chromaclone PVS, Regular Set heavy body, Bubble Gum Flavor, 50 ml, Impression Material, Part No. 5012, Lot No. B7PPC. Used in prosthodontics.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0777-2013·2013-02-13
Winco Premier Lifecare Recliner 5400 Recalled for Fire Safety Non-Compliance
Winco Mfg. is recalling 95 Premier Lifecare Recliner 5400 units because their foam and vinyl do not meet California's TB 133 fire protection standards.
Product
PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0770-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity levels below the specified range. The recall includes units manufactured since March 2009 and was expanded in October 2012.
Product
Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0772-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Specification Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shell Spiked units because some may have porosity levels below the required specification.
Product
Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0797-2013·2013-02-13
Custom Breast Biopsy Tray Recalled for Potential Particulate Matter
Custom Healthcare Systems is recalling breast biopsy trays because they may contain particulate matter in the included sodium chloride.
Product
Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0776-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells with Holes because some units may have porosity below the specified range.
Product
Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0778-2013·2013-02-13
Winco Premier Care Recliners Recalled for Fire Safety Non-Compliance
Winco Mfg. is recalling 95 Premier Care Recliners because the foam and vinyl chemicals do not consistently meet California's TB 133 fire protection mandate.
Product
PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0780-2013·2013-02-13
Winco Medical Recliners Recalled for Fire Protection Non-Compliance
Winco Mfg. is recalling 95 medical recliners because their foam and vinyl do not meet California fire safety standards.
Product
Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0769-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells for Porosity Defect
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells because some units have porosity below the specified range. The recall includes 275,952 units distributed worldwide.
Product
Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0773-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defect
Zimmer, Inc. is recalling Trilogy Acetabular Shells because some units may have porosity below the specified range, potentially affecting the device's performance.
Product
Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0794-2013·2013-02-13
Allergen Medical Recalls SeriScaffold Surgical Scaffold Due to Sterility Concerns
Allergen Medical is recalling SeriScaffold Surgical Scaffold units because the outer packaging seal may be compromised, potentially compromising sterility.
Product
SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures.
Category
Medical Device
Distribution
13 states
HighFDA (Devices)·Z-0775-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells with Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular Shells with holes because some units have porosity below the specified range, which may affect bone ingrowth.
Product
Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0781-2013·2013-02-13
Synthes Spine Drill Bit Recalled for Potential Drill Stop Slippage
Synthes USA is recalling 63 units of 2.5mm drill bits for the Vectra Spine System due to a potential drill stop slippage hazard.
Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0782-2013·2013-02-13
Synthes Spine Vectra Adjustable Drill Stop Recalled for Slip Risk
Synthes USA is recalling 48 units of the Spine Vectra Adjustable Drill Stop because the device may slip on the drill bit, posing a risk of adverse events during surgery.
Product
Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0766-2013·2013-02-13
Tobii P10 Battery Box Recalled for Smoke and Chemical Smell During Recharging
Tobii Assistive Technology is recalling 483 P10 battery boxes that malfunctioned while recharging, producing smoke and a chemical smell.
Product
P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0774-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy Acetabular AB Shells because some units have porosity levels below the required specification.
Product
Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0796-2013·2013-02-13
Custom Breast Biopsy Tray Recalled for Potential Particulate Matter
Custom Healthcare Systems is recalling 80 breast biopsy trays because they may contain particulate matter in the pharmaceuticals used for injection.
Product
Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0779-2013·2013-02-13
Winco Cozy Comfort Premier Recliner 5580 Recalled for Fire Safety Non-Compliance
Winco Mfg. is recalling 95 Cozy Comfort Premier Recliner 5580 units because the foam and vinyl chemicals do not consistently meet California TB 133 fire protection mandates.
Product
Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0783-2013·2013-02-13
Anspach Effort Recalls Bearing Sleeve Devices Due to Metal Fragment Risk
The Anspach Effort, Inc. is recalling 8 MA-15C Bearing Sleeve devices distributed in Massachusetts. The recall addresses a risk of metal fragments remaining in the surgical site.
Product
Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0791-2013·2013-02-13
Medacta Quadra Trial Broach size 0 recalled due to tip breakage
Medacta USA Inc. is recalling 26 units of the Quadra Trial Broach size 0 because the tip broke during surgery.
Product
Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0784-2013·2013-02-13
Lansinoh Thera Pearl Breast Therapy Hot and Cold Packs Recalled for Overheating Risk
Lansinoh is recalling Thera Pearl 3-in-1 Breast Therapy packs because incorrect Spanish heating instructions may cause the product to overheat.
Product
THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0771-2013·2013-02-13
Zimmer Recalls Trilogy Acetabular Shells Due to Porosity Defects
Zimmer, Inc. is recalling Trilogy F/M Acetabular Shells with Uni-Hole because some units have porosity below the specified range.
Product
Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0785-2013·2013-02-13
Invacare Solara 3G Manual Wheelchair Recalled for Brake Failure Risk
Invacare is recalling three Solara 3G custom manual wheelchairs because the wheels may rotate freely despite the hub brake being engaged.
Product
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position.
Category
Medical Device
Distribution
Distributed nationwide

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38951–38975 of 40449