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 deaths or serious injuries are reported, 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

4876–4900 of 5038

SevereFDA (Devices)·Z-0438-2013·2012-12-05
Extremity Medical Recalls IO FiX X-Post Reamer Due to Intraoperative Breakage
Extremity Medical LLC is recalling 156 units of the IO FiX X-Post Reamer after reports of the device breaking during surgery.
Product
IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.
Category
Medical Device
Distribution
22 states
SevereFDA (Devices)·Z-0349-2013·2012-11-28
NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0358-2013·2012-11-28
NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0359-2013·2012-11-28
NuVasive 6.5mm Cannulated Screw Shank Recall for Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0357-2013·2012-11-28
NuVasive Recalls 6.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 40mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0348-2013·2012-11-28
NuVasive Recalls 240 Screw Tulip Implants Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.25mm Screw Tulip implants because the tulip portion can disengage from the shank after implantation.
Product
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0369-2013·2012-11-28
NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 4.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0365-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0364-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 45mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0297-2013·2012-11-28
Biomet 3i Recalls OSSEOTITE Dental Implants Due to Shallow Hex Depth
Biomet 3i is recalling 191 OSSEOTITE dental implants because a manufacturing defect makes the internal hex too shallow, which may prevent the driver or abutment from fully engaging.
Product
Product is Full OSSEOTITE 2 Tapered Certain Implant, Model Number XIFNT413, and size 4 x 13 mm. The product is sterile. Product provides a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utiliz
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0362-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 35mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0378-2013·2012-11-28
NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0368-2013·2012-11-28
NuVasive Recalls 4.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 4.5mm x 35mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0373-2013·2012-11-28
NuVasive Recalls 6.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0354-2013·2012-11-28
NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0353-2013·2012-11-28
NuVasive Recalls 5.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 50mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0363-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 40mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.
Product
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0361-2013·2012-11-28
NuVasive Recalls 7.5mm Cannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 30mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0375-2013·2012-11-28
NuVasive Recalls 6.5mm Noncannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 50mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0367-2013·2012-11-28
NuVasive Recalls 240 Screw Tulip Medical Devices for Disengagement Risk
NuVasive Inc is recalling 240 units of Screw Tulip, 5.5mm Rod devices because the tulip portion can disengage from the shank after implantation.
Product
Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0409-2013·2012-11-28
KCI RotoRest Delta Therapy System Head Pack Recalled for Skin Injury
KCI USA is voluntarily recalling 282 RotoRest Delta Therapy System head packs due to reports of skin breakdown and pressure ulcers.
Product
RotoRest Delta Kinetic Therapy System INDICATIONS: Treatment and prevention of pulmonary complications as a result of immobility, Thoracic or lumbar fracture, Cervical traction, Skeletal traction
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0360-2013·2012-11-28
NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 55mm Cannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0355-2013·2012-11-28
NuVasive Recalls 6.5mm Cannulated Screw Shank Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 6.5mm x 30mm Cannulated Screw Shanks because the tulip portion may disengage from the shank after implantation.
Product
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0376-2013·2012-11-28
NuVasive Recalls 7.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 7.5mm x 40mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0371-2013·2012-11-28
NuVasive Recalls 5.5mm Noncannulated Screw Shanks Due to Disengagement Risk
NuVasive Inc is recalling 240 units of 5.5mm x 45mm Noncannulated Screw Shanks because the tulip portion can disengage from the shank after implantation.
Product
5.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
Category
Medical Device
Distribution
Distributed nationwide

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4876–4900 of 5038