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

39226–39250 of 40356

ModerateFDA (Devices)·Z-0446-2013·2012-12-05
Iradimed Recalls MRidium Series 1000 MR Infusion Sets Due to Specification Defect
Iradimed Corporation is recalling 719 MRidium Series 1000 MR Infusion Sets because a section of the device does not meet specifications.
Product
The brand name is MRidium Series 1000 MR Infusion Sets, Type 1058 MR IV Extension Set, Lot Code LBG001. The generic name is infusion administration set. Labeling indicates ~10 ml, Latex-free Infusion Set with Needle-free Port, One injection Port. Device is single use only…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0448-2013·2012-12-05
GE Healthcare Recalls Mobile X-ray Systems Due to Software Issue
GE Healthcare is recalling Optima XR220amx and XR200amx mobile X-ray systems due to a software issue on the product interface.
Product
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0445-2013·2012-12-05
Diamedix Recalls Is-anti-Sm Test Kits Due to Control Failure
Diamedix Corporation is recalling 65 Is-anti-Sm Test Kits because the positive control recovered high out of specification.
Product
The Is-anti-Sm test kits****Catalog No: 720-240*** Product Usage: The Diamedix Is-anti-Sm Test Kit is an EIA procedure intended for the detection and semi-quantitation of antibodies against the Sm antigen in serum as an aid in the diagnosis of autoimmune disease. The results…
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-0291-2013·2012-11-28
Mindray A5 Anesthesia Delivery System Recalled for Potential System Leak
Mindray is recalling A5 Anesthesia Delivery Systems due to a potential system leak caused by a carbon dioxide absorber canister gasket issue.
Product
Mindray A5 Anesthesia Delivery System Manufactured in China for Mindray DS USA Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 This is a device used to administer to a patient continuously or intermittently a general inhalation anesthetic and to maintain a patient's…
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-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-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
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-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-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-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-0292-2013·2012-11-28
Ethicon Surgiflo Hemostatic Matrix Kit Packaging Defect Recall
Ethicon is recalling Surgiflo Hemostatic Matrix Kits due to a packaging defect that could breach the Tyvek pouch.
Product
ETHICON SURGIFLO HEMOSTATIC MATRIX KIT Plus FlexTip with Thrombin distributed by ETHICON ETHICON Inc. Somerville, NJ 08876 USA Ref 2993 SURGIFLO Hemostatic Matrix, mixed with sterile saline or thrombin solution, is indicated for surgical procedures (except…
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-0293-2013·2012-11-28
Ethicon Recalls Surgiflo Hemostatic Matrix Kits Due to Packaging Defect
Ethicon is recalling Surgiflo Hemostatic Matrix kits because a potential cut in the packaging could breach the sterile Tyvek pouch.
Product
ETHICON SURGIFLO HEMOSTATIC MATRIX Distributed by ETHICON ETHICON, Inc. Somerville, NJ 08876, USA SURGIFLO Hemostatic Matrix is a topical absorbable hemostat consisting of a flowable gelatin matrix (paste). This kit also contains components necessary for preparing and…
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-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-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-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…
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-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-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-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-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-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

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39226–39250 of 40356