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

27301–27325 of 27681

HighFDA (Devices)·Z-2339-2012·2012-09-19
Intuitive Surgical Recalls Tip Covers for Monopolar Curved Scissors
Intuitive Surgical is recalling 11,121 boxes of disposable tip covers for 8mm monopolar curved scissors due to potential sterility compromise.
Product
Tip Cover for 8mm Monopolar Curved Scissors (Hot Shears)Accessory, Disposable, 8mm MCS, Box of 10. The intended use of the Tip Cover Accessory is to provide dielectric insulation over a section of the Monopolar Curved Scissor instrument so that RF energy is only available at…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2361-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2365-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Issues
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-45-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 4.5mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2374-2012·2012-09-19
Omni Life Science Apex Knee System Modular Tibia Augment Recall
Omni Life Science is recalling 182 units of the Apex Knee System Modular Tibia Augment because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 5 x 4mm Ref: KC-54050. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2327-2012·2012-09-19
Bard Foley procedural trays recalled due to incomplete sterile seals
C.R. Bard is recalling 56,694 units of Bard Foley procedural trays because the sterile packaging seals were incomplete.
Product
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2364-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits for Sterility Issues
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-45-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 4.5mm***Use with 20mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2344-2012·2012-09-19
Medtronic Recalls NIM 3.0 Patient Interfaces Due to Signal Loss
Medtronic Xomed is recalling seven NIM 3.0 Patient Interfaces because they may fail to detect electrode signal loss, potentially delaying surgical procedures.
Product
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253210 (Pulse). LABELING: Box Label: REF 8253210 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2346-2012·2012-09-19
Hospira Recalls Sterile Empty Vials Due to Leaking During Filling
Hospira is recalling sterile empty vials and injectors because they may leak during filling and administration. The recall covers products distributed in the US, Canada, Costa Rica, and the Virgin Islands.
Product
Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2371-2012·2012-09-19
Omni Life Science Recalls Apex Knee System Modular Tibia Augments
Omni Life Science is recalling 286 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 2 x 4mm Ref: KC-54020. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2369-2012·2012-09-19
Biosense Webster Recalls CARTO 3 Mapping System Due to Stimulator Hazard
Biosense Webster is recalling 71 CARTO 3 V1.05 systems because a potential hazard may occur when used with Bloom EP Stimulators and other electrophysiology equipment.
Product
CARTO 3 V1.05(FG-5400-00). The CARTO 3 V1.05 System is intended for catheter-based atrial and ventricular mapping. The mapping system allows real-time display of cardiac maps in a number of different formats. Maps may be displayed as cardiac electrical activation maps…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2328-2012·2012-09-19
Custom Medical Specialties Recalls Cysto Pack Due to Missing Microbial Testing
Custom Medical Specialties is recalling CMS-8412-R2 Custom Cysto Packs because the manufacturer did not perform required microbial testing, causing the product to fail finished goods specifications.
Product
CMS-8412-R2 Custom Cysto Pack containing 2 oz. bottle of PVP Prep Solution The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2331-2012·2012-09-19
Custom Medical Specialties Recalls Arthrogram Trays Due to Lack of Microbial Testing
Custom Medical Specialties is recalling CMS-2981-R3 Arthrogram Trays because the manufacturer did not perform microbial testing, causing the product to fail finished goods specifications.
Product
CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution CMS-2981-R3 Arthrogram Tray containing 2 oz. bottle PVP Prep Solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2375-2012·2012-09-19
Omnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
Omni Life Science is recalling 36 units of Apex Knee System Modular Tibia Augments because the sterile packaging may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 6 x 4mm Ref: KC-54060. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2343-2012·2012-09-19
Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss
Medtronic Xomed is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss from the electrode.
Product
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces REF 8253410 (Neuro). LABELING: Box Label: REF 8253410 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2348-2012·2012-09-19
Terumo Sarns Modular Perfusion System 8000 Safety Monitor Recall
Terumo is recalling eight Sarns Modular Perfusion System 8000 safety monitors due to an underrated circuit breaker that may cause the device to trip off.
Product
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2342-2012·2012-09-19
Medtronic NIM 3.0 Patient Interfaces Recalled for Signal Loss
Medtronic is recalling NIM 3.0 Patient Interfaces due to a trend of open channel conditions causing signal loss and potential surgical delays.
Product
Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 Patient Interfaces 8253200 (Response) LABELING: Box Label: REF 8253200 x1***NIM-Response 3.0 Patient Interface***Medtronic Xomed, Inc., 6743 Southpoint Drive North Jacksonville, FL 32216-0980…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2363-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits Due to Sterility Concerns
Exactech is recalling two Novation Modular Drill Bits because they were reported to have been used in a non-sterile condition.
Product
REF 101-05-40***NOVATION MODULAR DRILL BIT LENGTH: 40mm, DIAMETER 3.2mm***Use with 40mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2334-2012·2012-09-19
JK Products Recalls Sun|Dash Radius 252 Tanning Systems Due to Wiring Short
JK Products & Services is recalling 1,948 Sun|Dash Radius 252 tanning systems because a door cord failure can cause a short in the wiring.
Product
SUN|DASH RADIUS 252 tanning system; 52 lamps, Ultraviolet Radiation. The device is intended to be used for tanning of the human skin.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2373-2012·2012-09-19
Omni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
Omni Life Science is recalling 270 Apex Knee System Modular Tibia Augments because the sterile pouches may breach, compromising sterility.
Product
Omnilife Science Apex Knee System Modular Tibia Augment, Size 4 x 4mm Ref: KC-54040. The Apex Knee System is intended for use as a primary or revision total knee replacement.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2333-2012·2012-09-19
Aesculap S4 Polyaxial Screws Recalled for Potential Channel Tolerance Defect
Aesculap Implant Systems LLC is recalling S4 Element 4.5mm Polyaxial Screws because the screw channel may be out of tolerance, potentially preventing the screw head from locking to the bone.
Product
Aesculap S4 Element 4.5mm Polyaxial Screws (ST240T, ST241T, ST242T, ST243T, ST244T, and ST245T). The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2256-2012·2012-09-19
GE Healthcare Recalls Optima XR200amx Mobile X-Ray Units Due to Software Issue
GE Healthcare is recalling 254 Optima XR200amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.
Product
Optima XR200amx. Mobile general purpose radiographic imaging of the human head and body.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2377-2012·2012-09-19
Capsule Neuron Docking Station Recalled for Potential Connection Loss
Capsule Tech Inc. is recalling 12,448 Capsule Neuron Docking Stations because they may lose connection, causing data loss or power interruption to the bedside device.
Product
Capsule Neuron Docking Station, a component in the DataCaptor Connectivity System Catalog Number DC-NU-DS-CK The Capsule Neuron Docking Station is a component in the DataCaptor Connectivity System. The Capsule Neuron Docking Station provides connection for the Capsule Neuron…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2329-2012·2012-09-19
Custom Medical Specialties Recalls CMS-2890 Needle Local Trays
Custom Medical Specialties is recalling 16 cases of CMS-2890 Custom Needle Local Trays because the manufacturer lacked microbial testing and the product did not meet finished goods specifications.
Product
CMS-2890 Custom Needle Local Tray containing PVP Prep Pad The PV contained in the kit is used in skin prep
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2255-2012·2012-09-19
GE Healthcare Recalls Optima XR220amx Mobile X-Ray Units Due to Software Issue
GE Healthcare is recalling 254 Optima XR220amx mobile X-ray units in the US because a software defect allows exposures without displaying technique factors.
Product
Optima XR220amx Mobile general purpose radiographic imaging of the human head and body.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2362-2012·2012-09-19
Exactech Recalls Novation Modular Drill Bits for Non-Sterile Condition
Exactech is recalling two Novation Modular Drill Bits after they were reported to have been used in a non-sterile condition.
Product
REF 101-05-30***NOVATION MODULAR DRILL BIT LENGTH: 30mm, DIAMETER 3.2mm***Use with 30mm Screw***STERILE***EXACTECH 2320 NW 56th Court, Gainesville, FL 32653***. To assist the surgeon in the implantation of Novation Hip system components in according to a conventional…
Category
Medical Device
Distribution
Distributed nationwide

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27301–27325 of 27681