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

38251–38275 of 40449

SevereFDA (Devices)·Z-1452-2013·2013-06-12
Symbios Recalls GoPump Infusion Pumps Due to High Flow Rates
Symbios Medical Products is voluntarily recalling GoPump infusion pumps and kits due to reports of excessively high flow rates.
Product
Part 510031 Disposable Single Infusion Pump, quantity Includes... TOTAL VOLUME: 150mL, 2 mL/hr continuous Delivery Time : App. 72 hrs when filled to capacity Sterile EO... found in the following GoPump Kits: GoPump Kit 510042, w/ Epidural Catheter GoPump Kit…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1516-2013·2013-06-12
American Optisurgical Recalls TX1 Tissue Removal System Consoles
American Optisurgical is recalling 194 TX1 Tissue Removal System Consoles due to a defect in the overheating protection circuit that may cause the device to lose power during use.
Product
American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
Category
Medical Device
Distribution
31 states
HighFDA (Devices)·Z-1506-2013·2013-06-12
Alcon Recalls Constellation Pneumatic Handpieces Due to Tip Dislodgement Risk
Alcon is removing 8,455 Constellation Pneumatic Handpieces from the market because forceps or scissors tips may dislodge if not attached according to instructions.
Product
The Constellation Vision System Pneumatic Handpiece. Indicated for both anterior and posterior segment opthalmic surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1483-2013·2013-06-12
Zimmer Air Dermatome Recalled for Broken Planetary Gear Teeth
Zimmer Surgical Inc is recalling 84 units of the Zimmer Air Dermatome because broken planetary gear teeth may cause the device to fail during surgery.
Product
The Zimmer Air Dermatome, REF 00- 8801- 001- 00 , Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2013·2013-06-12
I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Tray Recall
I-Flow LLC is voluntarily removing 450 units of the ON-Q Pain Relief System T-Block Needle/Catheter Tray because the devices may have malfunctioned.
Product
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Tray, Model #TBTB1089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1508-2013·2013-06-12
Cordis Recalls FLEXSTENT Stent Systems Due to Pouch Integrity Issues
Cordis is recalling 784 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
Product
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1505-2013·2013-06-12
American Optisurgical Recalls ChloraPrep Applicators Due to Seal Defect
American Optisurgical is recalling ChloraPrep Hi-Lite Orange 3mL Applicators because an incomplete seal on the packaging may have compromised sterility assurance.
Product
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1510-2013·2013-06-12
Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects
Cordis Corporation is recalling 250 units of FLEXSTENT stent systems because holes or tears can form in the protective pouches.
Product
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1504-2013·2013-06-12
Stryker Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T5 zipper Toga surgical drapes because accelerated aging tests indicate a potential breach in the sterile barrier within the second and third year of shelf life.
Product
Stryker Instruments 0400-850-100 T5 zipper Toga with Peel Away, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1501-2013·2013-06-12
Stryker T4 Toga Recall Due to Potential Sterile Barrier Breach
Stryker is recalling T4 Toga sterile surgical gowns because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-840-000 T4 Toga, Zipper, Large, Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1439-2013·2013-06-12
Gyrus Acmi Recalls Disposable Myringotomy Knives Due to Sterility Concerns
Gyrus Acmi is recalling disposable myringotomy knives because they may lack sterility assurance. The affected units were distributed in the US, Canada, and the UK.
Product
GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1471-2013·2013-06-12
FDA Recalls Versaport Bladeless Optical Fixation Cannulas Due to Seal Disengagement
The FDA is recalling Versaport Bladeless Optical Fixation Cannulas because seals may disengage, potentially causing components to enter the patient's cavity.
Product
Versaport Bladeless Optical Fixation Cannula - 5mm Short Product Code: ONBFCA5SH The Versaport" Bladeless Optical 5mm trocars are intended for use in a variety of gynecologic, general, thoracic and urologic endoscopic procedures to create and maintain a port of entry.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1511-2013·2013-06-12
Cordis FLEXSTENT Stent System Recalled for Pouch Integrity Defects
Cordis Corporation is recalling 310 FLEXSTENT stent systems because holes or tears can form in the protective pouches, potentially compromising the device.
Product
FLEXSTENT Femoropopliteal Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT¿ Femoropopliteal SES clinical product is indicated for treatment of atherosclerotic de novo native superficial femoral artery lesions and proximal popliteal lesions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2013·2013-06-12
GE Healthcare Recalls CO2 Absorbent Canisters for Anesthesia Systems
GE Healthcare is recalling 800 reusable CO2 absorbent canisters used with anesthesia systems because they may not seal properly.
Product
Canister: CO2 canister with GE part numbers 1407-3200-000, 1407-7004-000, or M1084850. Intended to provide general inhalation anesthesia and ventilatory support.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1475-2013·2013-06-12
Hill-Rom Recalls SlingBar Wide 670 Patient Lifts Due to Impalement Risk
Hill-Rom is recalling 412 SlingBar Wide 670 patient lifts because a retrospective review found a potential for impalement if a person falls onto the hooks.
Product
SlingBar Wide 670. Designed to meet the needs for lifting humans.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1489-2013·2013-06-12
Stryker T4 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling T4 Pullover Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-710-000 T4 Pullover Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1485-2013·2013-06-12
Zimmer Air Dermatome II Recalled Due to Broken Planetary Gear Teeth
Zimmer Surgical Inc is recalling 13 units of the Zimmer Air Dermatome II handpiece because broken planetary gear teeth may cause the device to fail or operate intermittently during surgery.
Product
Zimmer Air Dermatome II, REF 00-8851-001-01 handpiece, w/o hose, Rx, non-sterile grafting instruments intended to provide variable graft thickness and width capabilities.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1507-2013·2013-06-12
Cordis Recalls FLEXSTENT Biliary Stents Due to Pouch Defects
Cordis Corporation is recalling 23 units of FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.
Product
FLEXSTENT Biliary Self-Expanding Stent System. Product Usage: The FSS FLEXSTENT Biliary SES product is indicated for use in the palliation of malignant strictures in the biliary tree.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1482-2013·2013-06-12
SpineFrontier Recalls Straight Impactor Devices Due to Handle Plate Breakage
SpineFrontier, Inc. is recalling 10 Straight Impactor - Dorado IBC devices because the impactor plate on the handle broke off during use.
Product
Straight Impactor - Dorado IBC, Part Number: SI02140. The device is used to position implants after they have been inserted into the disc space during implantation of intervertebral body fusion devices.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1495-2013·2013-06-12
Stryker T4 Zipper Toga Recall for Potential Sterile Barrier Breach
Stryker is recalling T4 Zipper Togas because accelerated aging tests indicate a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-810-000 T4 Zipper Toga (S/M) Sterile, EO; single use; Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1481-2013·2013-06-12
Philips Recalls BrightView SPECT Gamma Cameras Due to Mechanical Failure
Philips Medical Systems is recalling 505 BrightView SPECT gamma cameras worldwide after a report of unexpected detector motion caused by a mechanical assembly failure.
Product
BrightView SPECT gamma camera for Emission Computed Tomography, Philips Medical Systems, Cleveland, OH 44143 BrightView SPECT is a gamma camera designed for single or dual detector nuclear imaging accommodating a broad range of emission computed tomography Emission Computed…
Category
Medical Device
Distribution
44 states
HighFDA (Devices)·Z-1488-2013·2013-06-12
Berchtold Recalls Hand Controls for Operon Surgical Tables
Berchtold Corp. is recalling 3,763 hand controls for Operon surgical tables due to reports of unintended movements.
Product
Hand Controls for Operon D750, D752, D760, D820 and D850 The hand controls are used to operate OPERON surgical tables
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1491-2013·2013-06-12
Stryker T5 Pullover Toga Recalled for Potential Sterile Barrier Breach
Stryker is recalling 1,980 units of T5 Pullover Togas due to accelerated aging tests indicating a potential breach in the sterile barrier packaging.
Product
Stryker Instruments 0400-720-000S5 T5 Pullover Toga w/Peel Away, Sterile, EO; single use. Product Usage: Protection System and are intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1369-2013·2013-06-12
Shimadzu Mobile X-ray Systems Recalled for Loose Internal Screws
Shimadzu Medical Systems is recalling 200 Mobile DaRt Evolution X-ray systems due to a potential risk of internal screws becoming loose.
Product
Shimadzu Corporation - Mobile DaRt Evolution This device is a mobile X-ray system in order to take general radiography of patients in the hospital who cannot move and/or of out patients in emergency .
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2013·2013-06-12
I-Flow ON-Q Pain Relief System T-Block Needle/Catheter Kit Recalled
I-Flow LLC is voluntarily removing 75 units of the ON-Q Pain Relief System T-Block Needle/Catheter Kit because they may have potentially malfunctioned.
Product
I-Flow ON-Q Pain Relief System, T-Block Needle/Catheter Kit, Model #TB089T The intended use of each component in the finished final trays is consistent with the intended use of the component stated in the respective 510(k) submission.
Category
Medical Device
Distribution
Distributed nationwide

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38251–38275 of 40449