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

32901–32925 of 40449

HighFDA (Devices)·Z-1811-2015·2015-06-24
CareFusion Alaris PC Unit Infusion Pump Software Recall
CareFusion 303, Inc. is recalling 63 Alaris PC unit model 8015 infusion pumps due to a software defect that may allow infusions to start outside hospital-established limits.
Product
Alaris PC unit model 8015, Infusion pump. software version 9.17 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System. The software is embedded in the Alaris PC unit.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1693-2015·2015-06-24
Neusoft NeuViz 64 CT Scanner Recalled for Teflon Compensator Failure
Neusoft Medical System Co is recalling NeuViz 64 CT scanners because the Teflon A-plane compensator degrades under X-ray exposure, causing premature failure and image artifacts.
Product
Neusoft NeuViz 64 Multi-slice CT Scanner System
Category
Medical Device
Distribution
5 states
HighFDA (Devices)·Z-1816-2015·2015-06-24
BD Viper LT System Recalled for Potential False Positive Diagnostic Results
Becton Dickinson is recalling seven BD Viper LT Systems due to the potential for false positive Chlamydia and Gonorrhea test results.
Product
BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1803-2015·2015-06-24
Beaver-Visitec Recalls Ophthalmic Procedure Kits with Defective Gloves
Beaver-Visitec is recalling 384 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
Product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584648 Ophthalmic surgical kits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1817-2015·2015-06-24
Boston Scientific Recalls CLEARSIGN II Amplifiers Due to ECG Signal Interference
Boston Scientific is recalling 43 CLEARSIGN II Amplifiers because blood pressure channel usage can cause ECG signals to become uninterpretable.
Product
CLEARSIGN II Amplifier for LABSYSTEM PRO EP Recording System, 120 channels, using firmware version 2.08. The channel numbers in the amplifier are as follows: Material number: H30120020210 - 40 Channel CLEARSIGN II Amplifier, catalog number 2002021; Material number…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1807-2015·2015-06-24
Philips Q-Station Ultrasound Software Recalled for Data Integrity Issues
Philips is recalling Q-Station ultrasound software because patient measurements may be incorrectly appended to other patients' studies.
Product
Philips Ultrasound, Model Q-Station, with software version 3 or higher, Catalog number: 795088; Part Number: 989605382391 Q-Station is application software intended to manage, view, analyze, and report qualitative and quantitative image data from ultrasound exams. It is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1805-2015·2015-06-24
Beaver-Visitec Recalls Ophthalmic Kits with Defective Sterile Gloves
Beaver-Visitec is recalling 214 ophthalmic procedure kits because the included Devon Light Gloves may have holes or slits that compromise sterility.
Product
BVI Custom Eyes¿ Ophthalmic Procedure Kits with the component -Devon Light Glove Part Number: 584671 Ophthalmic surgical kits
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1794-2015·2015-06-24
Medtronic Passive Planar Blunt Probe Recalled Due to Sharp Tip Defect
Medtronic is recalling 18 Passive Planar Blunt Probes because they were manufactured with sharp tips instead of blunt tips. The devices are used in navigated surgery.
Product
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1795-2015·2015-06-24
Neuro Kinetics Recalls I-Portal NOTC and VNG Devices Due to Malfunction
Neuro Kinetics is recalling 140 I-Portal NOTC and VNG devices due to system malfunctions and unintended sudden movements at startup. No injuries have been reported.
Product
I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1808-2015·2015-06-24
AMUSA Sterile Field Flush Syringe Recalled for Incorrect Expiration Date Labeling
MRP, LLC dba AMUSA is recalling 1,080 units of T/S2 0.9% Sodium Chloride Injection flush syringes due to incorrect expiration date labeling.
Product
T/S2 0.9% Sodium Chloride Injection, USP, AMUSA Sterile Field Flush Syringe, 10 mL in 12 mL Single Use Syringe, Rx only, Part no. 2S0706 Usage: Flush syringe.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1800-2015·2015-06-24
Synthes Recalls 3.7mm Cannulated Screws Due to Incorrect Labeling
Synthes, Inc. is recalling 54 units of 3.7mm Cannulated Locking and Conical Screws because certain lots were found to have been labeled incorrectly.
Product
3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, particularly in osteopenic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1798-2015·2015-06-24
Biomet Vanguard M Unicondylar Tibial Trial Recalled for Incorrect Etching
Biomet, Inc. is recalling 27 Vanguard M Unicondylar Tibial Trials because the left and right orientation markings are incorrectly etched on the handle.
Product
Vanguard M Unicondylar Tibial Trial For use during knee joint replacement.
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-1797-2015·2015-06-24
Amerx Recalls Amerigel Hydrogel Gauze Dressing for Nonapproved Sterile Labeling
Amerx Health Care Corp. is recalling Amerigel Hydrogel Gauze Dressing 2 x 2 due to nonapproved labeling claims regarding sterility.
Product
Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management.
Category
Medical Device
Distribution
45 states
ModerateFDA (Devices)·Z-1814-2015·2015-06-24
CooperSurgical Recalls MILEX OMNIFLEX Diaphragms Due to Packaging Error
CooperSurgical is recalling 200 units of MILEX OMNIFLEX Diaphragms because size 80 boxes were incorrectly packaged with size 85 diaphragms.
Product
MILEX OMNIFLEX DIAPHRAGM SIZE 80 Model: MXWF80
Category
Medical Device
Distribution
13 states
CriticalFDA (Devices)·Z-1726-2015·2015-06-17
HeartWare Ventricular Assist System Recalled for Driveline Connector Pin Retraction
HeartWare Inc is recalling HVAD systems due to complaints about pin retraction within the driveline connector. The recall affects 3,747 units currently in use worldwide.
Product
HeartWare Ventricular Assist System (HVAD). Catalog #: 1101, 1103, 1100, 1101, 1102, 1104, 1104JP, and 1205. Intended for use as a bridge to cardiac transplantation in patients who are at risk of death from refractory end-stage heart failure.
Category
Medical Device
Distribution
32 states
CriticalFDA (Devices)·Z-1706-2015·2015-06-17
Maquet FLOW-i Anesthesia System Recalled for Gas Leakage Risk
Maquet is recalling FLOW-i Anesthesia Systems because a dislodged patient cassette can cause gas leakage and stop ventilation.
Product
FLOW-i Anesthesia System The FLOW-i Anesthesia System is intended for use administering inhalation anesthesia on neonatal to adult patient populations.
Category
Medical Device
Distribution
12 states
SevereFDA (Devices)·Z-1767-2015·2015-06-17
Philips Medical Systems Recalls Extended Brilliance Workstation UPS Accessories
Philips Medical Systems is recalling Extended Brilliance Workstation UPS accessory devices due to risks of battery acid leakage, overheating, and fume emission.
Product
Extended Brilliance Workstation (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1750-2015·2015-06-17
ResMed Astral Ventilator Recall Due to Alarm Disabling Hazard
ResMed is recalling Astral 100 and 150 ventilators because clinicians can disable all alarms, including circuit disconnection alerts, posing a risk of insufficient ventilation.
Product
Astral 100 ( Model No. 27001) & Astral 150 (Model No. 27003) ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1738-2015·2015-06-17
Smith & Nephew R3 Constrained Liner Recalled for Locking Groove Defect
Smith & Nephew is recalling 40 units of R3 Constrained Liners because the locking groove is oversized, preventing the locking ring from engaging properly.
Product
R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1716-2015·2015-06-17
Fresenius CRIT-LINE Blood Chamber Recalled for Connection Leaks
Fresenius Medical Care is recalling CRIT-LINE Blood Chambers because the connection may leak during use.
Product
CRIT-LINE Blood Chamber- an accessory to the Crit line III- Monitors in real time blood parameters Model: CL10021021
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1770-2015·2015-06-17
Philips Ingenuity Flex UPS Accessory Devices Recalled for Battery Acid Leakage
Philips Medical Systems is recalling 23 Ingenuity Flex UPS accessory devices used with CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Product
Ingenuity Flex (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1779-2015·2015-06-17
Philips Precedence 6 UPS Accessory Devices Recalled for Battery Acid Leakage
Philips Medical Systems is recalling Precedence 6 UPS accessory devices for CT and diagnostic imaging systems due to risks of battery acid leakage, overheating, and fume emission.
Product
Precedence 6 (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1699-2015·2015-06-17
Zimmer Recalls M/L Taper Hip Stems Due to Cytotoxicity Levels
Zimmer is voluntarily recalling 752 M/L Taper hip implants because they contain higher than allowed cytotoxicity levels, posing a risk of adverse biological response.
Product
M/L Taper with Kinectiv¿ Technology. prosthesis, hip, semi-constrained (metal uncemented acetabular component) Product Usage: Usage: Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1781-2015·2015-06-17
Philips Gemini GXL 16 Slice CT Systems Recalled for UPS Battery Hazards
Philips is recalling 15 Gemini GXL 16 Slice CT systems worldwide because their UPS accessory devices may leak battery acid, overheat, or emit fumes.
Product
Gemini GXL 16 Slice (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1734-2015·2015-06-17
Roche Recalls Accu-Chek Spirit Insulin Pumps Due to Mechanical Errors
Roche Diabetes Care is recalling Accu-Chek Spirit insulin pumps because mechanical errors may stop insulin delivery, potentially leading to severe hyperglycemia.
Product
AccuChek Spirit insulin infusion pump.
Category
Medical Device
Distribution
Distributed nationwide

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32901–32925 of 40449