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

19126–19150 of 27682

HighFDA (Devices)·Z-0033-2018·2017-10-25
St. Jude Medical Recalls Merlin@Home Software for Pacemaker Security
St. Jude Medical is recalling Merlin@Home software to mitigate the risk of unauthorized access to pacemakers using radio frequency communications.
Product
Merlin@Home Software Model EX2000 v8.2.2 for Merlin@Home Transmitter Models EX1150, EX1150W, EX1100, and EX1100W. The Merlin@home Transmitters are a component of St. Jude Medicals (SJM) Remote Care System. These Merlin@home transmitters are used to retrieve information from…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0022-2018·2017-10-25
St. Jude Medical Recalls Proclaim Elite Implantable Pulse Generators
St. Jude Medical is recalling 28,817 Proclaim 5 and 7 Elite Implantable Pulse Generators because battery longevity estimations may be inaccurate.
Product
Proclaim 5 Elite Implantable Pulse Generator and Proclaim 7 Elite Implantable Pulse Generator Models 3660, 3661, 3662, 3663, 3665, 3667
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0030-2018·2017-10-25
St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Assurity and Accent pacemaker models to mitigate the risk of unauthorized access via radio frequency communications.
Product
Assurity Model Numbers: PM1240, PM2240; Assurity + Model Number: PM2260; Accent Model Numbers: PM1210, PM2210, PM1222, PM2212; Accent MRI Model Numbers: PM1224, PM2218, PM2224 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0036-2018·2017-10-25
St Jude Medical Recalls ZENEX Pacemakers for Firmware Update
St Jude Medical is recalling 4,828 ZENEX pacemakers to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM 1250 and PM 2250 ZENEX; PM1282 and PM2282 ZENEX MRI These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0029-2018·2017-10-25
St Jude Medical Recalls Pacemakers for Unauthorized Access Risk
St Jude Medical is recalling specific Anthem and Allure/Relieve pacemakers to mitigate the risk of unauthorized access via radio frequency communications.
Product
Anthem Model Numbers: PM3210, PM3212; Allure/Relieve Model Numbers: PM3222, PM3242, PM3262, PM3542, PM3224, PM3244 Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P is indicated in one or more of the following permanent conditions…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0035-2018·2017-10-25
St Jude Medical Recalls 101 Implantable Pacemakers for Firmware Update
St Jude Medical is recalling 101 implantable pacemaker pulse generators to install new firmware that mitigates the risk of unauthorized access via radio frequency communications.
Product
PM1226 ACCENT ST MRI SR RF and PM2222 ACCENT ST These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0026-2018·2017-10-25
CareFusion Recalls Alaris Pump Modules Due to Flow Rate Variations
CareFusion 303, Inc. is recalling Alaris Pump Module model 8100 units due to reports of increased or decreased medication flows.
Product
Alaris Pump Module model 8100 manufactured between November 2011 and March 2012; Alaris Pump Module serviced with LVP Mechanism Sub Assembly (P/N) 10942012 between November 2011 and March 2012; Alaris Pump module Bezel Kit Assembly (P/N) 10964559) shipped between November…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0025-2018·2017-10-25
Medtronic Recalls VCLAS Laser Applicators Due to Saline Leakage Testing Defect
Medtronic is recalling 423 VCLAS laser applicator systems because they were not appropriately tested for saline leakage during manufacturing.
Product
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0003-2018·2017-10-18
St Jude Medical Recalls Fortify ICDs Due to Premature Battery Depletion
St Jude Medical is recalling approximately 90,563 Fortify and Fortify Assura implantable cardioverter defibrillators because they may exhibit premature battery depletion.
Product
Fortify VR - Model Numbers: CD1231-40 and CD1231-40Q; Fortify ST VR, Model Numbers: CD1241-40 and CD1241-40Q; Fortify Assura VR, Model Numbers: CD1257-40, CD1257-40Q, CD1357-40C, CD1357-40Q; Fortify Assura ST VR, Model Numbers: CD1263-40, CD1263-40Q, CD1363-40C, CD1363-40Q…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0004-2018·2017-10-18
St Jude Medical Recalls Unify Cardiac Resynchronization Therapy Defibrillators
St Jude Medical is recalling specific Unify and Quadra Assura cardiac resynchronization therapy defibrillators because they may exhibit premature battery depletion.
Product
Unify, Model Numbers: CD3231-40 and CD3231-40Q; Unify Quadra, Model Numbers: CD3249-40 and CD3249-40Q; Unify Assura, Model Numbers: CD3257-40, CD3257-40Q, CD3357-40C, CD3357-40Q; Quadra Assura, Model Numbers: CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q; Quadra Assura MP, Model…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0013-2018·2017-10-18
Handicare A-Series Patient Lifts Recalled for Premature Strap Wear
Handicare is recalling 8 A-Series patient lifts because the lift straps may wear prematurely at maximum load, posing a risk of patient drop.
Product
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0014-2018·2017-10-18
Handicare Recalls Carina Mobile Lifts Due to Small Locking Pin
Handicare AB is recalling nine Carina mobile lifts because they were delivered with locking pins that are too small. This defect may cause increased wear on internal components.
Product
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0011-2018·2017-10-18
Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results
Abbott is recalling 1,385 ARCHITECT c4000 cuvette segments because a detached post may cause falsely depressed patient results in adjacent cuvettes.
Product
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park, IL. Cuvette segments are a component to the ARCHITECT c4000 system. Cuvette segments are racks that sit in the reaction carousel and hold cuvettes. Each…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3239-2017·2017-10-11
Firefly Medical Recalls IVEA Product Part Number 16100 Model 500A
Firefly Medical is recalling 570 IVEA units because dowel pins can rotate and dislodge from leg castings after repeated use.
Product
IVEA Product Part Number 16100 Model 500A
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0006-2018·2017-10-11
Permobil Electric Wheelchair Bases Recalled for Top Plate Assembly Failure
Permobil is recalling 146 electric wheelchair bases due to a potential failure of the top plate assembly that connects the seating system to the base.
Product
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0005-2018·2017-10-11
Permobil Recalls Electric Wheelchairs Due to Top Plate Assembly Failure Risk
Permobil is recalling 5,539 Corpus II electric wheelchairs because the top plate assembly may fail, potentially disconnecting the seating system from the base.
Product
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR e) C500 CORPUS II f) C500 CORPUS II LR
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3164-2017·2017-10-04
Zimmer Biomet Recalls ECT Internal Fracture Fixation Drills
Zimmer Biomet is recalling 4,423 ECT Internal Fracture Fixation Drills because raw material anomalies may increase the risk of instrument fracture during use.
Product
ECT Internal Fracture Fixation Drill 2.0 mm Diameter (.079 Inch), Item Number/EDI 00231802000, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3181-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Drills and Screw Taps
Zimmer Biomet is recalling 1,129 orthopedic surgical drills and screw taps due to raw material anomalies that may increase the risk of instrument fracture.
Product
Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3183-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.
Product
ECT Internal Fracture Fixation Quick-Connect Drill 2.0 mm Diameter 12.5 cm Length, Item Number/EDI 00241002100, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3151-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Surgical Drill Bits and Screw Taps
Zimmer Biomet is recalling specific orthopedic surgical instruments due to a raw material anomaly that may increase the risk of instrument fracture during use.
Product
Zimmer Natural Nail System Calibrated Drill Long 4.3mm, Item Number/EDI 00249004443, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3196-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.
Product
Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3106-2017·2017-10-04
Spectranetics Bridge Occlusion Balloon Catheter Recalled for Guidewire Issues
Spectranetics is recalling Bridge Occlusion Balloon catheters because the guidewire may not pass through the device, potentially delaying treatment.
Product
Spectranetics Bridge Occlusion Balloon catheter, Sheath Compatibility 12F, Guidewire Compatibility 0.035in, Working Length 90cm, Balloon Outer Diameter 31mm, Balloon Length 80mm, Rx Only. Product Usage: It is a device used to occlude the vessel and prevent blood loss as the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3175-2017·2017-10-04
Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3202-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 150 nonsterile orthopedic drill bits because raw material anomalies may cause the instruments to fracture during use.
Product
Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-3199-2017·2017-10-04
Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk
Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.
Product
Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
Category
Medical Device
Distribution
Distributed nationwide

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19126–19150 of 27682