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

34526–34550 of 40449

SevereFDA (Devices)·Z-0181-2015·2014-11-19
Philips Allura Xper FD20C Radiological Imaging Systems Recalled for Motion Controller Fault
Philips is recalling 22 Allura Xper FD20C radiological imaging systems due to a faulty Automatic Motion Controller that may cause hazardous movement of the C-arc.
Product
Philips Medical Systems Allura Xper FD20C Radiological Imaging with software version R8.2.O; System Code: 722028. The Allura Xper FD series are intended for use on human patients to perform: Vascular, cardiovascular and neurovascular imaging applications, including…
Category
Medical Device
Distribution
2 states
SevereFDA (Devices)·Z-0186-2015·2014-11-19
GE Discovery NM/CT 670 Imaging System Recalled for Loose Fasteners
GE Healthcare is recalling 255 Discovery NM/CT 670 systems because loose fasteners may cause a portion of the system to fall onto patients during scans.
Product
Discovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Models H3100NA, H3100PP, H3100RA, H2401LS, H2401LZ, H2402LS. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0196-2015·2014-11-19
Steris 5085 Surgical Tables Recalled for Damaged Column Shrouds
Steris is recalling 5085 and 5085SRT surgical tables because column shrouds may become damaged, potentially preventing the table from raising or lowering.
Product
The 5085 is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation.
Category
Medical Device
Distribution
36 states
HighFDA (Devices)·Z-0209-2015·2014-11-19
American Medical Systems Recalls AMS 700 Series Inflatable Penile Prosthesis Accessory Kits
American Medical Systems is recalling AMS 700 Series Accessory Kits because supplier-supplied Keith needles may bend or break when used with the Furlow tool.
Product
AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850. Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (Furlow), the Keith Needles facilitate the passing of the pulling sutures…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0199-2015·2014-11-19
DePuy ATTUNE Intuition Distal Femoral Jig Recall for Bushing Defect
DePuy Orthopaedics is recalling ATTUNE Intuition Distal Femoral Jigs because a pin bushing defect could cause the plastic to fracture or displace during use.
Product
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0200-2015·2014-11-19
Remel Legionella Growth Supplement Recalled for Potential False Negative Results
Remel Inc is recalling Legionella BCYE Growth Supplement because it may fail to recover Legionella pneumophila, leading to false negative identification.
Product
Oxoid Legionella BCYE Growth Supplement SR0110A, packaged in 100 ml vials, 10/pkg. A growth supplement for the isolation of Legionella.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0183-2015·2014-11-19
Siemens Artis zeego C-arm systems recalled for cable routing defect
Siemens is recalling 164 Artis zeego systems because a cable may be routed incorrectly, potentially causing system failure during procedures.
Product
Artis zeego systems, model number 10280959, with serial numbers 1000-1599 : Artis zeego is a dedicated angiography system developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0213-2015·2014-11-19
Masimo SET uSpO2 Pulse Oximetry Cables Recalled for Crossed Wires
Masimo Corporation is recalling specific SET uSpO2 Pulse Oximetry Cables due to crossed internal wires that may cause the monitoring device to display inverted SpO2 values.
Product
Masimo SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that provides continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (Sp02) and pulse rate when installed in a compatible OEM host system. Shipping/Package…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0185-2015·2014-11-19
GE Healthcare Recalls Varicam and VG Hawkeye Nuclear Medicine Devices
GE Healthcare is recalling 478 nuclear medicine imaging devices because loose fasteners could cause a portion of the system to fall onto a patient during a scan.
Product
GE Healthcare Varicam/VG and VG Hawkeye devices. Models H3000YA, H3000YB, H3000YC, H3000YD, H2508PA, H2508PB, H2508PC, H2508PD. Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0197-2015·2014-11-19
Integra Titan Reverse Shoulder System Cutting Templates Recalled for Manufacturing Error
Integra LifeSciences Corp. is recalling 12 units of Reverse Shoulder System cutting templates because the threaded handle was welded backwards, resulting in an incorrect cutting angle.
Product
Integra Titan Reverse Shoulder System right and left head cutting templates, 142.5 degrees. The Reverse Shoulder System Cutting Template, 142.5 degrees is an accessory for use with the Integra Titan Reverse Shoulder System. It is used to project the osteotomy angle on the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0189-2015·2014-11-19
GE Healthcare Recalls Brivo NM615 Nuclear Imaging Systems Due to Loose Fasteners
GE Healthcare is recalling 22 Brivo NM615 nuclear imaging systems because loose fasteners could cause a portion of the system to fall onto a patient during a scan.
Product
Brivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Models H3100TP, H3100TN, H3100TT, H3100TR, H3100TW, H3100WZ, H2401MP, H2401MN, H2401MT, H2401MR, H2401MW, H2401NJ. Product Usage: The Brivo NM 615 is an emission computed tomography system…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0187-2015·2014-11-19
GE Healthcare Recalls Discovery NM 630 Nuclear Imaging Systems
GE Healthcare is recalling 147 Discovery NM 630 nuclear imaging systems to update maintenance procedures and prevent loose fasteners from causing parts to fall on patients.
Product
Discovery NM 630, dual detector free-geometry integrated nuclear imaging system. Models H3100RC, H3100RD, H2401LW. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0204-2015·2014-11-19
Roscoe Medical Recalls Transport Rollators Due to Caster Separation Risk
Roscoe Medical Inc is recalling 831 Transport Rollators because the caster may separate from the frame, posing an injury risk to users.
Product
Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), fold down footrests, ergonomic handles, curved padded backrest and handy wire basket for storage. Item# 30192 Burgundy each/Item# 30194 Blue each.. Transport Rollator is a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0191-2015·2014-11-19
Bard PerFix Light Plug Recalled for Labeling Mismatch
Davol, Inc. is recalling 78 units of Bard PerFix Light Plug because the patient record label did not match the actual product in the packaging.
Product
Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
Category
Medical Device
Distribution
8 states
ModerateFDA (Devices)·Z-0211-2015·2014-11-19
Maquet Cardiohelp-I System Recalled for Potential Software Display Error
Maquet Cardiovascular is recalling 331 Cardiohelp-I Systems due to a software issue that may display an erroneous 'Battery Needs Service' message after startup.
Product
Cardiohelp-I System Product Usage: A blood oxygenation and carbon dioxide removal system used to pump blood thorough the extracorporeal bypass circuit for circulatory and/or pulmonary support during procedures requiring cardiopulmonary bypass (for periods up to six hours).…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0193-2015·2014-11-19
GE OEC MiniView 6800 C-Arm Recall for Component Revision
GE Healthcare is recalling 26 OEC MiniView 6800 C-Arms because prior component revisions may have been incorrectly installed.
Product
OEC¿ MiniView 6800. The Mini 6800 Digital Mobile C-Arm is designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imaging. The device is not intended for whole-body pediatric…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0205-2015·2014-11-19
Medtronic Launcher Coronary Guide Catheter Recalled for Incorrect Length
Medtronic Vascular is recalling 11 Launcher Coronary Guide Catheters because they have a usable length of 90 cm instead of the labeled 55 cm.
Product
Medtronic Launcher Coronary Guide Catheter; MODEL: LA6JR40K
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0201-2015·2014-11-19
Integra Licox Pt02 Monitor Recalled for USB Data Extraction Issues
Integra LifeSciences is recalling 60 Licox Pt02 monitors because the USB port may not allow users to extract trend data as described in the manual.
Product
Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-0192-2015·2014-11-19
GE OEC UroView 2800 Imaging Systems Field Correction for Component Revision
GE Healthcare is correcting OEC UroView 2800 systems because prior component revisions may have been incorrectly installed.
Product
OEC¿ UroView 2800. The UroView 2800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical. and interventional procedures
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0190-2015·2014-11-19
Philips MX 16-slice CT Scanner Recalled for Incorrect Image Orientation
Philips Medical Systems is recalling 708 MX 16-slice CT Scanner Systems because scan images may display left and right sides reversed, potentially leading to misinterpretation of patient position.
Product
MX 16-slice CT Scanner System and MX 16-slice CT Scanner System Phase 11 can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY…
Category
Medical Device
Distribution
20 states
ModerateFDA (Devices)·Z-0198-2015·2014-11-19
Zimmer Persona Stemmed 5 Degree Cemented Tibia Recalled for Cleaning Failure
Zimmer, Inc. is recalling 138 units of Persona Stemmed 5 Degree Cemented Tibia knee components due to a cleaning process validation failure.
Product
Persona Stemmed 5 Degree Cemented Tibia Product Usage: This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0194-2015·2014-11-19
GE Healthcare Recalls FlexiView 8800 Digital Mobile Imaging Systems
GE Healthcare is recalling five FlexiView 8800 systems because prior component revisions were potentially installed on these units.
Product
FlexiView 8800 Digital Mobile Imaging System. The FlexiView 8800 Digital Mobile Imaging System is designed to provide fluoroscopic and spot film, imaging of the patient during diagnostic, surgical and interventional procedures.
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0195-2015·2014-11-19
GE OEC 9800 Medical Imaging Systems Field Correction for Component Revision
GE Healthcare is correcting 311 OEC 9800 imaging systems worldwide because prior component revisions may have been incorrectly installed.
Product
Series OEC 9800. The Series OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient,during diagnostic, surgical and interventional procedures.
Category
Medical Device
Distribution
0 states
LowFDA (Devices)·Z-0207-2015·2014-11-19
CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 17 MILEX Pessary Kits because the packaging displays an incorrect expiration date.
Product
CooperSurgical MILEX PESSARY KITS-Ring w/Support Folding Pessary- #1 Model: MXKPRS01 Product Usage: The CooperSurgical Milex silicon pessary is a safe and effective device used to manage a number of gynecologic issues including pelvic support defects and stress urinary…
Category
Medical Device
Distribution
13 states
LowFDA (Devices)·Z-0212-2015·2014-11-19
Siemens IMMULITE Calcitonin Control Module Recalled for Typographical Error
Siemens Healthcare Diagnostics is recalling the IMMULITE Calcitonin Control Module due to a typographical error in the expiration date on the instructions for use.
Product
IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For in vitro diagnostic use with IMMULITE¿ Systems Analyzers for the quantitative measurement of calcitonin (thyrocalcitonin) in human serum or heparinized plasma, as an aid in…
Category
Medical Device
Distribution
9 states

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34526–34550 of 40449