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

27876–27900 of 40357

ModerateFDA (Devices)·Z-1040-2017·2017-01-25
Beckman Coulter AutoMate 2500 Family Recalled for Operating System Update
Beckman Coulter is recalling four AutoMate 2500 Family units in Maryland to update the PC image for Windows 10 compatibility.
Product
AutoMate 2500 Family Catalog No. ODL25120 AutoMate 1200, ODL25125, AutoMate 1250, ODL25250 AutoMate 2500, ODL25255 Automate 2550. AutoMate 1200/1250/2500/2550 System Series is a semi-open, pre- and post-analytical sample processing and sorting system. The base system…
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-1024-2017·2017-01-25
Zimmer Biomet Recalls ArComXL Polyethylene Liners Due to Labeling Mismatch
Zimmer Biomet is recalling 36 units of ArComXL polyethylene liners because packaging labels did not match the physical product, posing a risk of surgical delay.
Product
RingLoc ArComXL Highly Crosslinked Polyethylene Liners ArComXL High Wall +3mm Liners Size 23 item XL-108323 ArComXL MaxRom +3mm Liners Size 23 item XL-108223
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1052-2017·2017-01-25
Carestream Ultrasound Systems Recalled for Software Measurement Unit Error
Carestream Health Inc. is recalling Touch Prime and Touch Prime XE ultrasound systems due to a software error that may display incorrect measurement units.
Product
Carestream Touch Prime, Catalog # 1738830, and Touch Prime XE, Catalog # 1738822, Ultrasound System Diagnostic ultrasound imaging or fluid flow analysis of the human body
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-1037-2017·2017-01-25
Endologix AFX Endovascular AAA System Instructions for Use Updated
Endologix updated the Instructions for Use and modified the AFX Endovascular AAA System. The correction applies to procedures conducted after July 2015.
Product
AFX Endovascular AAA System, Endoleak Type IIIA Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment The AFX Endovascular AAA System is intended for endovascular treatment of patients with…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1047-2017·2017-01-25
Endologix Updates Instructions for Use for AFX Endovascular AAA System
Endologix is updating the Instructions for Use and making modifications to the AFX Endovascular AAA System. This applies to procedures conducted after October 2015.
Product
AFX Endovascular AAA System, Endoleak Type IIIA Product Usage: The AFX Endovascular AAA System is intended for endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms (AAA).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1043-2017·2017-01-25
Optilite Freelite Lambda Free Kit Recalled for Inaccurate Test Results
The Binding Site Group is recalling 809 Optilite Freelite Lambda Free Kits because specific lots produce test results that are approximately 33% lower than expected.
Product
Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1054-2017·2017-01-25
Endologix Updates Instructions for Use for AFX Endovascular AAA System
Endologix is recalling 17,139 units of the AFX Endovascular AAA System to update the Instructions for Use and implement device modifications.
Product
AFX Endovascular AAA System, Endoleak Type IIIB Common Name: AFX Bifurcated and Accessory Stent Grafts Classification Name: System, Endovascular Graft, Aortic Aneurysm Treatment
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1048-2017·2017-01-25
Endologix AFX Endovascular AAA System Recall for Updated Endoleak Information
Endologix is recalling 34 units of the AFX Endovascular AAA System to provide updated information regarding Type III endoleak rates and patient surveillance.
Product
AFX Endovascular AAA System Item Number Item Description F0070305 A2525/C75 V F0070308 A2828/C75 V F0070312 A3434/C80 V f00553 I1616/C55F SA F00556 I2013/C70F SA…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1035-2017·2017-01-25
Endologix AFX Endovascular AAA System Clinical Data Correction
Endologix is correcting cumulative clinical data reports for the AFX Endovascular AAA System and Powerlink System. This action applies to procedures conducted after June 2013.
Product
AFX Endovascular AAA System, Endoleak Type IIIA
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-1045-2017·2017-01-25
DICOM GRID Recalls Ambra PACS Software Due to Image Display Error
DICOM GRID Inc. is recalling Ambra PACS software version V3.16.13.0 because a defect causes diagnostic images to appear washed out, potentially affecting image analysis.
Product
Ambra PACS UDI: +AMBRHEALTHSOLUTIONS0/$$+7_V3.16.13.0R Software Version Number: V3.16.13.0 Intended for use as a primary diagnostic and analysis tool for diagnostic images.
Category
Medical Device
Distribution
27 states
ModerateFDA (Devices)·Z-1041-2017·2017-01-25
Smith & Nephew RENASYS GO Wound Therapy Recall for Clearance Issue
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy devices because they lack 510(k) clearance for a design modification.
Product
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious materials. Used for…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1042-2017·2017-01-25
Smith & Nephew RENASYS GO Power Supply Recalled for Regulatory Clearance
Smith & Nephew is recalling RENASYS GO Negative Pressure Wound Therapy External Power Supply Units because they lack 510(k) clearance for a design modification.
Product
Smith & Nephew, RENASYS GO Negative Pressure Wound Therapy External Power Supply Unit, Rx only. Intended for patients who would benefit from a suction device to help promote wound healing by removing fluids, including irrigation and body fluids, wound exudates and infectious…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1030-2017·2017-01-25
Exactech Recalls Novation Cemented Plus Femoral Stems Due to Labeling Error
Exactech is recalling 79 Novation Cemented Plus Femoral Stems because they were labeled with incorrect Global Trade Item Numbers (GTINs).
Product
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Category
Medical Device
Distribution
13 states
SevereFDA (Devices)·Z-1015-2017·2017-01-18
GE Healthcare Recalls Infant Warmer Systems Due to Loose Heater Screws
GE Healthcare is recalling Infant Warmer Systems because loose screws in the Heater Head could fall and cause thermal injury to patients.
Product
Infant Warmer System (IWS)
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-1009-2017·2017-01-18
Elekta Monaco RTP System Recalled for Incorrect Wedge Calculations
Elekta is recalling 279 Monaco RTP Systems because they may calculate Enhanced Dynamic Wedge or Virtual Wedge values incorrectly.
Product
Monaco RTP System Product Usage: Used to make treatment plans for patients with prescriptions for external beam radiation therapy.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0984-2017·2017-01-18
Medline E-Z Lubricating Jelly Recalled Due to Lack of Sterilization
Medline is recalling 12,024 tubes of E-Z Lubricating Jelly because they were not sterilized due to a shipping error.
Product
Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1008-2017·2017-01-18
Smith & Nephew Recalls Reflection Dead Blow Mallets Due to Weld Cracks
Smith & Nephew is recalling Reflection Dead Blow Mallets because cracks in the weld allowed lead beads to escape into surgical wounds.
Product
REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1020-2017·2017-01-18
Stryker Recalls Reunion TSA Peg Alignment Sound Due to Breakage
Stryker Howmedica Osteonics Corp. is recalling 131 units of the Reunion TSA Peg Alignment Sound because the instrument broke during surgery.
Product
Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (PIN 5901-1038, Revision A) is an instrument used in the ReUnion TSA shoulder system for confirming seating height and peg alignment of the TSA Self-Pressurizing Polyethylene Glenoid implant prior to…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0978-2017·2017-01-18
Alcon Monarch III Cartridge Recalled Due to Potential Lens Lodging
Alcon Research, Ltd. is recalling 1,130 Monarch III (1) "C" Cartridges because the intraocular lens could become lodged within the device.
Product
Alcon Monarch III (1) "C" Cartridge The device is used for implanting AcrySof intraocular lenses in the eye following cataract removal
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0964-2017·2017-01-18
Stryker Recalls Reprocessed Electrophysiology Catheter Cables Due to Sterility Breach
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheter cables because a breach in sterile packaging may have occurred, potentially rendering the product non-sterile.
Product
Reprocessed Electrophysiology Catheter Cables Catalog Number: CB3434CT, D134401, CB3410CT, CB3412CT Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The…
Category
Medical Device
Distribution
35 states
HighFDA (Devices)·Z-0987-2017·2017-01-18
Elekta Oncentra Radiation Therapy Software Recalled for Cross Profile Defect
Elekta, Inc. is recalling Oncentra External Beam and Brachy software because a cross profile for a Varian 60-degree wedge shows 'horns.' The recall covers 433 units distributed worldwide.
Product
Oncentra External Beam Oncentra Brachy Product Usage: Oncentra is radiation therapy planning software designed to analyze and plan radiation treatment is three dimensions for the purpose of treating patients with cancer.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2017·2017-01-18
Medtronic MRI-Conditional Cardiac Devices Recalled for Software Feature Error
Medtronic is recalling 21,111 MRI-conditional cardiac resynchronization therapy devices because the AdaptivCRT feature may appear enabled when it is not active.
Product
Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular…
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0967-2017·2017-01-18
C.R. Bard Recalls Medical Devices Containing Latex Catheters
C.R. Bard is recalling specific medical device trays and stabilization devices because they contained latex catheters instead of silicone catheters.
Product
SURESTEP Tray, BARDEX I.C. COMPLETE CARE, Urine Meter, Temperature STATLOCK Stabilization Device
Category
Medical Device
Distribution
23 states
HighFDA (Devices)·Z-1011-2017·2017-01-18
Symmetry Surgical ULTRA Sterrad Container Recall for Sealant Defect
Symmetry Surgical is recalling 149 ULTRA Sterrad containers because deteriorated or missing base trim sealant may allow contaminants to enter the container after sterilization.
Product
symmetry surgical ULTRA(R) Sterrad container, REF numbers: C131310-SP, C13134-SP, C13135-SP, C13136-SP, C13139-SP, C13854-SP, C13855-SP, C13856-SP, C181310-SP, C18134-SP, C18135-SP, C18136-SP, C18138-SP, C22854-SP, C22855-SP, C22856-SP, C22858-SP, C24134-SP, C24135-SP…
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1006-2017·2017-01-18
Philips IQon Spectral CT Recalled for Image and Scan Errors
Philips is recalling 35 IQon Spectral CT systems due to software issues causing rescans, incorrect scan locations, or misrepresentation of image results.
Product
IQon Spectral CT with software version 4.7.0 Product Usage: The IQon Spectral CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This…
Category
Medical Device
Distribution
Distributed nationwide

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27876–27900 of 40357