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

34451–34475 of 40325

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
LowFDA (Devices)·Z-0208-2015·2014-11-19
CooperSurgical MILEX Pessary Kits Recalled for Incorrect Expiration Date
CooperSurgical is recalling 6 units of MILEX Pessary Kits due to incorrect expiration dates printed on the packaging.
Product
CooperSurgical MILEX PESSARY KITS- Hodge w/Support Folding Pessary- #1 Model: MXKPHS01 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
SevereFDA (Devices)·Z-0156-2015·2014-11-12
Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling specific Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0125-2015·2014-11-12
TriVascular Recalls Ovation Prime Abdominal Stent Grafts Due to Injection Issue
TriVascular is recalling specific lots of Ovation Prime Abdominal Stent Grafts because the fill polymer syringe may empty rapidly during the implant procedure.
Product
Ovation Prime Abdominal Stent Graft System - 29mm Aortic Body stent grafts. The TriVascular Ovation Prime Abdominal Stent Graft System is a low-profile endovascular device delivered via catheter to treat descending abdominal aortic aneurysms (AAAs).
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-0084-2015·2014-11-12
Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path
Baxter Healthcare Corp is recalling 94,224 INTRA VIA containers due to particulate matter found inside the fluid path.
Product
Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, 150 ml, Admixture Products and Accessories. The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0085-2015·2014-11-12
Baxter INTRA VIA Container Recalled for Particulate Matter in Fluid Path
Baxter Healthcare is recalling 20,448 units of INTRA VIA containers due to particulate matter found inside the fluid path.
Product
Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogenic fluid path) ,500 ml. Admixture Products and Accessories The lntraVia Empty Plastic Container is intended for use in the preparation and administration of drug admixtures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0168-2015·2014-11-12
IBA Dosimetry Recalls COMPASS Software Due to Dose Calculation Errors
Iba Dosimetry Gmbh is recalling COMPASS software version 3.1 because a defect may prevent detection of dose distribution errors, potentially leading to incorrect radiation doses during treatment.
Product
COMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiological
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0159-2015·2014-11-12
Terumo Cardiovascular Procedure Kits Recalled for Luer Connector Defect
Terumo is recalling specific cardiovascular and perfusion procedure kits because a luer connector defect may compromise the seal and introduce air into the table line.
Product
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0169-2015·2014-11-12
Cynosure Elite XPL Handpiece Recalled for Electrical Shock Risk
Cynosure, Inc. is recalling 322 Elite XPL handpieces for the Elite MPX Laser System due to a potential risk of electrical shock when the device is adjusted or removed while powered on.
Product
Elite XPL (Pulsed Light) Handpiece for the Cynosure Elite MPX Laser System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0178-2015·2014-11-12
Dokitz NovoSci Recalls Cardiopulmonary Bypass Connectors Due to Detachment Risk
Dokitz NovoSci is recalling 240 units of cardiopulmonary bypass connectors because the single leg of the PAY connector has been observed to become detached.
Product
Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0157-2015·2014-11-12
Terumo Cardioplegia Delivery Set Line Recalled for Luer Connector Defect
Terumo is recalling 165 units of a cardioplegia delivery set line because a luer connector defect can compromise the seal and introduce air into the line.
Product
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes the female luer connector that is the subject of this correction/removal…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0158-2015·2014-11-12
Terumo Cardioplegia Delivery Set Recalled for Luer Connector Seal Defect
Terumo is recalling 777 Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0160-2015·2014-11-12
Terumo Custom Cardioplegia Delivery Set Recalled for Luer Connector Defect
Terumo is recalling Custom Cardioplegia Delivery Sets because a defect in the luer connector can compromise the seal and introduce air into the tubing line.
Product
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed to deliver…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0161-2015·2014-11-12
Terumo Custom Cardioplegia Delivery Sets Recalled for Luer Connector Seal Defect
Terumo is recalling 24 units of Custom Cardioplegia Delivery Sets because a luer connector defect may compromise the seal and introduce air into the line.
Product
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0165-2015·2014-11-12
Zimmer Surgical Recalls Universal Modular Electric Handpieces Due to Malfunction
Zimmer Surgical Inc is recalling 828 Universal Modular Electric/Battery Handpieces because a malfunction allows them to start unexpectedly when connected to a power source.
Product
UNIVERSAL Modular Electric/Battery Handpiece for surgery The electric handpiece is packaged within a foam bag inside of a padded-foam corrugate box. An operating manual is packed with the handpiece between the top foam pad and box lid. A product label is applied to the lid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0172-2015·2014-11-12
Stryker SmartLife Aseptic Housings Recalled for Welding Defect
Stryker is recalling SmartLife Large Aseptic Housings because the top section may separate from the bottom due to insufficient welding.
Product
Stryker SmartLife Large Aseptic Housing REF 7126-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0163-2015·2014-11-12
C.R. Bard Recalls 86 Non-Sterile Bard Dimension Stone Baskets
C.R. Bard is recalling 86 non-sterile Bard Dimension Stone Baskets due to a Class II recall classification.
Product
Bard Dimension Stone Basket Product Usage: The Bard Dimension Stone basket is a teardrop-shaped basket with the ability to capture stones by, opening and closing the basket and articulating or moving the basket from side to side. The device consists of 3 main parts; handle…
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-0173-2015·2014-11-12
Stryker SmartLife Aseptic Housings Recalled for Welding Defect
Stryker is recalling SmartLife Small Aseptic Housings because the top section may separate from the bottom due to insufficient welding.
Product
Stryker SmartLife Small Aseptic Housing REF 7222-120-000 Rx Only The SmartLife" Aseptic Housings are designed to be used in conjunction with the SmartLife Non-Sterile Batteries to provide power for System 7 Handpieces, Cordless Driver 4 Handpiece, and Sabo2 Sagittal Saw…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0177-2015·2014-11-12
St. Jude Medical Recalls Electrophysiology Catheters Due to Incorrect Packaging
St. Jude Medical is voluntarily recalling 26 electrophysiology catheters because the packaging contains the wrong device model. No serious injuries have been reported.
Product
St. Jude Medical, Fixed Curve Response 6F Electrophysiology Catheter, CSL, Model 401353
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0176-2015·2014-11-12
Beckman Coulter Recalls DxC 600i Analyzer Console PC Due to Error
Beckman Coulter is recalling the Small Form Factor Console PC for the DxC 600i analyzer because it may experience an 'MFC Exception' error during normal operation.
Product
UniCel DxC 600i SYNCHRON Access Clinical Analyzer, Catalog No. A25640, Instructions for Use Part No. A93659AB. Product Usage: The DxI 600i systems are in vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analytes…
Category
Medical Device
Distribution
Distributed nationwide

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34451–34475 of 40325