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

22201–22225 of 27663

HighFDA (Devices)·Z-0915-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 199 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548340 (XMD P/N 70-0050-114) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1010-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 36 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549590 (XMD P/N 70-0050-F24) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0894-2016·2016-03-02
Olympus GIF-Q180 Video Gastroscope Recall for Detached Coil Assembly
Integrated Medical Systems Inc. is recalling 185 Olympus GIF-Q180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing angulation from operating as intended.
Product
Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0918-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548820 (XMD P/N 70-0050-120) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0974-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548310 (XMD P/N 70-0050-A12) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0824-2016·2016-03-02
Siemens BCS Blood Coagulation Analyzer Recall for False Results
Siemens is recalling BCS Automated Blood Coagulation Analyzer Systems because they may produce falsely short clotting times and low PT INR values when testing specific types of patient samples.
Product
BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 34 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M005489490 (XMD P/N 70-0050-524) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2016·2016-03-02
Olympus Video Colonoscope Recalled for Potential Internal Coil Detachment
Integrated Medical Systems Inc is recalling one Olympus video colonoscope because excessive pressure may cause the internal coil pipe to detach, affecting angulation.
Product
Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0990-2016·2016-03-02
Xeridiem EndoVive 3s Balloon Kits Recalled for Feeding Valve Leakage
Xeridiem is recalling 40 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00548770 (XMD P/N 70-0050-C18) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0960-2016·2016-03-02
Xeridiem EndoVive 3s Low Profile Balloon Kits Recalled for Valve Leakage
Xeridiem is recalling 43 EndoVive 3s Low Profile Balloon Kits because the feeding valve may close inconsistently, allowing fluid to leak.
Product
EndoVive 3s Low Profile Balloon Kits Part Number: M00549510 (XMD P/N 70-0050-724) The EndoVive 3s Low Profile Balloon is intended to provide gastric access through a gastrointestinal stoma tract for enteral feeding, medication administration and gastric decompression. The…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0868-2016·2016-03-02
Stryker Recalls Metaizeau Intramedullary Pins Due to Packaging Seal Concerns
Stryker is recalling 147,838 Metaizeau Intramedullary Pins because packaging seal integrity may be decreased, potentially affecting sterility.
Product
Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0890-2016·2016-03-02
Olympus GIF-H180 Video Gastroscope Recalled for Distal Coil Detachment
Integrated Medical Systems Inc is recalling 275 Olympus GIF-H180 video gastroscopes because excessive pressure can cause the internal coil pipe assembly to detach, preventing proper angulation.
Product
Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0819-2016·2016-02-24
Medtronic Recalls Endo GIA Ultra Universal Short Stapler Handles
Medtronic is recalling 364,768 Endo GIA Ultra Universal Short Stapler Handles because they may fail to fire or partially fire, and the articulating lever may disengage during use.
Product
Covidien Endo GIA Ultra Universal 12 mm Short Stapler Handle Ref: EGIAUSHORT Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0822-2016·2016-02-24
Medtronic Recalls Endo GIA Ultra Universal Stapler Handles in Best Practice Kits
Medtronic is recalling 2,711 Best Practice Kits containing specific Endo GIA Ultra Universal Stapler Handles due to reports of staplers failing to fire or partially firing, and articulating levers disengaging during use.
Product
Best Practice Kits containing certain production lots of Endo GIA Ultra Universal Stapler Handles Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0820-2016·2016-02-24
Medtronic Recalls Endo GIA Ultra Universal Stapler Handles Due to Firing Defects
Medtronic is recalling 1,102,166 Endo GIA Ultra Universal Standard Stapler Handles worldwide because they may fail to fire or partially fire during surgery.
Product
Covidien Endo GIA Ultra Universal Standard Stapler Handle Ref: EGIAUSTND Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0805-2016·2016-02-24
Varian Eclipse Treatment Planning System Recall for Dose Calculation Error
Varian Medical Systems is recalling Eclipse Treatment Planning System versions 11, 13.0, 13.5, and 13.6 due to a dose calculation error that may result in unintended radiation exposure.
Product
Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0821-2016·2016-02-24
Medtronic Recalls Endo GIA Ultra Universal 12 mm XL Stapler Handles
Medtronic is recalling 327,797 Endo GIA Ultra Universal 12 mm XL Stapler Handles worldwide because the staplers may fail to fire or the articulating lever may disengage during surgery.
Product
Covidien Endo GIA Ultra Universal 12 mm XL Stapler Handle Ref: EGIAUXL Product Usage: The Endo GIA Ultra Universal Short, Endo GIA Ultra Universal and Endo GIA Ultra Universal XL staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0818-2016·2016-02-24
Smith & Nephew Recalls High Flow Irrigation Extender for Separation Risk
Smith & Nephew is recalling 203 High Flow Irrigation Extenders because the device body may separate during surgery, potentially obstructing visualization and causing fluid leakage.
Product
High Flow Irrigation Extender; Part Number 72201021. Arthroscopic accessories are indicated for use in access of the joint capsule.
Category
Medical Device
Distribution
15 states
HighFDA (Devices)·Z-0807-2016·2016-02-24
Bio-Rad EVOLIS Microplate System Recalled for Plate Transport Hazard
Bio-Rad is recalling 278 EVOLIS Microplate Systems because a low fluid alarm could cause the plate transport to continue running, pushing plates off the transporter.
Product
EVOLIS Microplate System, Catalog # 89601. Part number 89788 for the EVOLIS Operator's Manual. in vitro diagnostic Product Usage: EVOLIS Microplate System is a 4 plate fully integrated microplate processing system designed for use with multiple EIA assays.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0810-2016·2016-02-24
Philips recalls actuator assemblies for angiographic x-ray monitor ceiling suspension systems
Philips is recalling actuator assemblies for angiographic x-ray monitor ceiling suspension systems because the actuator can detach, causing the monitor carriage to drop.
Product
Actuator for angiographic x-ray monitor ceiling suspension system. Actuator short Assy: THC8AWDS-121 and Actuator long Assy: THC8AWDS-122 used with the following products: 722001 Allura Xper FD 10 C; 722003 Allura Xper FD10; 722005 Allura Xper FD10/10; 722006 Allura Xper FD20…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0817-2016·2016-02-24
Nihon Kohden MEE-1000A Neuromaster Accessories Recalled for Defective Circuit Boards
Nihon Kohden America Inc is recalling MEE-1000A Neuromaster accessories due to defective printed circuit boards that failed to prevent unintentional current flow.
Product
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0806-2016·2016-02-24
ViewRay MRIdian Radiation Therapy System Recalled for Treatment Interruption Error
ViewRay is recalling five MRIdian Radiation Therapy Systems because they loaded a completion fraction in the incorrect order after a treatment interruption.
Product
MRIdian ViewRay Radiation Therapy System, VIEWRAY Inc.
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0814-2016·2016-02-24
CareFusion Recalls Jadak Barcode Scanners for Pyxis Anesthesia Systems
CareFusion 303, Inc. is recalling 9,345 Jadak Barcode Scanners used with Pyxis Anesthesia systems because they may transmit incorrect medication information to the dispensing system.
Product
Jadak Barcode Scanner, Part No. 350587-32, 350587-41, 351377-32. Product Usage: An accessory for the Pyxis Anesthesia ES system and Pyxis Anesthesia system 4000 stations. The Jadak Barcode Scanner is used to scan medication labels during refill of the Pyxis Anesthesia ES…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0767-2016·2016-02-17
Mevion S250 Radiation Therapy System Recalled for Positioning Belt Slippage
Mevion Medical Systems is recalling four MEVION S250 Radiation Therapy Systems because the treatment table positioning belt can slip, causing patient setup deviations.
Product
MEVION S250 Radiation therapy system
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0765-2016·2016-02-17
Philips Allura Xper FD OR Table Recalled for C-Arc Movement Issue
Philips is recalling two Allura Xper FD OR Tables because the C-arc may continue moving after stopping due to improper adjustment.
Product
Allura Xper FD OR Table, Ceiling version only; 722035; imaging applications.
Category
Medical Device
Distribution
2 states

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22201–22225 of 27663