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

31076–31100 of 40325

HighFDA (Devices)·Z-0702-2016·2016-02-10
Philips Allura Xper X-ray Systems Recalled for Image Interpretation Error
Philips is recalling Allura Xper FD10 systems because a software defect may cause still images to be mistaken for live images during cardiovascular procedures.
Product
Allura Xper FD10, FD10 C, and FD10 F; Model Numbers: 722026 722010 722003 722002 722001 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0704-2016·2016-02-10
Philips Allura Xper OR Table Recall for Image Interpretation Error
Philips is recalling Allura Xper FD10 OR Tables because still images may be misinterpreted as live images during cardiovascular procedures.
Product
Allura Xper FD10 OR Table; Model Numbers: 722033 722022 Intended for Cardiovascular and vascular X-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placement and atherectomies), pacemaker implantations and ElectroPhysiology (EP).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0696-2016·2016-02-10
Global Healthcare Recalls ET-20 Anesthesia Extension Tubes Due to Kinking
Global Healthcare Inc. is recalling 2,000 cases of ET-20 Anesthesia Extension Tubes distributed in Georgia due to potential kinking that may pose a health hazard.
Product
ET-20 Anesthesia Extension Tubes, 2.5 ml approximately, Sterile and Disposable, Wall Medical Inc., Made in China
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0747-2016·2016-02-10
Synthes Small Electric Drive Recalled for Malfunction and Unintended Operation
The Anspach Effort, Inc. is recalling 599 Synthes Small Electric Drive units because they may malfunction, fail to operate, or start unintentionally.
Product
Synthes Small Electric Drive (SED). For use in general traumatology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0719-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS BN/BV3000; Model Number: 72240 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0713-2016·2016-02-10
Philips Allura Xper FD20/20 Recall for Image Interpretation Error
Philips is recalling 13,297 Allura Xper FD20/20 systems because a software issue may cause still images to be mistaken for live images during medical procedures.
Product
Allura Xper FD20/20; Model Number: 722038 Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g. peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0708-2016·2016-02-10
Philips UNIQ and Allura Systems Recalled for Image Interpretation Error
Philips is recalling UNIQ and Allura imaging systems because still images may be misinterpreted as live images during medical procedures.
Product
UNIQ FD; Model Numbers: 722028 The Philips UNIQ is intended for use on human patients to perform: " Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0729-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images.
Product
INTEGRIS CV; Model Number: 722030 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0725-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura medical imaging systems because a software issue may cause still images to be misinterpreted as live images.
Product
INTEGRIS BV5000: Model Number: 72249 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0723-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be mistaken for live images during procedures.
Product
INTEGRIS BH5000; Model Number: 72247 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0701-2016·2016-02-10
Mindray Recalls Panorama Patient Monitoring Network Software Due to Restart Issue
Mindray is recalling Panorama Patient Monitoring Network software kits because the system may spontaneously restart, causing a temporary loss of monitoring.
Product
Panorama Patient Monitoring Network. Software Kit 0020-00-0205-19A, View Station Software Kit 0020-00-0206-16A, Work Station Software Kit 0020-00-0207-16A, Software Kit Upgrade TECH-00-910. The Panaroma Patient Monitoring Network is intended for use in a fixed location in…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0717-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Display Error
Philips is recalling INTEGRIS and Allura systems because a software issue may cause still images to be misinterpreted as live images.
Product
INTEGRIS H3000; Model Number: 72238 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0722-2016·2016-02-10
Philips INTEGRIS and Allura Systems Recalled for Image Interpretation Risk
Philips is recalling INTEGRIS and Allura medical imaging systems because software issues may cause still images to be misinterpreted as live images during procedures.
Product
INTEGRIS H5000; Model Number: 72246 The Philips INTEGRIS 3000 I 5000 system is intended for interventional and diagnostic vascular and neurovascular procedures. The Philips INTEGRIS Allura 9 Biplane system is intended for diagnostic cardiovascular, vascular and interventional…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0741-2016·2016-02-10
Horiba ABX PENTRA Lactic Acid Reagent Recalled for Interference
Horiba Instruments Inc. is recalling ABX PENTRA Lactic Acid CP reagents because N-acetylcysteine in patient blood can cause falsely low results.
Product
ABX PENTRA Lactic Acid CP ref. A11A01721 reagent is intended for the quantitative in vitro diagnostic determination of lactic acid in plasma by colorimetry. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis…
Category
Medical Device
Distribution
29 states
HighFDA (Devices)·Z-0733-2016·2016-02-10
Owens & Minor Recalls MediChoice Cohesive Bandages Due to Microbial Contamination
Owens & Minor is recalling MediChoice sterile cohesive bandages because testing revealed microbial contamination. The affected products were distributed nationwide.
Product
MediChoice Cohesive Bandages, One (1) roll of cohesive bandage per bag, thirty-six (36) bags per case [all model numbers have equivalent packaging]. General Hospital Use.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0743-2016·2016-02-10
Horiba ABX PENTRA Uric Acid CP Recalled for Interference
Horiba Instruments Inc is recalling ABX PENTRA Uric Acid CP assays because N-acetylcysteine in patient blood can cause falsely low results.
Product
ABX PENTRA Uric Acid CP ref. A11A01670 is an in vitro diagnostic assay for the quantitative determination of uric acid in human serum, plasma and urine based on the enzymatic determination of uric acid using a chromogenic system in the presence of peroxidase and uricase…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0732-2016·2016-02-10
JosNoe PS-500 Scope Warmer Recalled for Package Seal Damage
JosNoe Medical is recalling PS-500 Scope Warmers because damaged package seals may compromise sterility. The recall covers 1,008 boxes distributed in the US and Canada.
Product
PS-500 Scope Warmer; 10 units per box. Pre-heating scope for laparoscopy surgery.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0750-2016·2016-02-10
bioMérieux Recalls BacT/ALERT FA Culture Bottles Due to Shipping Exposure
bioMérieux is recalling 2,741 BacT/ALERT FA culture bottles because non-normal shipping conditions may have degraded the media, potentially affecting microbial detection performance.
Product
BacT/ALERT¿ FA, bioM¿rieux, Inc., Product Usage: BacT/ALERT¿ Culture Bottles are used with the BacT/ALERT¿ Microbial Detection System in qualitative procedures for enhanced recovery and detection of aerobic and facultative anaerobic microorganisms (bacteria and yeast).
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0739-2016·2016-02-10
Horiba Instruments Recalls ABX PENTRA Enzymatic Creatinine Reagent Due to Interference
Horiba Instruments Inc. is recalling ABX PENTRA Enzymatic Creatinine CP reagent because N-acetylcysteine in patient blood can cause falsely low results.
Product
ABX PENTRA Enzymatic Creatinine CP ref. A11A01907 reagent is intended for the quantitative in vitro diagnostic determination of creatinine in human serum, plasma and urine based on an enzymatic method of using a multi-step approach ending with a photometric end-point reaction.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0700-2016·2016-02-10
Smith & Nephew Recalls Oversized Biosure Ratchet Driver for Orthopedic Screws
Smith & Nephew is recalling nine Biosure Ratchet Drivers because they are oversized and may not fit screws properly or may cause screws to stick.
Product
Biosure Ratchet Driver, Product No: 72201888 For delivery and placement of orthopedic screws. Arthroscopic surgical instrument
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0699-2016·2016-02-10
Smith & Nephew Recalls Oversized Biosure Orthopedic Screw Drivers
Smith & Nephew is recalling 157 Biosure Drivers that are oversized and may fail to insert screws properly or cause screws to stick.
Product
Biosure Driver, Product No: 72201887 For delivery and placement of orthopedic screws. Orthopedic Manual Surgical Instrument
Category
Medical Device
Distribution
17 states
ModerateFDA (Devices)·Z-0757-2016·2016-02-10
Olympus TJF-Q180V Duodenoscope Recall for Forceps Elevator Mechanism Replacement
Olympus is voluntarily removing all TJF-Q180V duodenoscopes to replace the forceps elevator mechanism with a new design consistent with recent 510(k) specifications.
Product
Olympus TJF-Q180V flexible gastrointestinal Duodenoscope Product Usage: This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories, and other ancillary equipment for endoscopy and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0755-2016·2016-02-10
Siemens ADVIA Chemistry XPT Systems Recalled for Multiple Software Issues
Siemens Healthcare Diagnostics is recalling 87 ADVIA Chemistry XPT Systems due to software defects that may cause test failures, calibration errors, and system restarts.
Product
ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes at a throughput rate of both 1800 photometric tests per hour and 600 electrolyte…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0738-2016·2016-02-10
Horiba ABX PENTRA Cholesterol CP Reagent Recalled for Interference
Horiba Instruments Inc is recalling 216 units of ABX PENTRA Cholesterol CP reagent because N-acetylcysteine can cause falsely low results.
Product
The ABX PENTRA Cholesterol CP ref. A11A01634 is an in vitro diagnostic assay for quantitative determination of cholesterol in human serum and plasma based on an enzymatic photometric test (Trinders reaction). The assay is composed of a 99 ml mono-reagent cassette. Reagent is a…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0736-2016·2016-02-10
Instrumentation Laboratory Recalls HemosIL Plasminogen IVD Kits
Instrumentation Laboratory is recalling specific lots of HemosIL Plasminogen kits because they do not meet labeled stability claims.
Product
HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Category
Medical Device
Distribution
0 states

How to read this listing

Filters

31076–31100 of 40325