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

31176–31200 of 40449

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
ModerateFDA (Devices)·Z-0737-2016·2016-02-10
Bard Denali Intravascular Filters Recalled for Missing Contraindications
Bard Peripheral Vascular Inc is recalling 1,183 Denali intravascular filters because the instructions for use are missing critical contraindications regarding sepsis and nickel-titanium allergies.
Product
Denali Filter-Jugular/Subclavian DL950J Denali Filter-Femoral Delivery DL950F. Intravascular filters.
Category
Medical Device
Distribution
1 state
ModerateFDA (Devices)·Z-0754-2016·2016-02-10
Siemens ADVIA Centaur PSA Assay Recalled for High Dose Hook Effect Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur PSA Assay kits because they do not meet the High Dose Hook Effect expectation in the Instructions for Use.
Product
ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02676506/SMN 10310293 (500 test kit) Product Usage: This in vitro diagnostic assay is intended to quantitatively measure prostate-specific Antigen (PSA) in human serum using the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0749-2016·2016-02-10
bioMérieux Recalls BacT/ALERT SN Culture Bottles Due to Shipping Exposure
bioMérieux is recalling 2,741 BacT/ALERT SN culture bottles because non-normal shipping conditions may have degraded the media, potentially impacting microbial growth performance.
Product
BacT/ALERT¿ SN, 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-0742-2016·2016-02-10
Horiba Instruments Recalls ABX PENTRA Triglycerides Assay Due to Interference
Horiba Instruments Inc is recalling ABX PENTRA Triglycerides CP assays because N-acetylcysteine in patient blood can cause falsely low results.
Product
ABX PENTRA Triglycerides CP ref. A11A01640 is an in vitro diagnostic assay for the quantitative determination of triglycerides in human serum and plasma based on an enzymatic colorimetric test. It is composed of a 99 ml mono-reagent cassette. Reagent is a chemical solution with…
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0740-2016·2016-02-10
Horiba ABX PENTRA Glucose Reagent Recalled for NAC Interference
Horiba Instruments Inc is recalling ABX PENTRA Glucose reagents because N-acetylcysteine in patient blood can cause falsely low glucose results.
Product
ABX PENTRA Glucose PAP CP ref. A11A01668 reagent is intended for the quantitative in vitro diagnostic determination of glucose in human serum, plasma and urine using glucose oxidase method by colorimetry.
Category
Medical Device
Distribution
29 states
ModerateFDA (Devices)·Z-0731-2016·2016-02-10
Baxter RAPIDFILL Syringe Strips Recalled for Shelf Life Packaging Claim
Baxter is recalling RAPIDFILL Syringe Strips because the packaging claims a 12-month shelf life without supporting evidence.
Product
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0689-2016·2016-02-03
Cook Medical Recalls Zilver 518RX Vascular Stent Delivery Systems
Cook Medical is recalling 753 Zilver 518RX Vascular Stent delivery systems because a manufacturing defect may cause the catheter joint to separate during use.
Product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0690-2016·2016-02-03
Globalmed Logistix Recalls Lipogems SPA Aspiration Cannulae Due to Bending Risk
Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae because they may bend during procedures. The affected sterile cannulae were distributed to seven states.
Product
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-0694-2016·2016-02-03
EndoChoice Recalls Fuse 1C Colonoscopes Due to Bending Section Separation Risk
EndoChoice, Inc. is recalling 253 Fuse 1C Colonoscopes because the bending section may partially separate from the insertion tube, posing a risk of tissue trauma.
Product
Fuse 1C Colonoscope
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0651-2016·2016-02-03
Midmark Vantage Panoramic X-Ray System Recalled for Collimator Failure
Midmark Corp dba Progeny Inc is recalling 832 Vantage Panoramic X-Ray Systems because a primary collimator failure may cause unintentional movement without an error message.
Product
Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures.…
Category
Medical Device
Distribution
34 states
HighFDA (Devices)·Z-0693-2016·2016-02-03
Fresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect
Fresenius Medical Care is recalling 14,094 Liberty Cycler peritoneal dialysis machines because the door latch may not fully close, posing a risk of injury or treatment delay.
Product
Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
Category
Medical Device
Distribution
Distributed nationwide

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31176–31200 of 40449