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

25676–25700 of 27686

SevereFDA (Devices)·Z-0485-2014·2013-12-25
Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Results
Abbott Diabetes Care is recalling specific lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.
Product
FreeStyle Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count UPC 6 99073 12050 2; Freestyle Blood Glucose Test Strips; for Institutional Use only 50 count: UPC 6 99073 70792 5 Manufactured by Abbott Diabetes Care Inc. Alameda, CA. The FreeStyle…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0472-2014·2013-12-25
GE Healthcare Recalls Multi Absorber Original Devices Due to Air Leakage
GE Healthcare is recalling Multi Absorber Original, Disposable devices due to a potential safety issue involving air leakage associated with the CO2 Multi Absorber.
Product
Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0487-2014·2013-12-25
Nephros SafeSpout Water Filters Recalled for Improper Medical Device Marketing
Nephros Inc. is recalling SafeSpout water filters because promotional materials made claims that marketed the non-medical products as medical devices.
Product
Nephros SafeSpout Manufacturer: Nephros Inc. 41 Grand Avenue, River Edge, NJ 07661 Assembled at : MEDICA 41036 Medolla, Italy Filters are packaged in a Tyvek pouch and then placed inside a cardboard box. 15 filters per box The Nephros SafeSpout and SafeShower are intended…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0540-2014·2013-12-25
Smiths Medical Recalls Medfusion 4000 Syringe Infusion Pumps for Electrical Shorting
Smiths Medical is recalling Medfusion 4000 Syringe Infusion Pumps because conductive fluids entering the AC power receptacle can cause electrical shorting, sparking, or flames.
Product
Medfusion¿ 4000 Syringe Infusion Pumps Medfusion¿ 4000 Syringe Infusion Pumps are designed for use in care areas for the administration of fluids requiring precisely controlled infusion rates. These pumps are indicated for use by healthcare professionals in the delivery of IV…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0486-2014·2013-12-25
Abbott FreeStyle Blood Glucose Test Strips Recalled for Erroneous Low Results
Abbott Diabetes Care is recalling certain lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood glucose readings.
Product
FreeStyle Lite Blood Glucose Test Strips; For in vitro diagnostic testing. 50 count; 100 count Product of Ireland; UPC 6 99073 70819 9; - 50 count UPC 6 99073 70822 9 - 50 count UPC 6 99073 71026 0 - 50 count UPC 6 99073 70827 4 - 100 count Manufactured by Abbott…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0490-2014·2013-12-25
Nephros Dual Stage Ultra Filter Brochure Recalled for Misleading Medical Claims
Nephros Inc is recalling brochures for its Dual Stage Ultra Filter because the materials promoted the product as a medical device.
Product
Nephros Dual Stage Ultra Filter (DSU) Brochure Document 60-3003 Revisions: 0, 1, 2 Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0539-2014·2013-12-25
Baxter ABACUS TPN Calculation Software Recalled for Data Corruption Risk
Baxter is voluntarily correcting ABACUS TPN software versions 2.0-3.0 because data corruption could cause patients to receive another patient's TPN order.
Product
ABACUS TPN Calculation Software, Baxa: 8300-0045 ABACUS CE (Calculator Edition), 8300-0046 ABACUS SE (Single-Workstation Edition), 8300-0047 ABACUS ME (Multi-Workstation Edition) ABACUS is a Windows¿ - based order entry TPN software application for comprehensive calculations…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2014·2013-12-25
Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results
Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.
Product
Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0524-2014·2013-12-25
GE Recalls InstaTrak and ENTrak Computer-Assisted Navigation Systems
GE OEC Medical Systems is recalling InstaTrak and ENTrak navigation systems due to potential safety issues.
Product
InstaTrak¿ 3500 Plus, ENTrakTM Plus, InstaTrak¿ 3500, ENTrakTM Computer-Assisted Navigation Systems (USA),
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0520-2014·2013-12-25
Intuitive Surgical Recalls Mega Needle Drivers for Potential Jaw Detachment
Intuitive Surgical is recalling Mega Needle Drivers for the da Vinci S and Si systems due to a potential risk of jaw insert detachment.
Product
Mega Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2014·2013-12-25
ASI Medical Recalls SEAC Advanced Dental Systems Due to Air Tank Rupture Risk
ASI Medical is recalling 337 SEAC Advanced Dental Systems because the miniature plastic air tank can potentially rupture.
Product
SEAC Advanced Dental System, Model A591561 The SEAC Advanced Dental System is a self-contained dental delivery system with a built-in air compressor,vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0536-2014·2013-12-25
Roche MagNA Pure 96 System Recalled for Potential Sample Mismatch
Roche Diagnostics is recalling 27 MagNA Pure 96 Systems due to a software issue that may cause sample mismatches when importing XML files.
Product
MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed…
Category
Medical Device
Distribution
12 states
HighFDA (Devices)·Z-0550-2014·2013-12-25
Qualigen Recalls FastPack Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling six FastPack immunoassay kits because a manufacturing defect may cause lower than expected test results.
Product
FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence assay for the determination of Vitamin D The FastPack Vitamin D Immunoassay is intended for the quantitative determination of FastPack Total PSA Immunoassay Chemilunescence assay for the…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0522-2014·2013-12-25
Mobility Unlimited Recalls KayserBetten IDA Beds Due to Door Joint Failure
Mobility Unlimited Inc. is recalling 33 KayserBetten model IDA beds because door joints may loosen or separate, causing doors to drop outward and potentially injure users.
Product
KayserBetten model IDA beds Product Usage: BED, AC-POWERED ADJUSTABLE HOSPITAL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0517-2014·2013-12-25
Siemens Recalls Dimension TACR Flex Reagent Cartridges for Stability Issues
Siemens is recalling Dimension TACR Flex reagent cartridges because reduced stability may cause inaccurate test results for transplant patients.
Product
Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension(R) clinical chemistry system. Measurements of Tacrolimus are used as an aid in the management…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0521-2014·2013-12-25
Intuitive Surgical Recalls Large Needle Drivers Due to Jaw Insert Detachment Risk
Intuitive Surgical is recalling Large Needle Drivers for the da Vinci S and Si systems because the jaw insert may detach during use.
Product
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0537-2014·2013-12-25
Remel Inc Recalls Streptex Kits Due to Potential False Negative Results
Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.
Product
Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0547-2014·2013-12-25
Qualigen Recalls FastPack Total PSA Immunoassay Kits Due to Manufacturing Defect
Qualigen Inc is recalling 182 units of the FastPack Total PSA Immunoassay because a manufacturing defect may cause lower than expected test results.
Product
FastPack Total PSA Immunoassay Chemilunescence assay for the determination of Total PSA. FastPack Total PSA Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of prostate-specific antigen (PSA) in human serum and plasma as an aid…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0518-2014·2013-12-25
Kimberly-Clark Epidural Pain Management Trays Recalled for Syringe Defect
Kimberly-Clark is recalling Single Shot Epidural Pain Management Trays because the included BD LOR Syringes may stall or stick.
Product
Kimberly-Clark Single Shot Epidural Pain Management Trays containing the BD LOR Syringe (BD Code 405198) Product Usage: The device is designed to provide regional anesthesia. The device may contain syringes, needles and drugs
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0525-2014·2013-12-25
Ortho-Clinical Diagnostics Recalls VITROS CA 125 II Calibrators
Ortho-Clinical Diagnostics is recalling VITROS CA 125 II Calibrators due to a positive shift in patient results.
Product
VITROS CA 125 II Calibrators For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, VITROS 3600 Immunodiagnostic System and VITROS 5600 Integrated System for the quantitative measurement of OC 125 defined antigen in human serum and plasma (EDTA or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0533-2014·2013-12-25
Integra Epidural Anesthesia Kits Recalled Due to Syringe Plunger Defect
Integra LifeSciences is recalling specific lots of epidural anesthesia kits because the included BD LOR syringe plunger may stall or stick.
Product
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0541-2014·2013-12-25
Siemens Dimension Vista Homocysteine Reagent Cartridge Recalled for Erratic Results
Siemens Healthcare Diagnostics is recalling Dimension Vista Homocysteine Flex Reagent Cartridges due to erratic quality control and patient sample recovery.
Product
Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnostic test for the quantitative measurement of total homocysteine in human serum, heparinized plasma and ETDA plasma on the Dimension Vista System. Measurements of homocysteine aid…
Category
Medical Device
Distribution
9 states
SevereFDA (Devices)·Z-0427-2014·2013-12-18
Cutera truSculpt Infrared System Recalled for Thermal Burn Risk
Cutera is recalling 451 truSculpt infrared systems because the device caused partial thickness thermal burns to the skin in two patients.
Product
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0458-2014·2013-12-18
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Recalled
Ethicon is recalling Stratafix Symmetric PDS Plus Knotless Tissue Control Devices due to reported tab failures and fascial dehiscences in lower abdominal incisions.
Product
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0477-2014·2013-12-18
Zimmer Trabecular Metal Total Ankle Tibial Base Component Recall
Zimmer, Inc. is recalling specific sizes of the Trabecular Metal Total Ankle Tibial Base Component due to potential elevated levels of manufacturing residue.
Product
Zimmer Trabecular Metal Total Ankle Tibial Base Component Sizes 1-6 Total ankle arthroplasty is intended to provide a patient with limited mobility by restoring alignment, reducing pain and preserving the flexion/extension movement within the ankle joint.The Zimmer…
Category
Medical Device
Distribution
Distributed nationwide

How to read this listing

Filters

25676–25700 of 27686