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

37476–37500 of 40325

HighFDA (Devices)·Z-2163-2013·2013-09-18
B. Braun Outlook ES Infusion Pumps Recalled for Key Panel Failure
B. Braun Medical Inc. is recalling Outlook ES Safety Infusion Systems because the HOLD button may fail to function due to intermittent circuitry contact.
Product
Outlook ES pump is intended for use with B. Braun Medical Inc. Horizon Pump IV Sets. Used to regulate the flow of primary and secondary fluids when positive pressure is required. The infusion system is capable of delivering fluid from a negative head height (when the IV fluid…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2192-2013·2013-09-18
BD Microtainer Quikheel Lancet Recalled for Failure to Retract
Becton Dickinson is recalling BD Microtainer Quikheel Lancets because they may not retract after use, creating a risk of exposure to used sharps.
Product
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becton, Dickinson and Company, Franklin Lakes, NJ 07417 USA Made in USA. Used to perform heel sticks for the purpose of collecting skin puncture blood.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-2170-2013·2013-09-18
Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
Product
ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2176-2013·2013-09-18
Leica Surgical Microscope Recall Due to Brake Failure During Installation
Leica Microsystems is recalling five surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
Product
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2187-2013·2013-09-18
Spine Wave Recalls Lumbar Intervertebral Fusion Implants Due to Material Error
Spine Wave, Inc. is recalling 17 units of the StaXx IB Convex Expandable Implant because the superior endplate was manufactured from a different polymer than specified.
Product
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. Indicated for intervertebral body fusion procedures in skeletally mature patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2195-2013·2013-09-18
Sybron Recalls AOA Mini RPE Screw Assemblies Due to Incomplete Welds
Sybron Dental Specialties is recalling 1,091 AOA Mini RPE Screw Assemblies because they may have incomplete welds. These components are used in orthodontic devices like Herbst and MARA appliances.
Product
AOA Mini RPE Screw Assembly , a component of Herbst, MARA and Fixed Metal devices. Product Usage: AOA Mini RPE Screw Assembly is a component of Herbst, MARA and Fixed Metal devices; removable functional appliances that are to modify the growth of the jaws in a prescribed…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2177-2013·2013-09-18
Leica Surgical Microscope Recall Due to Axis Brake Failure
Leica Microsystems is recalling 28 surgical microscopes because the Z-axis and/or AB and C-axis brakes failed during installation.
Product
Surgical microscope The device is used to improve the visibility of objects through magnification and illumination and can be applied for observation and documentation and for human veterinary medical treatment.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2161-2013·2013-09-18
GE Healthcare Recalls Tec 6 Anesthesia Vaporizers Due to Leak Detection Issue
GE Healthcare is recalling Tec 6 and Tec 6 Plus anesthesia vaporizers because the pre-operative leak test may fail to detect leaks caused by seal wear.
Product
Tec 6 continuous Flow Vaporizer and Tec 6 Plus Anesthesia Vaporizer. The Datex-Ohmeda Tec 6 Plus and Tec 6 Plus NAD Variant is an electronic vaporizer which delivers the anesthetic agent desflurane. The Tec 6 Plus attaches only to Datex-Ohmeda anesthesia machines equipped…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2013·2013-09-18
Monoject Heparin Lock Flush Syringes Recalled for Potential Non-Sterile Water
FDA is recalling Monoject 10 Units/mL Heparin Lock Flush syringes because they may contain non-sterile water while labeled as saline or heparin.
Product
Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Product ID: 8881580125 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2171-2013·2013-09-18
Siemens ADVIA Centaur Folate Reagent Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling 488 units of ADVIA Centaur Folate reagent due to calibration failures and quality control shifts.
Product
ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2167-2013·2013-09-18
Xlumena NAVIX Access Device Recalled for Catheter Fracture Risk
Xlumena is recalling 148 units of the NAVIX Access Device because a complaint investigation found the catheter can fracture at the distal end under load.
Product
Xlumena brand NAVIX Access Device, Model/Catalogue Number: NVX-10-03, Part Number: FG-00666, Product is manufactured and distributed by Xlumena, Inc., Mountain View, CA The NAVIX Access Device is a multi-lumen balloon catheter with a trocar, anchor balloon, and dilation…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-2173-2013·2013-09-18
Roche Recalls cobas 4800 HPV Test Kits Due to Formulation Error
Roche Molecular Systems is recalling specific lots of cobas 4800 HPV test kits because a formulation error was identified during the manufacture of the Master Mix reagent.
Product
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway 202 South Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 USA The cobas¿ HPV Test is a qualitative in vitro test for the detection of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2193-2013·2013-09-18
CareFusion Recalls Thoracentesis Trays Due to Catheter Occlusion Risk
CareFusion is recalling Thoracentesis and Safe-T Thoracentesis Trays because the included catheters may occlude, potentially delaying medical procedures and causing patient complications.
Product
*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareFusion; 1500 Waukegan Road; McGaw Park, IL 60085 USA; *** 2) Cat. 4341BSDF; Qty. 10; Safe-T Thoracentesis Tray; With Catheter and Sharps Injury Protection; Drug Free; CareFusion; 1500 Waukegan Road…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2169-2013·2013-09-18
Siemens ADVIA Centaur Folate Test Kits Recalled for Calibration Failures
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate test kits due to calibration failures and significant negative shifts in quality control and patient results.
Product
ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the quantitative determination of folate in serum or red blood cells.
Category
Medical Device
Distribution
46 states
HighFDA (Devices)·Z-2191-2013·2013-09-18
Lumenis Vision One Laser System Recalled for Unintended Laser Exposure
Lumenis is recalling three Vision One Laser Systems due to a potential for unintended laser exposure to the user.
Product
Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-2166-2013·2013-09-18
B. Braun Recalls Outlook Safety Infusion System Burette Sets
B. Braun Medical is recalling 900 Outlook Safety Infusion System Burette Sets because one injection site and valve were assembled upside down.
Product
Outlook Safety Infusion System Burette Set. For intravenous fluid administration.
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-2189-2013·2013-09-18
Edwards Lifesciences Recalls FloTrac Sensor Due to Packaging Error
Edwards Lifesciences is recalling 35 units of the FloTrac Sensor Model MHD85 because incorrect packaging configuration prevents validation of the product's sterility.
Product
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2162-2013·2013-09-18
Medical Indicators Recalls Tempa DOT Single-Use Clinical Thermometers
Medical Indicators, Inc. is recalling Tempa DOT single-use clinical thermometers due to potential mislabeling. The recall affects 111,800 boxes distributed nationwide.
Product
Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A. by Medical Indicators, Inc. 16 Thomas J Rhodes Industrial Drive, Hamilton, NJ 08619 USA Phone 1.888.737.1601 www.medicalindicators.com Per 3M website (this product line was recently bought by…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2190-2013·2013-09-18
HemoCue Glucose 201 Microcuvettes Recalled for Punctured Packaging
HemoCue AB is recalling HemoCue Glucose 201 Microcuvettes because some single-pack pouches were found to be punctured during a complaint investigation.
Product
HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. The HemoCue Glucose 201 Microcuvettes are designed for use with the HemoCue Glucose 201 Analyzer and the HemoCue Glucose 201 DM Analyzer. Quantitative determination of glucose in whole blood using a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2174-2013·2013-09-18
Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps
Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month shelf life.
Product
STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2165-2013·2013-09-18
Baxa Vial Adapter Recall for Incorrect Expiry Date
Baxter Healthcare is voluntarily recalling one lot of Baxa Vial Adapters due to an incorrect expiry date.
Product
Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Single Use. Product Code H93890. Used as a needleless access device for reconstitution and drug transfer.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2145-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall covers 660 units distributed worldwide.
Product
LeGoo¿ Endovascular Occlusion Gel- 0.5 mL LeGoo with 3 Cannula Pouch Product Number: LG50 LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme Corporation is recalling LeGoo Endovascular Occlusion Gel because the product contains particulates (fibers). The recall affects 220 units distributed worldwide.
Product
LeGoo Endovascular Occlusion Gel 1.0 mL Product Number: LG100IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2013·2013-09-11
Stelkast Recalls Distal Femoral Augments Due to Sterility Breach
Stelkast Co is recalling 11 units of SC2316 Distal Femoral Augments with Screws due to a breach of sterility in the packaging.
Product
SC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2154-2013·2013-09-11
Genzyme Recalls LeGoo Endovascular Occlusion Gel Due to Particulates
Genzyme is recalling 110 units of LeGoo Endovascular Occlusion Gel 0.5 mL because the product contains particulates (fibers). The recall covers all lot codes distributed worldwide.
Product
LeGoo Endovascular Occlusion Gel 0.5 mL Product Number: LG50IT LeGoo is a water-soluble, biocompatible polymer with reverse thermo-sensitive properties allowing it to be injected as a soft viscoelastic gel that forms an elastic plug within the vessel. LeGoo is indicated for…
Category
Medical Device
Distribution
Distributed nationwide

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