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

37751–37775 of 40325

HighFDA (Devices)·Z-1924-2013·2013-08-14
Siemens Recalls Dimension Tacrolimus Flex Reagent Cartridges Due to Low Recovery
Siemens Healthcare Diagnostics is recalling specific lots of Dimension Tacrolimus Flex reagent cartridges and calibrators because they may produce falsely low test results, potentially affecting medication dosing for transplant patients.
Product
Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage: The TACR method is an in vitro diagnostic test intended to quantitatively measure Tacrolimus in human whole blood on the Dimension clinical chemistry system. Measurements of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2013·2013-08-14
Siemens Dimension EXL TSH Reagent Cartridge Recall for Rare Variant Detection
Siemens Healthcare Diagnostics is recalling Dimension EXL TSH reagent cartridges because they fail to detect a rare TSH variant found in a small patient cluster.
Product
Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1881-2013·2013-08-14
Siemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra ReadyPacks because a rare variant of TSH is not detected by the test.
Product
ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF 04862625 - 2500T). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1892-2013·2013-08-14
ASO Leader Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling Leader Wound Closure Adhesive Surgical Tape Strips because the company cannot confirm the products are sterile.
Product
Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1893-2013·2013-08-14
Meijer Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling Meijer Wound Closure Adhesive Surgical Tape Strips because the manufacturer could not confirm the product's sterility.
Product
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1923-2013·2013-08-14
BD Vacutainer Luer Adapter Recalled for Potential Blood Leakage and Low Draw Volume
Becton Dickinson is recalling BD Vacutainer Multiple Sample and Direct Draw Luer Adapters due to potential blood leakage and low draw volume.
Product
BD Vacutainer Multiple Sample and Direct Draw Luer Adapter BD Franklin Lakes, NJ 07417 USA A sterile non-invasive device used to connect venous access devices such as needles, blood collection sets, ad infusion sets to blood collection tubes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1895-2013·2013-08-14
TopCare Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling TopCare Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
Product
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0834-2013·2013-08-14
Ventana Discovery Ultra Staining Systems Recalled for Waste Fluid Overflow Risk
Ventana Medical Systems is recalling 54 Discovery Ultra automated staining systems because waste fluid drainage may become restricted, leading to overflow and potential fluid migration.
Product
VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Research Use Only Product Usage: Research Use Only-The DISCOVERY ULTRA Advanced Staining System is intended to automatically stain histological or cytological specimens on microscope slides with…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1889-2013·2013-08-14
ASO Recalls Wound Closure Tape Strips Due to Sterility Concerns
ASO, LLC is recalling Discount Drug Mart wound closure adhesive tape strips because the company cannot confirm the product is sterile.
Product
Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1888-2013·2013-08-14
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns
ASO, LLC is recalling CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
Product
CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1930-2013·2013-08-14
Radiometer TCM4 Base Units Recalled for Electrical Safety Non-Compliance
Radiometer America Inc is recalling TCM4 series Base Units and Power Supplies because they do not comply with IEC 60601-1 Sub Clause 15B electrical safety standards.
Product
TCM4 series Base Units, and spare part Power Supply, Radiometer Medical ApS, Akandevej 21, Br¿nsh¿j, Denmark, www.radiometer.com. The devices are intended for continuous monitoring of carbon dioxide and oxygen partial pressures, oxygen saturation, and pulse rate.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1871-2013·2013-08-14
SpineFrontier Recalls Chameleon FacetFuse Drill Guides Due to Mechanical Interference
SpineFrontier, Inc. is recalling 13 Chameleon FacetFuse Drill Guides because denting and bending prevented proper surgical use.
Product
Drill Guide - Chameleon FacetFuse Fixation System, Model: 11-00028 Rev. A FacetFuse Drill Guides were designed to provide a concentric pathway for the drills and taps to access the bone while protecting the soft tissue from the cutting geometry of the drills/taps. In addition…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1911-2013·2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes are not updated correctly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EN. Part number: 414560. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1913-2013·2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Error
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 FR. Part number: 414562. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1872-2013·2013-08-14
Precision Dynamics Recalls Non-Sterile Viscot Surgical Skin Markers
Precision Dynamics Corporation is recalling 1,200 non-sterile Viscot surgical skin markers because they were mislabeled as sterile.
Product
Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot Part Number 143-100 Surgical Skin Markers are pen-like devices intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-1914-2013·2013-08-14
Biomerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
Biomerieux Inc. is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes are not updated properly when interfaced with a Laboratory Information System.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 IT. Part number: 414563. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1916-2013·2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for Cefovecin, Prulifloxacin, and Ceftaroline are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 NO. Part number: 414565. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1927-2013·2013-08-14
SpineFrontier Recalls Invue Split Driver Devices Due to Design Flaw
SpineFrontier, Inc. is voluntarily recalling 12 Invue Split Driver devices due to a device design issue. The recall covers units distributed nationwide.
Product
Invue Split Driver, Assembly with Handle, Model SI70006 Rev G. Used in conjunction with the Invue Anterior Cervical Plate System under 501(k) clearance number K121060. The Invue Driver is an instrument consisting of a Radel handle, a shaft and hexalobe-like tip with a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1925-2013·2013-08-14
Siemens Mass Creatine Kinase MB Isozyme Calibrator Recalled for Dissolution Issues
Siemens Healthcare Diagnostics is recalling 7,470 units of the Dimension Mass Creatine Kinase MB Isozyme Calibrator because the lyophilized cake may not fully dissolve.
Product
Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme Calibrator is an in vitro diagnostic product intended to be used to calibrate the Creatine Kinase MB Isozyme method for the Dimension(R) clinical chemistry system with…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1933-2013·2013-08-14
SpineFrontier Recalls Indus Invue Screw Caddies Due to Removal Difficulty
SpineFrontier, Inc. is recalling Indus Invue Screw Caddies because screws are difficult to remove from the device. The recall affects 13 units distributed in the US and Jamaica.
Product
Indus Invue Screw Caddy, Model: SI70097 The caddy holds, in an organized fashion within the case, a variety of shapes and sizes of plates and screws used during fixation of anterior cervical plates to provide stabilization during the development of spine fusions. There is an…
Category
Medical Device
Distribution
7 states
ModerateFDA (Devices)·Z-1907-2013·2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, V2S 6.01 RP5800-WES7 Media. Part number: 413861. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1920-2013·2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux Inc is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs are not updated correctly when interfacing with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 ZH. Part number: 414569. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1921-2013·2013-08-14
BioMérieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs are not updated properly when interfaced with Laboratory Information Systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit V2S RP5800XPE TO 6.01 WES7. Part number: 6201773. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1915-2013·2013-08-14
BioMérieux Vitek 2 Software Recall Due to Antibiotic Code Errors
BioMérieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three drugs are not updated correctly when interfaced with laboratory systems.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 JA. Part number: 414564. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1919-2013·2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 Systems Software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during a software upgrade.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01 EL, TR. Part number: 414568. The product is used with the VITEK 2 automated system which consists of instruments, software and reagent cards designed for the…
Category
Medical Device
Distribution
Distributed nationwide

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