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

37876–37900 of 40449

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
ModerateFDA (Devices)·Z-1929-2013·2013-08-14
Smith & Nephew Recalls R3 XLPE Acetabular Liners Due to Mislabeling
Smith & Nephew is recalling specific batches of R3 XLPE acetabular liners because some 60 mm and 62 mm units may be mislabeled with incorrect size markings.
Product
R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
Category
Medical Device
Distribution
13 states
ModerateFDA (Devices)·Z-1882-2013·2013-08-14
Siemens Dimension TSH Flex Reagent Cartridge Recall for Rare Variant Detection Failure
Siemens Healthcare Diagnostics is recalling Dimension TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.
Product
Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1908-2013·2013-08-14
BioMerieux Vitek 2 Software Recall for Interface Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because antibiotic codes for three specific drugs were not updated correctly during the software upgrade.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML1. Part number: 414537. 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-1876-2013·2013-08-14
Medtronic Mullins Transseptal Catheter Sheath Recall for Labeling Error
Medtronic is recalling specific lots of Mullins Transseptal Catheter Introducer Sheaths because packages labeled as 7F may contain 8F dilators.
Product
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1917-2013·2013-08-14
BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMérieux 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 PT. Part number: 414566. 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-1909-2013·2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes were not updated correctly during an upgrade, potentially affecting laboratory reporting.
Product
bioMerieux Vitek 2 Systems Software version 6.01 software, used with the VITEK 2 automated system. Kit, UPDT V2S 6.01ML2. Part number: 414538. 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-1910-2013·2013-08-14
BioMerieux Vitek 2 Software Version 6.01 Recalled for Interface Errors
BioMerieux is recalling Vitek 2 software version 6.01 because specific antibiotic codes 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 DE. Part number: 414539. 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-1918-2013·2013-08-14
BioMérieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMérieux is recalling Vitek 2 Systems Software version 6.01 because specific antibiotic codes 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 DA, SV. Part number: 414567. 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-1912-2013·2013-08-14
BioMerieux Vitek 2 Software Recall for Antibiotic Code Errors
BioMerieux 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, UPDT V2S 6.01 ES. Part number: 414561. 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-1884-2013·2013-08-14
Siemens TSH Reagent Cartridge Recall for Rare Variant Detection Failure
Siemens Healthcare Diagnostics is recalling Dimension Vista System TSH Flex Reagent Cartridges because a rare variant of TSH is not detected.
Product
Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin).
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-1873-2013·2013-08-14
Beckman Coulter AU5800 Clinical Chemistry Analyzer Recall for Labeling Defect
Beckman Coulter is recalling AU5800 Clinical Chemistry Analyzers because the diluted detergent tank lacks labeling for the on/off valve disposition.
Product
Beckman Coulter AU5800 Clinical Chemistry Analyzer, All Serial Numbers. An automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC), material and other accessories.
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-1820-2013·2013-08-07
DePuy LPS Lower Extremity Dovetail Intercalary Component Recall for Fracture Risk
DePuy Orthopaedics is recalling LPS Lower Extremity Dovetail Intercalary components due to a potential for fracture under certain physiological loads.
Product
LPS Lower Extremity Dovetail Intercalary component. Intended for use in replacement of the mid-shaft portion of the femur.
Category
Medical Device
Distribution
17 states
HighFDA (Devices)·Z-1847-2013·2013-08-07
Hospira Symbiq Infusion System Recalled for Secondary Audio Signal Failure
Hospira Inc. is recalling 2,791 Symbiq Infusion Systems because the secondary audio signal fails to activate. The devices were distributed across 22 US states.
Product
The Hospira Symbiq Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, or irrigation routes of administration.
Category
Medical Device
Distribution
22 states
HighFDA (Devices)·Z-1848-2013·2013-08-07
Siemens Luminos dRF Fluoroscopic X-Ray System Recalled for Software Error
Siemens is recalling four Luminos dRF Fluoroscopic X-Ray systems due to a software error that may cause the table to tilt and collide with the floor.
Product
Siemens Luminos dRF Fluoroscopic X-Ray system Fluoroscopic X-Ray system
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-1837-2013·2013-08-07
Omnicycle Elite Medical Exercise Equipment Recalled for Firmware Anomaly
Accelerated Care Plus is recalling 1,001 Omnicycle Elite units due to a firmware anomaly that may cause the equipment to operate at an incorrect speed in reverse mode.
Product
Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical purposes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1821-2013·2013-08-07
Synthes Synapse SD Drill Guide Recalled for Incorrect Etching
Synthes USA HQ, Inc. is recalling two Synapse SD Drill Guides with incorrect etching. The error could lead to the use of the wrong drill size during surgery.
Product
Synthes Synapse SD Drill Guide, Part Number SD389.477, Lot Number 6913900 Indicated for Hooks, Plate/Rods, Rods and Screws when intended to promote fusion of the cervical spine fusion of the cervical spine and occipitocervical junction (occiput-T3), the plate/rod, rod, hook…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1817-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Monitor Due to Blister Wound Risk
Sotera Wireless is recalling 90 ViSi Mobile Monitoring Systems because the chest sensor may cause blister wounds.
Product
ViSi Mobile Monitor, Catalog No. 92-10010 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-1832-2013·2013-08-07
Exactech Articulated Driver Recalled for Potential Disassembly During Use
Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.
Product
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1818-2013·2013-08-07
Sotera Wireless Recalls ViSi Mobile Chest Sensors for Blister Risk
Sotera Wireless is recalling 75 ViSi Mobile Chest Sensors because they may cause blister wounds on patients.
Product
ViSi Mobile Chest Sensor (3 lead-wire ECG, AAMI), Catalog No. 93-10014 The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients.
Category
Medical Device
Distribution
2 states

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37876–37900 of 40449