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

39951–39975 of 40480

ModerateFDA (Devices)·Z-2318-2012·2012-09-12
BD GeneOhm Cdiff Assay Recalled Due to Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 57 kits of the BD GeneOhm Cdiff Assay because of leakage in Cepheid SmartCycler reaction tubes.
Product
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C. difficile toxin gene…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2317-2012·2012-09-12
BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 68 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.
Product
BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***GeneOhm Sciences Canada, Inc. 2555 Boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2312-2012·2012-09-12
Capintec Captus 3000 Thyroid Uptake System Software Error Recall
Capintec is recalling Captus 3000 Thyroid Uptake Systems with specific software revisions due to a potential error in the 'Measure Liquid and Subtract Residual' protocol.
Product
Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement of organ uptake and circulating radioactivity.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2307-2012·2012-09-12
Princeton Biomeditech Recalls Poly stat Flu A & B Test Kits
Princeton Biomeditech Corp is recalling 103 kits of the Poly stat Flu A & B Test due to reports of dual positive results.
Product
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2319-2012·2012-09-12
Becton Dickinson Recalls BD GeneOhm Cdiff Assay Due to Tube Leakage
Becton Dickinson & Co. is recalling 32 kits of the BD GeneOhm Cdiff Assay because reaction tubes may leak. The product is distributed nationwide.
Product
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm Cdiff Assay is a qualitative in vitro diagnostic test for the direct detection of C.…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2316-2012·2012-09-12
BD GeneOhm MRSA ACP Assay Recalled for Leakage in Reaction Tubes
Becton Dickinson & Co. is recalling 38 kits of the BD GeneOhm MRSA ACP Assay due to leakage in Cepheid SmartCycler reaction tubes.
Product
BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5*** BD GeneOhm MRSA ACP Assay is a qualitative in vitro diagnostic test for the direct detection of…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2320-2012·2012-09-12
BD GeneOhm VanR Assay Recalled Due to Reaction Tube Leakage
Becton Dickinson is recalling BD GeneOhm VanR Assay kits because reaction tubes may leak. The recall affects 5 kits distributed nationwide.
Product
BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***GeneOhm Sciences Canada, Inc., 2555 boul, du Parc-Technologique, Quebec, QC, Canada G1P 4S5***. The BD GeneOhm VanR Assay is a qualitative in vitro test for the rapid detection of vancomycin-resistance…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2315-2012·2012-09-12
Toshiba MRI System Recalled for Potential Power Cable Terminal Issue
Toshiba American Medical Systems Inc. is recalling three MRI systems due to a potential problem with the position of the hold in the lug terminals on power cables.
Product
Toshiba Ultra-Short Magnetic Resonance Imaging System, EXCELART Vantage. MRT-1503/P5-Vantage MRI System. MR imaging.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2323-2012·2012-09-12
Trek Diagnostic Systems Recalls VersaTREK Windows Software Version 5.4.3
Trek Diagnostic Systems is recalling VersaTREK Windows Software Version 5.4.3 because positive test results may incorrectly revert to negative in the database.
Product
VersaTREK Windows Software, Version 5.4.3 is a component of the VersaTrek System. The Software CD will be individually packaged using a standard CD plastic case and placed into a standard CD mailer The VersaTREK System is for cultivating and recovering microorganisms…
Category
Medical Device
Distribution
38 states
LowFDA (Devices)·Z-2325-2012·2012-09-12
Steris recalls 77 packs of medical tubing due to failed process indicators
Steris Corporation is recalling 77 packs of medical tubing that failed process indicators. The tubing is used to maintain the sterility of enclosed medical devices.
Product
100 ft roll of tubing inside a cardboard box. Medical devices are sealed into the tubes prior to ethylene oxide sterilization. Tube maintains sterility of the enclosed medical devices until opened.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2314-2012·2012-09-12
Quality Electrodynamics Recalls 17 Non-Functional MRI Knee Coils
Quality Electrodynamics LLC is recalling 17 TxRx Knee 15 Coil 3T units because the coil identification code is incorrect, rendering the devices non-functional.
Product
TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce diagnostic images of the knee that can be interpreted by a trained physician.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2281-2012·2012-09-05
Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Systems
Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation Systems due to reports of warmth or heating at the implant site during charging.
Product
The Eon Mini Neurostimulation (IPG) System (Model 3788) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with 4, 8, and 16 electrode leads. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2272-2012·2012-09-05
Sunquest LabAccess Results Workstation Recalled for Incorrect Patient Data Filing
Sunquest Information Systems is recalling the LabAccess Results Workstation (LARS) because it may incorrectly file laboratory results to the wrong patient.
Product
Sunquest Laboratory LabAccess Results Workstation (LARS)
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2274-2012·2012-09-05
Atlas Spine Recalls Apelo Modular Screwdriver Due to Tip Breakage
Atlas Spine, Inc. is recalling the Apelo Modular Screwdriver because the tip may break and become implanted in the body or delay surgery.
Product
Apelo Modular Screwdriver labeled in part: "APELO PEDICLE SCREW SYSTEM***Modular Screwdriver***Atlas Spine, Inc.***www.AtlasSpine.com*** 1555 Jupiter Park Drive #4***Jupiter, Florida 33458***561-741-1108***Tissue Sleeve***MFG Date: XX/XX/XXXX***Lot #: XXXX***Weldment***MFG Date…
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2253-2012·2012-09-05
I-Flow Recalls ON-Q Pumps Due to Bolus Button Malfunction
I-Flow Corporation is recalling ON-Q pumps with ONDEMAND because the bolus button may fail to lock, causing patients to receive medication at higher-than-expected rates.
Product
ON-Q pump with ONDEMAND bolus button, ON-Q C-bloc with ONDEMAND; ON-Q C-bloc with Select a Flow and ONDEMAND Model/Reference #: 7000180, 7000181, 7000182, 7000367, 7000397, CB003, CB005, CB006, P400X1-7+5/60, P400X2-14+5/30, P400X5+5/60, and PMB01. Part Numbers: 101347100…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2301-2012·2012-09-05
Recall of DGHP RFA High-Power Grounding Pads Due to Burn Risk
Nellcor Puritan Bennett Inc. is recalling DGHP RFA High-Power grounding pads and electrode kits because foil degradation may cause electrical burns to patients.
Product
DGPHP RFA High-Power Single Use Grounding Pads and Cool-Tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads) The product is used during ablation surgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2280-2012·2012-09-05
Advanced Neuromodulation Systems Recalls Eon IPG for Heating Complaints
Advanced Neuromodulation Systems is recalling Eon IPGs due to reports of warmth or heating at the implant site during charging.
Product
Eon (Model 3716) IPG is a dual channel; 8-contact receiver designed to be connected to 4, 8, or 16 electrode leads or a lead extension. Product Usage: The Eon and Eon Mini Neurostimulation Systems are indicated as an aid in the management of chronic intractable pain of the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2251-2012·2012-09-05
GE OEC Surgical Navigation Systems Recalled for Unvalidated Headset Configuration
GE OEC Medical Systems is recalling 768 surgical navigation systems because the Inverted Headset Placement is not a validated configuration.
Product
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2266-2012·2012-09-05
Toshiba CT Systems Recalled for Potential Table Position Errors
Toshiba American Medical Systems is recalling 757 CT systems because a table control board defect may cause patients to be scanned at incorrect positions.
Product
Toshiba CT systems, Asteion and Aquilion, that are equipped with a PC based computer, or to those older systems (SGI based) that received an improved table by an upgrade purchase. This device is designed to produce cross-sectional images of a human body by reconstruction of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2303-2012·2012-09-05
Philips SureSigns VSi and VS2+ Patient Monitors Recalled for Mounting Defect
Philips is recalling SureSigns VSi and VS2+ patient monitors because they may not be properly secured to wall mounts and could fall.
Product
Philips SureSigns VSi/VS2+ patient monitors Model Part Numbers VSi/ 863275, 863276, 863277, VS2+ 863278, 863279. The SureSigns VS2+ vital signs monitor is for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2296-2012·2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units were distributed nationwide in the US.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 6.5 (16.51cm) Length***Reorder: ES0014M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2293-2012·2012-09-05
Medline Electrosurgical Electrodes Recalled for Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
Product
Product is labeled in part: "***MEDLINE***Extended PTFE Coated Blade with Extended Insulation 4.0 (10.16cm) Length***Reorder: ES0014AM***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2289-2012·2012-09-05
Medline PTFE Coated Needle Recall Due to Sterility Concerns
Unimed Surgical Products is recalling Medline Standard PTFE Coated Needles due to sterility concerns. The affected lots are distributed nationwide.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Needle 2.75" (6.99cm) Length***Reorder: ES0013***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a registered trademark of…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2304-2012·2012-09-05
Sendx Medical Recalls ABL80 FLEX Blood Gas Analyzers for Glucose Errors
Sendx Medical Inc is recalling ABL80 FLEX and ABL80 FLEX CO-OX analyzers because glucose measurements may be inaccurate and not reflect patient clinical conditions.
Product
ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) - pH Blood Gas and Electrolytes Analyzer System. Intended Use The ABL80 FLEX (with FLEX software) and ABL80 FLEX CO-OX (with CO-OX software) are portable, automated analyzers that measure pH, blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2012·2012-09-05
Unimed Recalls Medline Electrosurgical Electrodes Due to Sterility Concerns
Unimed Surgical Products is recalling Medline electrosurgical electrodes due to sterility concerns. The affected units are intended for cutting and coagulation of soft tissue.
Product
Product is labeled in part: "***MEDLINE***Standard PTFE Coated Blade with Extended Insulation 2.50 (6.40cm) Length***Reorder: ES0012M***Contents: 1 Each***SINGLE USE ONLY**latexfree***RX Only***STERILE EO***www.medline.com Manufactured for Medline Industries, Inc. MEDLINE is a…
Category
Medical Device
Distribution
Distributed nationwide

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39951–39975 of 40480