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

39701–39725 of 40356

HighFDA (Devices)·Z-2469-2012·2012-10-03
ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets
ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.
Product
Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2461-2012·2012-10-03
Invacare Recalls I-Fit Shower Chairs Due to Quality and Adverse Event Data
Invacare is voluntarily recalling 21,168 I-Fit Shower Chairs (Models 9780, 9781, 9781-1) based on returned units and adverse event reports.
Product
Invacare¿ I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. These shower chairs are designed for individuals who require seating support when bathing or showering and provide comfort and safety in the bathtub.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2449-2012·2012-10-03
Terumo Advanced Perfusion System 1 Flow Module Recalled for Display Malfunction
Terumo is recalling 72 Flow Modules for the Advanced Perfusion System 1 because they may fail to display blood flow information or illuminate the LED indicator.
Product
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a qualified perfusionist who is experienced in the operation of Sarns or…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2470-2012·2012-10-03
Alcon 23G Ophthalmic Cannula Recall Due to Loose Fit
Alcon is recalling 23G non-valved trocar and infusion cannulas due to a loose fit that could cause detachment during ophthalmic surgery.
Product
This voluntary medical device correction is related to Alcon products that present a 23G nonvalved trocar cannula and infusion cannula together. These items are available as components within Accurus 23G TotalPLUS Pak, Accurus 23G Combined Procedure Packs (0.9mm and 1.1mm)…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2456-2012·2012-10-03
ConMed Linvatec Recalls Xenon Universal Light Source Devices
ConMed Linvatec is recalling 57 Xenon Universal Light Source units used for endoscopic illumination due to a Class II recall.
Product
***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light Source
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2450-2012·2012-10-03
Abbott Vascular Recalls Armada 35 PTA Catheters Due to Inflation Issues
Abbott Vascular is recalling Armada 35 and Armada 35 LL PTA Catheters because some devices may have difficulty inflating or deflating.
Product
Armada 35/ Armada 35 LL PTA Catheters. The device is intended for dilatation of lesions in the vasculature.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2468-2012·2012-10-03
Toshiba Aquilion One CT System Recalled for Abnormal Analysis Results
Toshiba American Medical Systems is recalling three Aquilion One CT systems because the SureStart function may fail, leading to abnormal cerebral blood flow analysis results.
Product
TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2447-2012·2012-10-03
Applied Medical Recalls Biliary Catheters Due to Packaging Particulate Matter
Applied Medical is recalling specific lots of biliary catheters because packaging particulate matter may reside on the product.
Product
Biliary Catheters (Models A47XX and CB0XXXXX): Model Numbers & Description: A4752, SYNTEL BILIARY 5F-23CM CATHETER; A4754, SYNTEL BILIARY 5F-40CM CATHETER; A4762, SYNTEL BILIARY 6F-23CM CATHETER; CB052308, SYNTEL BILIARY 5F-23CM CATH; CB054008, SYNTEL BILIARY 5F-40CM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2455-2012·2012-10-03
ConMed Linvatec Recalls Xenon Light Sources for Endoscopic Procedures
ConMed Linvatec is recalling LS7700 and LS7600 Xenon Light Sources used to illuminate endoscopes during medical procedures.
Product
***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light Source
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2452-2012·2012-10-03
Hologic Fluoroscan Mini C-Arm Recalled for Flipped DICOM Images
Hologic is recalling Fluoroscan Mini C-Arm devices with InSight2 software versions 4.0 and 4.0.1 because DICOM images stored in PACS may be flipped 180 degrees.
Product
Hologic Fluoroscan Mini C-Arm Model with InSight2, Software version 4.0 and 4.0.1 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2458-2012·2012-10-03
Integra Limited Recalls Mayfield Horseshoe Gel Pads Due to Packaging Error
Integra Limited is recalling Mayfield Horseshoe Gel Pads because left and right pads were incorrectly packaged. No patient injuries or surgical delays were reported.
Product
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2442-2012·2012-10-03
Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because the products are incorrectly labeled.
Product
Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Balloon Length/mm 15 Usable Catheter Length/cm 150***Lot 50026688***2013-09***Cordis***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***Sterile***EO***Method of Sterilization…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2453-2012·2012-10-03
Hologic Fluoroscan Mini C-Arm Software Recall for Image Orientation Errors
Hologic is recalling Fluoroscan Mini C-Arm devices with specific InSight software versions because DICOM images may be flipped 180 degrees when stored in PACS systems.
Product
Hologic Fluoroscan Mini C-Arm Model with InSight- FD Software Version 5.0.1and 5.0.2 The device is a Mini C-arm Fluoroscopic Imaging System designed to provide -physicians with general fluoroscopic visualization of a patient, including but not limited to surgical orthopedic…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2472-2012·2012-10-03
Ev3 Neurovascular Recalls Mislabeled Marathon Flow Directed Micro Catheters
Ev3 Neurovascular is recalling 23 units of Marathon Flow Directed Micro Catheters because one lot may have been mislabeled.
Product
Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The Marathon Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2457-2012·2012-10-03
Integra Limited Recalls Mispackaged MAYFIELD Horseshoe Gel Pads
Integra Limited is recalling 11 MAYFIELD Horseshoe Gel Pads from Lot 0938990 because left and right pads were incorrectly packaged. No patient injuries were reported.
Product
The MAYFIELD¿ Horseshoe Gel Pads are used in conjunction with the MAYFIELD¿ Base Units and MAYFIELD¿ Swivel Adaptors for neurosurgeries in the prone or supine positions. Those devices provide cranial stability and immobility for various craniotomies and spinal procedures. The…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2443-2012·2012-10-03
Terumo Advanced Perfusion System 1 Flow Pod Recall for False Alarms
Terumo is recalling 150 Advanced Perfusion System 1 Flow Pods due to a circuit board defect that causes false back flow alarms when tubing is absent.
Product
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when used by a…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2446-2012·2012-10-03
Applied Medical Recalls Vascular Catheters Due to Packaging Particulate Matter
Applied Medical Resources Corp is recalling specific lots of Vascular Catheters because packaging particulate matter may reside on the product.
Product
Embolectomy Catheters (Models A44XX, A4FXX, CE0XXXST, and CE0XXX): Model Numbers & Description: A4402, 3F-40CM, SYNTEL RT-EMB; A4403, 3F-80CM, SYNTEL RT-EMB; A4404, 4F-40CM, SYNTEL RT-EMB; A4405, 4F-80CM, SYNTEL RT-EMB; A4406, 5F-80CM, SYNTEL RT-EMB; A4407, 6F-80CM…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2467-2012·2012-10-03
K-Y Liquibeads Vaginal Moisturizer Recalled for Regulatory Compliance
Johnson & Johnson is voluntarily recalling K-Y Liquibeads Vaginal Moisturizer to address FDA concerns regarding the product's medical device clearance status.
Product
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2441-2012·2012-10-03
Cordis Recalls Sleek OTW PTA Catheters Due to Incorrect Labeling
Cordis Corporation is recalling specific lots of Sleek OTW PTA Dilatation Catheters because they are incorrectly labeled.
Product
Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon Length/mm***15***Usable Catheter Length/cm***150*** Lot 50027149***2013-09***Cordis*** Sleek***OTW***REF Cat. No. 426-1201X***PTA Dilatation Catheter***Cordis***Johnson Johnson Company***LOT Lot No.…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-2448-2012·2012-10-03
Applied Medical Recalls Irrigation Catheters Due to Packaging Particulate Matter
Applied Medical Resources Corp is recalling specific lots of irrigation catheters because packaging particulate matter may reside on the product.
Product
Irrigation Catheters (Models IRR-XXX-XX): Model Numbers & Description: IRR-023-10F,CATHETER IRRIGATION 10F 23CM; IRR-080-4F, CATHETER, IRRIGATION 4F 80CM; IRR-080-6F, CATHETER, IRRIGATION 6F 80CM. Irrigation Catheters are indicated for irrigation in the peripheral…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2460-2012·2012-10-03
Alere Triage TOX Drug Screen 9 Panel Recalled for Meter Calibration Issues
Alere San Diego is recalling 591 kits of the Alere Triage TOX Drug Screen 9 Panel because code chips may not set threshold ranges correctly in meters.
Product
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402. The Alere Triage TOX Drug Screen is a fluorescence immunoassay intended to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2471-2012·2012-10-03
Ev3 Neurovascular Recalls Mislabeled UltraFlow Micro Catheters
Ev3 Neurovascular is recalling 36 UltraFlow HPC Flow Directed Micro Catheters because one lot may have been mislabeled.
Product
UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usage: The UltraFlow HPC Flow Directed Micro Catheter is intended to access peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2444-2012·2012-10-03
RaySearch SharePlan Software Recalled for Unexpected Import Behavior
RaySearch Laboratories is recalling SharePlan 1.1 software due to unexpected behavior when importing specific files. The issue has not caused patient mistreatment.
Product
SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10). Manufacturing name RayAutoplan, aka t-RayAutoplan, commercial name (TomoTherapy) SharePlan Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment…
Category
Medical Device
Distribution
8 states
LowFDA (Devices)·Z-2445-2012·2012-10-03
Trinity Biotech Captia VZV IgG Kits Recalled for Positive Control Issues
Clark Laboratories is recalling 810 Captia VZV IgG kits because the positive control ran high out of its assigned range.
Product
Trinity Biotech, Captia VZV IgG. Product code 2325600: 96 Tests; product code: 2325601: 480 tests. For in vitro diagnostic use. Intended for the detection and quantitative determination of IgG antibody to VZV in human sera.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2454-2012·2012-10-03
Neomend Recalls Progel Pleural Air Leak Sealant Due to Incorrect Expiration Date
Neomend Inc is recalling 95 units of Progel Pleural Air Leak Sealant because the product was labeled with an incorrect expiration date.
Product
Progel Pleural Air Leak Sealant, Model #: PGPS002 Lot #: 111202-002 Product Usage: The Progel Pleural Air Leak Sealant is indicated for application to visceral pleura during an open thoracotomy after standard visceral pleural closure with, for example, sutures or staples…
Category
Medical Device
Distribution
Distributed nationwide

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39701–39725 of 40356