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

27276–27300 of 27722

HighFDA (Devices)·Z-0006-2013·2012-10-10
US Endoscopy Raptor Grasping Device Recalled for Potential Jaw Failure
US Endoscopy Group Inc is recalling 1,153 Raptor grasping devices because the jaws may become stuck open if excessive force is applied while the catheter is coiled.
Product
Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2490-2012·2012-10-10
Stanley Tabs Professional Monitor Recalled for Alarm Failure
Stanley Security Solutions is recalling 176 Tabs Professional Monitor units because they may fail to sound an alarm, potentially increasing the risk of falls.
Product
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutions, Inc., Lincoln, NE. Designed to help reduce the risk of falls by alerting caregivers when a resident is leaving a bed, chair, room or wheelchair.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2437-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 268,022 units of the Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6035A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2435-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 104,355 units of the Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4548A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2462-2012·2012-10-03
Varian Eclipse Treatment Planning System Recalled for Dose Calculation Error
Varian is recalling Eclipse Treatment Planning Systems because a clock synchronization issue can cause incorrect dose calculations, potentially leading to under- or over-dosing of patients.
Product
Varian brand Eclipse Treatment Planning System, Model Number: H48; Eclipse 8.9 and 10.0 Reference/FSCA Identifier: CP-08922; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The Eclipse Treatment Planning System (Eclipse TPS) is used to…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2436-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 22,218 units of the Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 3.5 mm Universal Straight Single Use Loading Unit Product Code: DUET6035. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric surgery…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2439-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 135,712 units of the Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Articulating Single Use Loading Unit. Product Code: DUET6048A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2432-2012·2012-10-03
FDA Recalls Covidien Duet TRS Staplers Due to Injury Risk
The FDA is recalling 433,528 units of the Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Straight Single Use Loading Unit. Product Code: DUET4535. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2433-2012·2012-10-03
FDA Recalls Covidien Duet TRS Surgical Staplers Due to Injury Risk
The FDA is recalling 94,301 units of the Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 3.5 mm Universal Articulating Single Use Loading Unit. Product Code: DUET4535A. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2438-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 15,936 units of the Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 60 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET6048. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2434-2012·2012-10-03
FDA Recalls Covidien Duet TRS Stapler Units Due to Injury Risk
The FDA is recalling 4,867 units of the Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit because the device may injure adjacent anatomical structures.
Product
Covidien Duet TRS 45 4.8 mm Universal Straight Single Use Loading Unit. Product Code: DUET4548. Single Use Loading Unit (SULU) tissue reinforcement stapler. The Endo GIA Universal Staplers with Duet TRS reloads have applications in abdominal, gynecologic and pediatric…
Category
Medical Device
Distribution
0 states
SevereFDA (Devices)·Z-2459-2012·2012-10-03
Boston Scientific Z Flex 270 Steerable Sheath Recalled for Embolic Risk
Greatbatch Medical is recalling 787 units of Boston Scientific Z Flex 270 Steerable Sheaths because damaged internal liners could pose an embolic risk to patients.
Product
Boston Scientific, Z Flex 270, Steerable Sheath, Sterile EO, Rx only, Distributed by Boston Scientific Corporation, One Boston Scientific Place, Natick, MA 01760-1537, Manufactured by Greathbatch Medical, 2300 Berkshire Lane North, Minneapolis, MN 55441. To facilitate…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2465-2012·2012-10-03
Philips Digital Diagnost Mobile Detector Holder Recall for Insecure Fit
Philips is recalling 93 Mobile Detector Holders because the Wireless Portable Detector may not be fixed securely and could fall down.
Product
Philips Digital Diagnost-Mobile Detector Holder for Digital Diagnost (Single Detector, Dual Detector, Release 3) System codes: 712020, 712022, 712025 This system is used for making X-ray exposures for diagnostics.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2440-2012·2012-10-03
OPTI Medical Systems Recalls BP7561 B-Lac Cassettes for Altitude Bias
OPTI Medical Systems is recalling BP7561 B-Lac cassettes because PCO2 readings are biased at high altitudes.
Product
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2464-2012·2012-10-03
Siemens MRI Systems Recalled for Potential Coil Heating During Imaging
Siemens is recalling 370 MRI systems because the Flex Large 4 Coil can heat up in the electronic housing when positioned off-center.
Product
Siemens Magnetom Skyra, Verio, Spectra and Biograph MMR Nuclear Magnetic Resonance Imaging System and Tomographic Imager
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2451-2012·2012-10-03
Philips CT Systems Recalled Due to Potential Oil Accumulator Bolt Failure
Philips is recalling 112 Computed Tomography X-Ray Systems because a bolt may fail, causing the oil accumulator to detach from the tube housing assembly.
Product
Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images…
Category
Medical Device
Distribution
19 states
HighFDA (Devices)·Z-2466-2012·2012-10-03
KCI Recalls BariAir Therapy System Hand Pendent Due to Positioning Risk
KCI USA, Inc. is recalling 575 BariAir Therapy System Hand Pendants because patients may inadvertently place the bed into a pseudo-exit position, posing a safety risk.
Product
BariAir Therapy System The BariAir Therapy System is a risk management treatment system designed for large and / or difficult-to-manage patients. The BariAir Therapy System provides low air-loss pressure management therapy, pulsation, percussion, Turn Assist. flexible patient…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2463-2012·2012-10-03
DEXIS Imaging Suite Software Recall for Patient Data Mixing
Imaging Sciences International is recalling DEXIS Imaging Suite software versions 10.0.0 through 10.0.3 due to a defect that can mix patient records during database renumbering.
Product
DEXIS Imaging Suite - catalog number 1.008.7932, version numbers 10.0.0 through 10.0.3 Radiological Image Processing System
Category
Medical Device
Distribution
42 states
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

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