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

39676–39700 of 40356

ModerateFDA (Devices)·Z-0003-2013·2012-10-10
Beckman Coulter Recalls IMMAGE Rheumatoid Factor Reagent Due to False Results
Beckman Coulter is recalling specific lots of IMMAGE Rheumatoid Factor reagent because they may produce false abnormal results in patient samples.
Product
IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0001-2013·2012-10-10
Synthes MIRS Spinal Fixation Devices Recalled for Labeling Correction
Synthes is correcting labeling for MIRS spinal fixation devices to emphasize avoiding rod mis-alignment following reported complaints.
Product
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2072-2012·2012-10-10
Eos Imaging Recalls EOS X-ray Systems Due to Generator Failures
Eos Imaging Inc is recalling 12 EOS X-ray systems in the US because the anode controller board can fail, causing generator issues.
Product
EOS X-ray Medical Diagnostic , X-ray Equipment System Digital Radiography used in general radiographic examination.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2487-2012·2012-10-10
Stryker Orthopaedics Recalls Cone Body Trials Due to Metal Shavings
Stryker Howmedica Osteonics Corp. is recalling 10,983 Restoration Modular Cone Body Trials because metal shavings were found in the internal threaded portion.
Product
Stryker Orthopaedics Restoration Modular Cone Body Trials Stryker Ireland Carrigtwohill Industrial Estate Carrigtwohill County Cork, Ireland. The Cone Body Trials simulate the respective Cone Body implants and mate with the stem trials to assist the surgeon in assessing…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0005-2013·2012-10-10
Animas Insulin Pumps Recalled for Keypad Wear and Peeling
Animas Corporation is recalling insulin pumps due to keypad wear that may cause tearing or peeling. The recall covers 236,470 units distributed worldwide.
Product
IR1200, IR1250(IR1200 Plus), 2020 and One Touch(R) Ping(R) Insulin Pump glucose management system. The device is intended to deliver insulin therapy.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0007-2013·2012-10-10
Invuity Recalls Obsolete BriteField Illuminated Suction Devices
Invuity is recalling 197 obsolete BriteField Illuminated Suction Devices nationwide. The devices were not distributed after March 2011.
Product
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0002-2013·2012-10-10
Beckman Coulter PrepPlus Recalled for Reagent Level Sense Failures
Beckman Coulter is recalling the PrepPlus pipetting system because it may fail to warn users when reagent levels are low or out.
Product
COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0010-2013·2012-10-10
C.R. Bard Recalls Pediatric Foley Catheters with Incorrect Valve Cap Labeling
C.R. Bard is recalling 4,032 units of 8 Fr. Bardex Pediatric All-Silicone Foley Catheters because the valve cap displays an incorrect inflation volume of 10 ml instead of 5 ml.
Product
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0008-2013·2012-10-10
Gynex Electrosurgical Electrode Holder Recalled Due to Assembly Error
Gynex Corporation is recalling 19 boxes of electrosurgical electrode holders because an incorrect connector pin was attached during assembly, rendering the devices unusable.
Product
Sterile, single-use, disposable electrosurgical electrode holder. It connects the electrode to the foot activated electric generator. Label reads in part "***GYNEX*** Electrode Handpiece, Foot Activated*** Manufactured for GYNEX***" Gynex catalog number: 950 (Gynex REF…
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

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39676–39700 of 40356