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

40251–40275 of 40480

ModerateFDA (Devices)·Z-2028-2012·2012-07-25
Integra Jarit Take-Apart Endoscopic Instruments Recalled for Component Defect
Integra Limited is recalling 108 Take-Apart Endoscopic Instruments because internal shaft components were out of specification.
Product
Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments. Integra(TM) Jarit(R) Take-Apart Endoscopic Instruments are intended for use in laparoscopic gynecological surgery and other operative procedures under endoscopic observations. For use when a rigid endoscopic instrument…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2013-2012·2012-07-25
Abbott Molecular Bar Code Scanner User's Guide Recalled for Incorrect Bar Codes
Abbott Molecular is recalling the Bar Code Scanner User's Guide because incorrect bar codes may prevent proper language configuration of the scanner.
Product
Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended…
Category
Medical Device
Distribution
5 states
ModerateFDA (Devices)·Z-2031-2012·2012-07-25
Becton Dickinson Recalls BD Gram Stain Kits Due to Staining Artifacts
Becton Dickinson is recalling 539 BD Gram Stain Kits because increased artifacts may interfere with the distinction between microorganisms.
Product
BD Gram Stain Kit, containing 1- 250 mL bottle of Gram Crystal Violet, and additional reagents: Gram Iodine (Stabilized), Gram Decolorizer, Gram Safranin. Gram Stain Kits and Reagents are used to stain microorganisms from cultures or specimens by the differential Gram…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2008-2012·2012-07-25
DeRoyal Recalls Surgical Kits Due to Missing Protective Tape
DeRoyal Industries is recalling 303 custom surgical kits and trays because clear protective tape was not applied during manufacturing.
Product
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2030-2012·2012-07-25
Sigma Recalls Infusion Pump Master Drug Library Editor Software
Sigma issued a safety alert for the SIGMASpectrum Infusion Pump Master Drug Library Editor software because it may create drug libraries that do not reflect common clinical practices.
Product
SIGMASpectrum Infusion Pump Master Drug Library (MDL) Editor software. Product Usage: A customized in-house library of all IV and epidural drugs, along with their safe delivery parameters.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1980-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling Pathfinder NXT Fixed Percutaneous Rod Holders because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: The rod is held by the instrument for inserting and guiding into the screw heads via percutaneous delivery during…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1931-2012·2012-07-18
Alere Triage BNP Kits Recalled for Potential Inaccurate Heart Failure Results
Alere San Diego, Inc. is recalling 30,083 Triage BNP kits nationwide due to decreased precision that may cause unpredictable false positive or negative results.
Product
Alere Triage BNP PN 98000XR Intended to be used as an aid in the diagnosis and assessment of severity of congestive heart failure (also referred to as heart failure).
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1925-2012·2012-07-18
Maquet FLOW-i Anesthesia System Recalled for Technical Alarm Issue
Maquet is recalling 284 FLOW-i Anesthesia Systems because a technical alarm may be generated if the MAN/AUTO switch is not fully engaged.
Product
FLOW-I Anesthesia System The system is intended for use in administrating anesthesia while controlling the entire ventilation for patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1983-2012·2012-07-18
Advanced Neuromodulation Systems Recalls Eon Mini Neurostimulation Devices
Advanced Neuromodulation Systems is recalling Eon Mini Neurostimulation devices due to a workmanship issue that can cause loss of communication or recharging, resulting in loss of pain relief.
Product
Eon Mini Neurostimulation (IPG) System (Model 3788); The product is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1981-2012·2012-07-18
Zimmer Recalls Pathfinder NXT Fixed Percutaneous Rod Holder Due to Cracking
Zimmer, Inc. is recalling the Pathfinder NXT Fixed Percutaneous Rod Holder because the tip may crack or break during surgery.
Product
Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile. Product Usage: PathFinder NXT is a minimally invasive pedicle screw system. The PathFinder NXT System consists of various screws and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1985-2012·2012-07-18
GE OEC InstaTrak 3500 Plus Surgical Navigation System Software Recall
GE OEC Medical Systems recalled 86 InstaTrak 3500 Plus surgical navigation systems due to software-related issues. The recall was initiated in 2006 but recently classified by the FDA due to administrative delays.
Product
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1930-2012·2012-07-18
Alere Triage Profiler SOB Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 5,013 kits of the Triage Profiler SOB Panel because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Alere Triage Profiler SOB Panel PN 97300 Used for the determination of creatine kinase MB, myoglobin, troponin I, B-type natriuretic peptide, and cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1929-2012·2012-07-18
Alere Triage Cardiac Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 6,044 kits of the Alere Triage Cardiac Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage Cardiac Panel PN 97000HS Used for the quantitative determination of creatine kinase MD (CK--MB), myoglobin and troponin I in EDTA anticoagulated whole blood or plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1928-2012·2012-07-18
Alere Triage CardioProfiler Panel Recalled for Decreased Precision
Alere San Diego, Inc. is recalling 16,962 kits of the Alere Triage CardioProfiler Panel due to decreased precision that may cause false positive or negative results.
Product
Alere Triage CardioProfiler Panel PN 97100CP Used for the quantitative determination of creatine kinase MB, myoglobin, troponin I and B-type natriuretic peptide in EDTA anticoagulated whole blood and plasma specimens.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1932-2012·2012-07-18
Alere Triage D-dimer Kits Recalled for Decreased Precision
Alere San Diego is recalling 1,972 Triage D-dimer kits because certain lots may have decreased precision, potentially leading to false positive or negative results.
Product
Triage D-dimer PN 98100 Used as an aid in the assessment and evaluation of patients suspected of having disseminated intravascular coagulation or thromboembolic events including pulmonary embolism.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2001-2012·2012-07-18
superDimension Systems Software Recall Due to Locatable Guide Malfunction
superDimension, Inc. is recalling Systems with Software Version 4.0-4.9 because they fail to recognize the Locatable Guide.
Product
superDimension Systems AAS00016-xx with Software Version 4.0-4.9. Indicated for use for displaying images of the tracheobronchial tree to aid the physician in guiding endoscopic tools or catheters in the pulmonary tract and to enable marker placement within soft lung tissue.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1989-2012·2012-07-18
GE Axcess Cranial Screw Recalled Due to Breakage During Insertion
GE Healthcare is recalling 15 kits of Axcess Cranial Screws because they may break during insertion, posing a potential health hazard.
Product
The Axcess Cranial Screw (sometimes referred to as the Axcess Cranial Pin) is a self-tapping, self-drilling screw and is an accessory used in conjunction with the Axcess Cranial Tri-Pin Kit. The Axcess Bone (Cranial) Pin is intended to be used when rigid fixation of a…
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1967-2012·2012-07-18
Edwards Lifesciences Recalls Rigid Suction Wands Due to Tip Detachment Risk
Edwards Lifesciences is recalling Rigid Suction Wands (models S033 and SPC2081) because the plastic tip may detach during use.
Product
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and therefore there is little risk of intravascular…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2012·2012-07-18
Drager PT 4000 Phototherapy System Recalled for Incorrect Fuse Rating
Draeger Medical Systems is recalling 65 Drager PT 4000 Phototherapy Systems because they contain a 16 Amp fuse instead of the specified 1.6 Amp fuse, posing a risk of overheating.
Product
Drager PT 4000 Phototherapy System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2012·2012-07-18
Civco VirtuTRAX Electromagnetic Sensor Recall Due to Calibration Error
Civco Medical Instruments is recalling 24 VirtuTRAX Instrument Navigator kits because incorrect sensor calibration may cause variability in projected needle paths during ultrasound procedures.
Product
CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose driveBAY, trakSTAR, electromagnetic sensor (8mm) with VirtuTRAX Instrument navigator and (8.9 tapered to 1.3 x 147cm) telescopically-folded CIV-Flex sensor covers (5), Ref. 610-1080. The firm name on…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1977-2012·2012-07-18
Abbott i-Stat Analyzer Recall for Excessive Heat in Battery Area
Abbott Point of Care is recalling i-Stat Analyzers because the battery area can become uncomfortably hot to touch. This is a recall extension.
Product
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540 Model 200. The 37 degree tests for sodium, potassium, ionized calcium, hematocrit, pH, PCO2, PO2, and the i-Stat 200 analyzer as port of the i-Stat System, are intended for use in the in vitro quantitization…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1946-2012·2012-07-18
Argon Safedraw Venous Close Loop System Recalled for Pouch Seal Defect
Argon Medical Devices is recalling 10 Safedraw Venous Close Loop System blood sampling sets in Missouri due to a potential pouch seal defect that may compromise the sterile barrier.
Product
Safedraw Venous Close Loop System, Blood Sampling Set, packaged in a tyvek bag, Model/Part Number 688695, Argon Critical Care Systems, Singapore Pte. Ltd., 198 Yishun Avenue 7, Singapore 768028. The blood sampling set is intended to be used for closed-loop blood sampling from…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1954-2012·2012-07-18
CIVCO General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 100 CIVCO General Purpose Sensors because incorrect calibration may cause variability in the projected position of the needle path.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 610-1066. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1953-2012·2012-07-18
Civco General Purpose Sensor Recalled for Calibration Errors
Civco Medical Instruments is recalling 30 kits of General Purpose Sensors due to incorrect calibration that may cause variability in needle path projection.
Product
CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromagnetic sensor for use with 3D Guidance driveBAY, driveBAY 2, trakSTAR, or trakSTAR2 trackers, Ref. 10441627. The firm name on the label is CIVCO, Kalona, IA. The kit contains sensor component part…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1948-2012·2012-07-18
ArjoHuntleigh Recalls Chorus Mobile Patient Lifters Due to Injury Risk
ArjoHuntleigh is recalling specific Chorus Mobile Patient Lifters because an exposed metal support bracket can cause injuries when the knee pad assembly is removed.
Product
Chorus Mobile Patient Lifter; manufactured by Arjo Ltd., St. Catherine Street, Gloucester, GL1 2SL, England, U.K.; Models KKB5060-21US, KKB5062-21US and KKB5080-21US. The Chorus is designed to be used as a standing and raising aid, it is useful for short transfers from one…
Category
Medical Device
Distribution
Distributed nationwide

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40251–40275 of 40480