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

20751–20775 of 27682

SevereFDA (Devices)·Z-0105-2017·2016-11-02
Roche Recalls cobas 8000 Sorting System Modules Due to Injury Reports
Roche is recalling 9,014 cobas 8000 Sorting System calculator/data processing modules after four reports of injury caused by a sharp edge on the sample rack tray.
Product
RSD 800 Sorting System calculator/data processing module, for clinical use Product Usage: The cobas 8000 Modular Analyze Series is a fully automated system for Clinical chemistry analysis, intended for the in vitro qualitative and quantitative determination of analytes in…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0102-2017·2016-11-02
Roche Recalls cobas p 501 Post-Analytical Units Due to Sharp Edges
Roche is recalling 9,014 cobas p 501 Post-Analytical Units because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas p 501 Post-Analytical Unit calculator/data processing module, for clinical use Product Usage: The MODULAR PRE-ANALYTICS system is a fully automated system for sample pre-processing, including centrifuging, aliquoting, and barcode labeling, prior to analysis by MODULAR…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0096-2017·2016-11-02
Roche Recalls cobas 6000 Series Analyzers Due to Sharp Edge Injury Risk
Roche is recalling cobas 6000 Series analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas 6000 Series system c6000, Chemistry (Photometric, Discrete), for clinical Use. Modular e601: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store.…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0117-2017·2016-11-02
St Jude Medical Recalls ICD and CRT-D Devices for Battery Short Circuit
St Jude Medical is recalling implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators due to a battery defect that can cause premature depletion.
Product
Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0115-2017·2016-11-02
St Jude Medical Recalls Implantable Cardiac Defibrillators Due to Battery Defect
St Jude Medical is recalling specific implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because a lithium cluster in the battery can cause a short circuit and premature battery depletion.
Product
Fortify VR, Model No. CD1231-40, CD1231-40Q. Fortify ST VR, Model No. CD1241-40, CD1241-40Q. Fortify Assura VR, Model No. CD1257-40, CD1257-40Q, CD1357-40C. Fortify Assura ST VR, Model No. CD1263-40, CD1263-40Q, CD1363-40, CD1363-40Q. Fortify DR, Model No. CD2231-40…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0108-2017·2016-11-02
Roche Recalls cobas p 471 Centrifuge Units Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas p 471 centrifuge units because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas p 471 centrifuge unit calculator/data processing module, for clinical use Product Usage: The cobas p312 pre-analytical system is a computer controlled stand-alone system for sorting and decapping sample tubes. As an option, the system works with an online connection.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0099-2017·2016-11-02
Roche URISYS 2400 Urine Analyzer Recalled for Sharp Edge Injury Risk
Roche is recalling URISYS 2400 Urine Analyzers because a sharp edge on the sample rack tray caused four reported injuries.
Product
URISYS 2400 Urine Analyzer Automated Urinalysis System Product Usage: The RSD 800 is a computer-controlled stand-alone sorting system for sorting barcoded samples. The system has an online connection to the host.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0098-2017·2016-11-02
Roche Modular Pre Analytics EVO/Plus Recall for Sharp Edge Injury Risk
Roche is recalling Modular Pre Analytics EVO/Plus systems because a sharp edge on the sample rack tray caused four reported injuries.
Product
Modular Pre Analytics ( EVO/Plus) Product Usage: The RSD 800A is a computer-controlled stand-online system for decapping, aliquoting and sorting of primary tubes and for producing and sorting bar coded secondary tubes.. The system operates with an online connection to the…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0100-2017·2016-11-02
Roche COBAS INTEGRA 800 Analyzer Recalled Due to Sharp Edge Injury Reports
Roche is recalling COBAS INTEGRA 800 analyzers after four reports of injury caused by the sharp edge of the sample rack tray.
Product
Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0095-2017·2016-11-02
Roche Recalls cobas e411 Immunoassay Analyzers Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas e411 Immunoassay Analyzers because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas e411 Immunoassay Analyzer e411: Immunoassay Analyzer Product Usage: The cobas p501/p701 instrument stores primary and secondary sample tubes. The tubes are stored in a controlled, refrigerated sample store. Automatic retrieval for add-on testing is possible at any…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0094-2017·2016-11-02
Roche Modular Analytics Systems Recalled Due to Sharp Sample Rack Edge
Roche is recalling Modular Analytics Combination Systems because a sharp edge on the sample rack tray caused four reported injuries. The cleaning procedure has been revised to clarify the process.
Product
Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0110-2017·2016-11-02
Roche Recalls cobas 6800/8800 Systems Due to Sharp Edge Injury Risk
Roche is recalling 9,014 cobas 6800/8800 systems because a sharp edge on the sample rack tray caused four reported injuries.
Product
cobas 6800/8800 system Hepatitis Viral B DNA Detection Product Usage: The cobas p512 pre-analytical system is a computer controlled fully automatic system for sorting of open and closed barcoded and centrifuged sample tubes. It includes modules for registration and…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0106-2017·2016-11-02
Roche cobas p 612 Pre-Analytical Instrument Recall for Sharp Edge Injury
Roche is recalling cobas p 612 Pre-Analytical Instruments because the sharp edge of the sample rack tray center guide rail caused four reported injuries.
Product
cobas p 612 Pre-Analytical Instrument calculator/data processing module, for clinical use Product Usage: The cobas 6000 series is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and quantitative…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0104-2017·2016-11-02
Roche RSD 800A Aliquoting System Recalled Due to Sharp Edge Injury Reports
Roche is recalling 9,014 RSD 800A Aliquoting System calculator/data processing modules because four reports of injury were received from the sharp edge of the sample rack tray.
Product
RSD 800A Aliquoting System calculator/data processing module, for clinical use Product Usage: The Roche/Hitachi MODULAR Analytics System is a fully automated, random-access, software-controlled system for immunoassay and photometric analysis intended for qualitative and…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0316-2017·2016-11-02
Aesculap Safil Suture Recall Due to Needle Detachment Risk
Aesculap is recalling 180 units of Safil QUI + UNDY 5/0 sutures because the needle may detach from the thread during surgery.
Product
Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0314-2017·2016-11-02
BBI Solutions Recalls SimpliRED D-Dimer Assay Kits Due to Performance Issues
BBI Solutions is recalling SimpliRED D-Dimer assay kits because stability testing showed reduced sensitivity, which may cause false negative results and affect clinical decisions.
Product
SimpliRED D-Dimer, Product Code DSRK4 The SimpliRED D-dimer assay is a rapid, qualitative test for the detection of cross-linked fibrin degradation products containing the cross-linked D-diner site in human whole blood
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-0304-2017·2016-11-02
Nova Medical Recalls Journey Rolling Walkers Due to Loose Screws
Nova Medical is recalling 1,380 Journey Rolling Walkers because screws holding the side supports can loosen and fall out.
Product
4205 Journey Rolling Walker Product Usage: used to assist people in walking
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2017·2016-11-02
Hospira Symbiq Infuser Recall for Potential White Screen Error
Hospira is recalling Symbiq One Channel Infusers because a white screen during KVO titration may allow premature programming, potentially causing therapy delays and significant injury.
Product
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0114-2017·2016-11-02
Sequent Medical Recalls VIA 27 Microcatheter Due to Re-sheathing Defect
Sequent Medical is recalling 618 units of the VIA 27 Microcatheter because the device may not adequately re-sheath interventional devices as designed.
Product
VIA 27 Microcatheter, Part No. FG27-154-01, Model No. VIA-27-154-01 The VIA 27 is intended for the introduction of non-liquid interventional devices (such as stents/flow diverters) and infusion of diagnostic (such as contrast media) or therapeutic agents into the neuro…
Category
Medical Device
Distribution
11 states
HighFDA (Devices)·Z-0103-2017·2016-11-02
Roche VS II Aliquoter System recalled due to sharp edge injury risk
Roche is recalling VS II Aliquoter System calculator modules because a sharp edge on the sample rack tray caused four reported injuries.
Product
VS II Aliquoter System calculator/data processing module, for clinical use Product Usage: Elecysy 411 analyzer is a fully automated, random access, computer controlled analytical systems for quantitative and qualitative determinations of analytes in body fluids.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0315-2017·2016-11-02
Intuitive Surgical Recalls da Vinci Xi Systems Due to Software Anomaly
Intuitive Surgical is recalling 677 da Vinci Xi Surgical Systems due to a software anomaly that may cause unexpected movement.
Product
da Vinci¿ Xi" Surgical System, model number IS4000, A70_P5x with P5 Software; General and Plastic Surgery: The Intuitive Surgical Endoscope Instrument Control System (da Vinci Surgical System, Model IS4000) is intended to assist in the accurate control of Intuitive Surgical…
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-0303-2017·2016-11-02
Handicare ReTurn 7500 Transfer Aids Recalled for Ladder Fatigue Risk
Handicare USA is recalling ReTurn 7500 transfer aids because a wing handle defect may cause mechanical fatigue in the ladder.
Product
ReTurn 7500/7500 Aid, transfer
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0306-2017·2016-11-02
Hospira Symbiq Infuser Recall for Potential White Screen Error
Hospira is recalling Symbiq Two Channel Infusers because a white screen error during KVO titration could delay therapy and cause significant injury.
Product
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0301-2017·2016-11-02
Lumenis Recalls FemTouch Delivery System Due to Ineffective Cleaning Instructions
Lumenis Limited is recalling 69 units of the FemTouch delivery system because the provided cleaning instructions may be ineffective for fully assembled devices, posing a risk of cross-contamination.
Product
FemTouch delivery system includes the FemTouch Kit (AC-1007415) and FemTouch" Tip (SPSA-20002590) Provide fractional treatments in gynecology.
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0297-2017·2016-11-02
AccessClosure Recalls PAXWIRE Occlusion Balloon System Due to Removal Risk
AccessClosure, Inc. is voluntarily recalling the PAXWIRE Occlusion Balloon System because the device may be removed without a vascular sheath in place.
Product
The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during…
Category
Medical Device
Distribution
2 states

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20751–20775 of 27682