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

36976–37000 of 40325

HighFDA (Devices)·Z-0367-2014·2013-11-27
GE Healthcare Recalls SPECT Imaging Systems Due to Potential Patient Contact Hazard
GE Healthcare is recalling four models of nuclear medicine and CT imaging systems because the detector may contact a patient's elbow during specific SPECT scans.
Product
GE Healthcare Discovery NMCT 670, Discovery NM 630, Optima NMCT 640, & Brivo NM 615. The GE Discovery NMJCT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0371-2014·2013-11-27
FDA Recalls Medcare Max-500 Patient Stands Due to Load Failure Risk
Ergosafe Products LLC is recalling 233 Medcare Max-500 patient stands because the lift mechanism might fail under the labeled 500-lb load rating.
Product
Medcare Products Max-500 Stand-N-Weigh, Total Support, patient stand, model #400007. The responsible firm name listed in the Operations Manual is Medcare Products, Burnsville, MN. Used for assisting patients/residents to a standing position.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0335-2014·2013-11-27
Philips Brilliance iCT CT Scanner Recall for Footrest Contact Hazard
Philips is recalling nine Brilliance iCT CT scanners because the footrest extension can contact the gantry or user during operation.
Product
Brilliance iCT Computed Tomography X-Ray System, Product Usage: The Brilliance iCT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0330-2014·2013-11-27
GE Centricity Laboratory Software Recalled for Panel Reflex Failure
GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.
Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0329-2014·2013-11-27
Olympus Endoscopic Flushing Pump Recalled for Potential Standby Mode Failure
Olympus America Inc. is recalling 263 Endoscopic Flushing Pumps because the pump head may not be locked, potentially causing the device to stop and enter power stand-by mode during procedures.
Product
Olympus Endoscopic Flushing Pump, Model OPF-2. Facilitates washing of tissues to remove blood, feces and other organic matter during endoscopic procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0305-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry CK Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS Chemistry CK Slides due to slide dispense issues. The recall affects 86,503 units distributed worldwide.
Product
VITROS Chemistry Products CK Slides packaged as 300 slides/pack catalog number 8479396 and packaged as 90 slides/pack catalog number 8478034 VITROS CK Slides quantitatively measure creatine kinase (CK) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0344-2014·2013-11-27
Siemens ADVIA Chemistry System Software Recalled for Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 1650 system software due to incorrect ration parameter flagging behavior.
Product
ADVIA 1650 System Software: 1) V4.01, 2) V3.52. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0351-2014·2013-11-27
Spacelabs qube Patient Monitor Recalled for Power-On Failure
Spacelabs Healthcare is recalling 54 qube Compact Patient Monitors because an incorrect microcontroller may prevent the device from powering on.
Product
Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0340-2014·2013-11-27
Stryker Recalls Reprocessed Diagnostic Electrophysiology Catheters and Cables
Stryker Sustainability Solutions is recalling 46 reprocessed diagnostic electrophysiology catheters and cables due to a potential sterility breach in the package seal.
Product
Reprocessed Diagnostic Electrophysiology (EP) Catheters and Diagnostic EP Catheter Cables, Model Numbers: D6-DR-252-RT, F6-QF-252RT, 201101, 201104, 401442, 401860, D7-A20-131-RT, 401661, 401972, 401977, 401981, 401982, C6-MR/MST4-SA, CB3434CT. Product Usage: Reprocessed…
Category
Medical Device
Distribution
4 states
HighFDA (Devices)·Z-0364-2014·2013-11-27
Biomet Recalls Juggerknotless Drill Bits Due to Insertion Difficulty
Biomet, Inc. is recalling 25 units of Juggerknotless Drill Bits because the design may make it difficult to insert the suture anchor into the bone.
Product
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0304-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.
Product
VITROS Chemistry Products CHOL Slides packaged as 300 slides/pack catalog number 1669829 VITROS CHOL Slides quantitatively measure cholesterol (CHOL) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600 Integrated…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0359-2014·2013-11-27
Biomet Spine Recalls Polaris Translation Screws Due to Head Dissociation
Biomet Spine is recalling 7,092 Polaris Translation Screws because the screw head may separate from the shaft. The recall covers nationwide distribution including Puerto Rico.
Product
BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System. Rx Only. Non-Sterile. Intended for immobilization and stabilization as an adjunct to fusion as a pedicle screw fixation system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0361-2014·2013-11-27
Aesculap Arcadius XP L Trial Insertion Instrument Recall for Weak Weld
Aesculap is recalling 30 Arcadius XP L Trial Insertion Instruments because a weak weld may cause the device to disassemble during use.
Product
Aesculap Arcadius XP L Trial Insertion Instrument (ME020R/ME020R-US)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0342-2014·2013-11-27
Trumpf TruSystem Surgical Table Leg Section Recall for Detachment Risk
Trumpf Medical Systems is recalling 15 TruSystem Surgical Table Leg Section One Part Light components because the coupler point may detach from the frame.
Product
TruSystem Surgical Table (TS7000) Leg Section One Part Light HU Use of the Leg Section One Part Light HU is permitted only with the TRUMPF TruSystem 7000 operating table. The operating table TruSystem 7000, in conjunction with operating table components is intended for the…
Category
Medical Device
Distribution
8 states
HighFDA (Devices)·Z-0375-2014·2013-11-27
Stryker Spine Recalls XIA Torque Wrenches Due to Fracturing Hex Tips
Stryker Spine is recalling XIA and Mantis Redux torque wrenches because the hex tips may fracture during final tightening.
Product
Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine SAS Z.I. Marticot -33610 -CESTAS -FRANCE +33 (0) 5.57.97.06.30 http://www.stryker.com Distributed in the USA by: Stryker Spine 2 Pearl Court…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0334-2014·2013-11-27
Zeiss IOLMaster 500 Recalled for Erroneous Lens Database Value
Carl Zeiss Meditec is recalling 1,201 IOLMaster 500 devices because an incorrect database value for the AMO Sensar AR40E lens could lead to the implantation of lenses with the wrong diopter.
Product
Zeiss brand IOLMaster 500, Model 500, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0333-2014·2013-11-27
Zeiss IOLMaster Recalled for Incorrect Lens Database Value
Carl Zeiss Meditec is recalling 4,907 IOLMaster devices because an incorrect lens constant in the internal database could lead to the implantation of intraocular lenses with the wrong power.
Product
Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0328-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 85,646 units distributed worldwide.
Product
VITROS Chemistry Products URIC Slides packaged as 300 slides/pack catalog number 1943927 VITROS URIC Slides quantitatively measure uric acid (URIC) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0300-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Product BuBc Slides due to slide dispense issues.
Product
VITROS Chemistry Products BuBc Slides packaged as 300 slides/pack catalog number 8383051 and packaged as 90 slides/pack catalog number 1612365 VITROS BuBc Slides quantitatively measure unconjugated bilirubin (Bu) and conjugated bilirubin (Bc) concentrations in serum and plasma…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0317-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry LIPA Slides
Ortho-Clinical Diagnostics is recalling VITROS Chemistry LIPA Slides due to slide dispense issues affecting the cartridges used with the product.
Product
VITROS Chemistry Products LIPA Slides packaged as 300 slides/pack catalog number 1668409 and packaged as 90 slides/pack catalog number 8297749 VITROS LIPA Slides quantitatively measure Lipase (LIPA) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0356-2014·2013-11-27
Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue
Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.
Product
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx)…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0299-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Product Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling Slide Dispense cartridges used with VITROS Chemistry Product Slides due to slide dispense issues.
Product
VITROS Chemistry Products AST Slides packaged as 300 slides/pack catalog number 8433815 VITROS AST Slides quantitatively measure aspartate aminotransferase (AST) activity in serum and plasma using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0320-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS Chemistry Slide Dispense Cartridges
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Slide Dispense cartridges due to slide dispense issues. The recall affects 81,382 units distributed worldwide.
Product
VITROS Chemistry Products PHOS Slides packaged as 300 slides/pack catalog number 1513209 VITROS PHOS Slides quantitatively measure phosphorus (PHOS) concentration in serum, plasma, and urine using VITROS 250/350/950/5,1 FS and 4600 Chemistry Systems and the VITROS 5600…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0326-2014·2013-11-27
Ortho-Clinical Diagnostics Recalls VITROS TRIG Slides for Dispense Issues
Ortho-Clinical Diagnostics is recalling VITROS TRIG Slides and Slide Dispense cartridges due to slide dispense issues. The recall affects 127,662 units distributed worldwide.
Product
VITROS Chemistry Products TRIG Slides packaged as 300 slides/pack catalog number 1336544 and packaged as 90 slides/pack catalog number 8329930 VITROS TRIG Slides quantitatively measure triglyceride (TRIG) concentration in serum and plasma using VITROS 250/350/950/5,1 FS and…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0346-2014·2013-11-27
Siemens ADVIA Chemistry System Software Recalled for Flagging Errors
Siemens Healthcare Diagnostics is recalling ADVIA 2400 System Software V4.01 due to incorrect ration parameter flagging behavior.
Product
ADVIA 2400 System Software V4.01. Performs assays for general and specialty chemistries, methods for specific protein measurement, drugs-of-abuse testing and therapeutic drug monitoring.
Category
Medical Device
Distribution
Distributed nationwide

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