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

37301–37325 of 40449

ModerateFDA (Devices)·Z-0161-2014·2013-11-13
Smiths Medical Recalls Portex Spinal Trays with Particulate Contamination
Smiths Medical is recalling Portex Spinal Trays because visual particulate was found in the lidocaine and dextrose ampules.
Product
Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0176-2014·2013-11-13
Pinook Mini Massager Recalled for Failure to Submit Premarket Approval
Pinook-Usa is recalling 28,994 Pinook Mini Massagers because the company failed to submit a premarket submission and gain approval for the medical device.
Product
Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0131-2014·2013-11-13
Smith & Nephew Recalls Swapped Genesis II Tibial Base Implants
Smith & Nephew is recalling four units of Genesis II tibial base implants due to packaging errors where size 5 left and size 6 right components were swapped.
Product
GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0133-2014·2013-11-13
EKOS EkoSonic Control Unit Recalled for Missing AC Filter
EKOS Corporation is recalling EkoSonic Control Units because they have the incorrect power entry module installed and are missing an AC filter.
Product
The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The…
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0178-2014·2013-11-13
SEPPIM Recalls Calcium Arsenazo Reagent Due to Inaccurate Plasma Results
SEPPIM SAS is recalling Calcium Arsenazo reagent kits because plasma specimens may report higher calcium results than serum.
Product
Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the…
Category
Medical Device
Distribution
2 states
ModerateFDA (Devices)·Z-0144-2014·2013-11-13
Insight Instruments Recalls MLS Torpedo Mini-Light Ophthalmic Illuminator
Insight Instruments is recalling MLS Torpedo Mini-Light Ophthalmic illuminators because the product was registered as a Class I device but is actually a Class II device requiring FDA clearance.
Product
MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired.
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0128-2014·2013-11-13
Helix Medical Recalls Blom-Singer Adjustable Tracheostoma Valve II Due to Missing Component
Helix Medical LLC is recalling 47 units of the Blom-Singer Adjustable Tracheostoma Valve II because the essential body component is missing from the packaging, rendering the device unusable.
Product
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0174-2014·2013-11-13
St. Jude Medical Recalls Ablation Catheters Due to Incorrect Instructions
St. Jude Medical is recalling 59 ablation catheters shipped with the wrong Instructions for Use (IFU). The recall covers specific batches distributed in six US states.
Product
US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a…
Category
Medical Device
Distribution
6 states
LowFDA (Devices)·Z-0146-2014·2013-11-13
Intuitive Surgical Recalls da Vinci Vision System Cart Components
Intuitive Surgical is recalling da Vinci Vision System Cart components due to a coating incompatibility that triggers erroneous maintenance alerts.
Product
da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD…
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-0173-2014·2013-11-13
Siemens ADVIA Centaur Intact PTH Calibrator Recalled for Packaging Error
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Intact PTH Calibrators because some kits were packaged with only the high calibrator.
Product
ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0084-2014·2013-11-06
Pentax Medical Recalls OF-B194 Gas/Water Feeding Valves for Endoscopes
Pentax Medical is recalling 76 OF-B194 Gas/Water Feeding Valves due to a manufacturing defect that may cause improper CO2 gas stoppage during endoscopic procedures.
Product
PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0114-2014·2013-11-06
Synthes Sternal Zip Flex System Recalled for Implant Cutting Risk
Synthes USA HQ, Inc. is recalling 319 units of the Sternal Zip Flex System because the application instrument may cut the implant, leading to loosening.
Product
Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0042-2014·2013-11-06
Atossa ForeCYTE Breast Health Test Recalled for Labeling and Marketing Concerns
Atossa Genetics is recalling ForeCYTE Breast Health Test kits due to FDA concerns regarding instructions for use and promotional claims.
Product
Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-0091-2014·2013-11-06
Edwards Lifesciences Recalls EMBOL-X Glide Protection System Due to Deformation
Edwards Lifesciences is recalling EMBOL-X Glide Protection Systems because the cannula tip may deform. The recall covers 12,034 units distributed in the US and Canada.
Product
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0125-2014·2013-11-06
Medtronic Activa Deep Brain Stimulators Recalled for Potential Overstimulation
Medtronic is recalling Activa PC and RC deep brain stimulators due to a potential for overstimulation or stimulation in the wrong area during device recovery.
Product
Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0107-2014·2013-11-06
Siemens RAPIDLab Blood Gas Analyzer Recall for Patient ID Error Risk
Siemens is recalling RAPIDLab and RAPIDPoint blood gas analyzers because users can enter wrong patient IDs, risking sample misidentification.
Product
Siemens RAPIDLab¿ 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0123-2014·2013-11-06
Globus Medical Recalls MicroFuse Putty Due to Sterility Assurance Concerns
Globus Medical is recalling MicroFuse Putty because the sterility assurance level cannot be verified. The product is a bone graft extender used in medical procedures.
Product
Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0120-2014·2013-11-06
Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating
Toshiba is recalling 477 Xario XG Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Product
Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0118-2014·2013-11-06
GE Centricity PACS-IW Software Recall for Patient Safety Risks
GE Healthcare is recalling Centricity PACS-IW software due to issues that could display incorrect patient images or under-report dose values, posing a safety risk to patients.
Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-0039-2014·2013-11-06
Xoran Minicat CT Scanners Recalled for Dose Rate Failures
Xoran Technologies is recalling Minicat CT Scanners that failed to meet specifications for dose rate, potentially affecting patient safety.
Product
Xoran Minicat00158
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0102-2014·2013-11-06
Siemens RAPIDPoint 400 Blood Gas Analyzer Recalled for Sample Misidentification Risk
Siemens Healthcare Diagnostics Inc. is recalling RAPIDPoint 400 series blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Product
Siemens RAPIDPoint¿ 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples.…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0041-2014·2013-11-06
Xoran MiniCAT CT Scanner Recalled for Gantry Rotation Failure
Xoran Technologies is recalling 320 MiniCAT CT Scanners because the gantry may fail to rotate while emitting radiation.
Product
Xoran MiniCAT CT Scanner ID ENT00001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0095-2014·2013-11-06
DePuy Spine Recalls Pipeline LS Dilators for Uncleared Neuromonitoring Use
DePuy Spine is recalling 102 units of Pipeline LS Dilators and Holding Clips because they were used for neuromonitoring, a function for which the devices are not FDA cleared.
Product
PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0103-2014·2013-11-06
Siemens RAPIDPoint 405 Blood Gas Analyzer Recalled for Sample Misidentification Risk
Siemens is recalling RAPIDPoint 405 blood gas analyzers because users may enter incorrect patient IDs, leading to sample misidentification.
Product
Siemens RAPIDPoint¿¿ 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0121-2014·2013-11-06
Toshiba Diagnostic Ultrasound Systems Recalled for Transducer Overheating
Toshiba is recalling 427 Aplio MX Diagnostic Ultrasound Systems because the transducer head may overheat during specific imaging modes.
Product
Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging
Category
Medical Device
Distribution
Distributed nationwide

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37301–37325 of 40449