Browse Device Recalls

2,437 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,437 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,437 FDA device recalls in 2013.

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DateProductReasonClassFirm
Aug 20, 2013 FSE Image Upgrade Kit, Catalog # 92019C This kit is used to install and/or... The FSE Image Upgrade kit (part 92019C) is recalled due to issue related to the export of data fr... Class III Bio-Rad Laboratories
Aug 20, 2013 iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerat... The development partner of IBA informed that there is problem in a SW component used in COMPASS w... Class II Iba Dosimetry Gmbh
Aug 20, 2013 Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Sta... Carestream received a report of an exposure being initiated without a patient image captured. The... Class II Carestream Health Inc.
Aug 19, 2013 The FL23SE Bed is an AC-powered adjustable hospital bed with four built-in el... The nurse call cable (Part Number: QDF23-0571) on the FL23SE Bed is located right under the openi... Class II Stryker Medical Division of Stryker Corporation
Aug 19, 2013 TEGRIS system Four labels of the Tegris System include: Emergency butt... MAQUET has identified a potential issue that might occur because of the lack of an emergency stop... Class II Maquet Cardiovascular Us Sales, Llc
Aug 19, 2013 Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. ... Lumenis has initiated a recall on certain models of Vision One System due to a potential for unin... Class II Lumenis, Inc.
Aug 19, 2013 ACCU-CHECK FastClix Lancing Device. It is intended for use in conjunction wit... Internal Roche inspections have revealed that after the lancet is used for a finger stick, the ne... Class II Roche Diagnostics Operations, Inc.
Aug 16, 2013 Symbia T Series SPECT + CT Product Usage 1) SPECT: To Detect or image the... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 5 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 3 mL Fill Pr... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100I... GE Healthcare has become aware of a potential safety issue involving missing screws in the overhe... Class II GE Healthcare, LLC
Aug 16, 2013 ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 ... PTH Calibrator packaged with only high calibrator. Class III Siemens Healthcare Diagnostics, Inc
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 10 mL Fill Prod... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 POWERWAND Safety Introducer with Extended Dwell Catheter; Catalog no. 92006.... Access Scientific is recalling the POWERWAND Saftey Introducer with Extended Dwell Catheter becau... Class II Access Scientific Inc
Aug 16, 2013 Symbia S, Product Usage 1) SPECT: To Detect or image the distribution of r... The detectors on the Symbia S and Symbia T camera systems are supported and moved horizontally an... Class II Siemens Medical Solutions USA, Inc.
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 100 Units/mL Heparin Lock Flush, 12 mL Syringe with 5 mL Fill Produ... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill P... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 16, 2013 Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune... Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1 and Neptune 2 Was... Class II Zeppessis Reprocessing, LLC
Aug 16, 2013 Monoject 10 Units/mL Heparin Lock Flush, 12 mL Syringe with 3 mL Fill Produc... Monoject prefill flush syringes may contain non-sterile water and labeled as saline or heparin Class II Covidien LLC
Aug 15, 2013 DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Clinical mistreatment may occur when there are errors in the clinical workflow, or settings are i... Class II Elekta, Inc.
Aug 15, 2013 Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Me... Dr¿ger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained... Class II Steris Corporation
Aug 15, 2013 QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000... The manufacturer has conducted a review of the results of product testing performed during the la... Class II Maquet Cardiovascular Us Sales, Llc
Aug 14, 2013 ANGIO PACK #2; REF: DYNJ39185; Packaged in Mexico by: Medline Industries, Inc... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH LAB CUSTOM PACK; REF: DYNJ40926; Packaged in Mexico by: Medline Industri... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 ANGIOGRAPHY PACK; REF: DYNJ26855D; Packaged in Mexico by: Medline Industries,... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH ANGIOGRAPHY DRAPE PACK; REF: DYNJ40851; Packaged in Mexico for Medline I... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE CATH LAB PACK; REF: SAMP0213; Packaged for Medline Industries,... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH PACK; REF: DYNJ41103; Packaged in Mexico by: Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE BUILD; REF: SAMP0147; Packaged for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 STERILE SAMPLE BUILD; REF: SAMP0144; Packaged for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 CATH PACK; REF: DYNJ40904; Packaged in Mexico for Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 Draeger Fabius GS Premium, Fabius OS, Fabius Tiro, Fabius Tiro D-M Product... During final testing of the Draeger Fabius GS Premium, Fabius OS, and Fabius Tiro anesthesia mach... Class I Draeger Medical, Inc.
Aug 14, 2013 CATH TRAY; REF: DYNJ41101; Packaged in Mexico by: Medline Industries, Inc., M... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 14, 2013 HEART CATH CUSTOM PACK; REF: DYNJ39747A; Packaged in Mexico by: Medline Indus... Guidewire .035x150 3MMJ TCFC, item number 88241, has a potential for the coating to flake off of ... Class I Medline Industries, Inc.
Aug 13, 2013 Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) ... May not perform as intended under certain conditions, causing the release of results to the Labor... Class II Siemens Healthcare Diagnostics, Inc.
Aug 13, 2013 MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Me... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 Cypher MIS Screw System, Biomet Spine Parsippany, NJ 07054. The Cypher MIS Sc... Several complaints were reported to exhibit screw head splay in the Cypher MIS Screw System. Class II Ebi, Llc
Aug 13, 2013 MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstrea... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 AEQUALIS Reversed II or AEQUALIS Reversed Fracture Impactor. These products ... Following the identification of the disassociation of an impactor tip during surgery, Tornier is ... Class II Tornier, Inc
Aug 13, 2013 MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream progra... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.
Aug 13, 2013 Synthes Application Instrument Sternal Zip Flex System intended for use in... When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant wh... Class II Synthes USA HQ, Inc.
Aug 13, 2013 GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 ... GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on... Class II GE Healthcare, LLC
Aug 13, 2013 MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programma... Drug flow rates exceeding programmed flow rates. Class I Codman & Shurtleff, Inc.

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.