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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Date	Product	Reason	Class	Firm
Aug 28, 2013	* 1) SYMBIQ One-Channel Infuser; * 2) SYMBIQ Two-Channel Infuser; **...	Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10) instead of the corr...	Class II	Hospira Inc.
Aug 28, 2013	GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Inte...	GE Healthcare has recently become aware of a potential safety issue involving unresponsive button...	Class I	GE Healthcare, LLC
Aug 28, 2013	C2244.3808, CONELOG Titanium Base CC ¿3.8GH0.8 inkl HS Product Usage: End...	Product not cleared for sale/use in the United States.	Class II	Camlog Usa
Aug 28, 2013	C2244.3820;, CONELOG Titanium Base CC ¿3.8GH2.0 inkl HS Product Usage: En...	Product not cleared for sale/use in the United States.	Class II	Camlog Usa
Aug 28, 2013	*** 1) Cat. 4341B; Qty. 10; Thoracentesis Tray; With Catheter; Sterile; CareF...	Catheters included in Thoracentesis Tray and Safe-T Thoracentesis Tray - Drug Free may occlude, p...	Class II	Carefusion 2200 Inc
Aug 28, 2013	VerSys¿ Cemented Revision Calcar (CRC) Hip System Femoral Stems VerSys Herit...	Based on a review of historic packaging validations, it was determined that a subset of product p...	Class II	Zimmer, Inc.
Aug 28, 2013	Siemens RAD Fluoro Uro System (Ysio, Luminos dRF, and Uroskop Omnia) with sof...	When using systems operating with software versions VD10A/G during a RAD examination, a malfuncti...	Class II	Siemens Medical Solutions USA, Inc
Aug 28, 2013	Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse ...	The sterility of this product to a Sterility Assurance Level (SAL) of 10(-6) cannot be assured.	Class II	Globus Medical, Inc.
Aug 28, 2013	S-LIFT Extension Shims Extension shims are manufactured from grade 5 titaniu...	Fit variation among all lots of S-LIFT extension shims with corresponding retractor blades. The f...	Class II	SpineFrontier, Inc.
Aug 28, 2013	C2244.5008 CONELOG Titanbasis CAD/CAM Conelog Titanium Base CAD/CAM Rx onl...	Product not cleared for sale/use in the United States.	Class II	Camlog Usa
Aug 28, 2013	C2244.4308 CONELOG Titanium Base CC ¿4.3GH2 0.8 inkl HS Product Usage: En...	Product not cleared for sale/use in the United States.	Class II	Camlog Usa
Aug 28, 2013	Ti-Magna Fx Washer Ti-Versa-FX¿II Femoral Fixation System S/C Plates Th...	Zimmer recently conducted a review of historic packaging validations completed. Based on this re...	Class II	Zimmer, Inc.
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573...	Medical device tubing used for endotracheal airway application may become weakened and rendered i...	Class I	H & H Associates
Aug 27, 2013	T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material N...	Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ...	Class II	Siemens Healthcare Diagnostics
Aug 27, 2013	Captia Syphilis-G Test Kit Product Usage: This is an enzyme immunoassay f...	Trinity Biotech recalled Trinity Biotech Captia Syphilis IgG kits due to false negative results.	Class II	Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 1...	Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number ...	Class II	Siemens Healthcare Diagnostics
Aug 27, 2013	GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 27, 2013	GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1...	The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert...	Class II	Smith & Nephew Inc
Aug 26, 2013	Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating...	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi...	Class II	Edwards Lifesciences, LLC
Aug 26, 2013	Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/0884261...	Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of li...	Class II	Bayer Healthcare Llc
Aug 26, 2013	Merge Mammo is a multi-modality, vendor-neutral digital mammography workstati...	There is a potential safety issue with the 8.0.2 version software of the Merge (Cedara) Mammo vie...	Class II	GE Healthcare It
Aug 26, 2013	Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, ...	Possibility of the weld to the quick-connect breaking when force is applied to the handle for pe...	Class II	Zimmer, Inc.
Aug 26, 2013	Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ...	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi...	Class II	Edwards Lifesciences, LLC
Aug 26, 2013	Crocodile (size 3) are two-armed, wheeled walking aids, used by children with...	The bolts, which secure the handles, on the Crocodile (size 3) could break, causing the handle to...	Class II	Snug Seat Inc
Aug 26, 2013	Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL...	Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received.	Class II	Biomet 3i, LLC
Aug 23, 2013	BD Epilor Syringe BD Franklin Lakes, NJ 07417 BD EDC Laagstraat 57, B-914...	BD has received several reports indicating that the plunger of the 7 mL BD Epilor plastic BD Luer...	Class II	Becton Dickinson & Company
Aug 23, 2013	Universal Titanium Prosthesis, Round Head, with Flex H/A titanium shoe. The e...	One lot of the product was assembled using the Cam Head version of the same prosthesis instead of...	Class II	Medtronic Xomed, Inc.
Aug 22, 2013	Spectre Wireless Footswitch/Handswitch system Model 98/99, Model FDS, Model F...	TransAmerican Medical Imaging is recalling certain lots of TMI Spectre Wireless Footswitch/Hand s...	Class II	Trans American Medical, Inc.
Aug 22, 2013	Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, M...	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin...	Class II	Biomet Spine, LLC
Aug 22, 2013	Baxa Vial Adapter, 14mm - Luer Lock, Order No. REF: 90, Quantity: 50 each, Si...	Baxter Healthcare Corporation is voluntarily recalling one lot of Baxa Vial Adapters, 14mm - Luer...	Class II	Baxa Corporation
Aug 22, 2013	Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 86...	The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when i...	Class II	Biomet Spine, LLC
Aug 22, 2013	Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Ti...	The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when insertin...	Class II	Biomet Spine, LLC
Aug 22, 2013	Surgicutt fully automated incision making device for bleeding time determinat...	ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L...	Class II	ITC-Nexus Dx
Aug 22, 2013	BIOMET Spine, 5.5 TI 5.5x50mm Translation Screw Polaris 5.5 TI Spinal System...	Polaris Translation Screw Failures were recently reported to Biomet Spine. These failures are ge...	Class II	Ebi, Llc
Aug 21, 2013	Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: Mi...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan plus Negative Combo 3 Sold outside of US only. Product Usage:...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: Mi...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cut...	No antibacterial bandages were packed in boxes labeled as antibacterial.	Class II	ASO, LLC
Aug 21, 2013	Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Syne...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan plus Negative Urine Combo 4 Sold outside of US only. Product ...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Pro...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: Mic...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: Micro...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan¿...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, Inc.
Aug 21, 2013	Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroSca...	Confirmed increase in false susceptible and false intermediate misreads for Imipenem and/or merop...	Class I	Siemens Healthcare Diagnostics, 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.