Browse Device Recalls

65 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 65 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 65 FDA device recalls in 2010.

Date	Product	Reason	Class	Firm
Dec 31, 2010	ULTRA Fabric Reinforced Surgical Gown, X-Large, Sterile, Test File. The Ki...	The impacted product was not intended for commercial distribution to end users.	Class III	Kimberly-Clark Corporation
Dec 17, 2010	M3150 Information Center Local Database; Models: 862249, 865001, 865003, 8650...	Potential for early component failure.	Class II	Philips Electronics North America Corporation
Dec 9, 2010	TI Standard Polyaxial Screw Assembly 6.5MM x 55MM. Part # 62065-55. Subse...	The recall was initiated because Alphatec Spine confirmed that the TI Standard Polyaxial Screw As...	Class II	Alphatec Spine, Inc.
Dec 1, 2010	BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usag...	Firm has confirmed that if the Cleaner SCS vial becomes empty after processing a test for Antithr...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 26, 2010	Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat.	The main harness connector was manufactured without the required back shield sealing protection. ...	Class II	Pride Mobility Products Corp
Nov 22, 2010	The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level ...	Incorrect control range in product labeling	Class III	Medtest Holdings, Inc.
Nov 1, 2010	Terumo CDI 101 Hematocrit/Oxygen Saturation Monitoring System. Monitors blood...	Inaccurate readings. Software contains unused (turned off) accuracy correction factors for slope...	Class II	Terumo Cardiovascular Systems Corporation
Nov 1, 2010	Canon Solid State X-ray Imager (Flat Panel/Digital Imager), Digital Radiograp...	Screws holding the 55REF circuit board are loosening and roaming inside of the sealed sensor.	Class II	Canon Inc.
Oct 12, 2010	Medtronic 0-arm Imaging System with Software Version 3.1.1, Catalog Numbers: ...	Software Version 3.1.1 does not meet navigational accuracy.	Class II	Medtronic Navigation, Inc.
Oct 10, 2010	. 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys F...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	Product 100789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 Ver...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00789503201 VerSys Femoral Head Provisional 32mm -3.5 00789503202 VerSys Fem...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	. 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys F...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 10, 2010	00789504001 VerSys Femoral Head Provisional 40mm -3.5 00789504002 VerSys Fem...	Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been en...	Class II	Zimmer, Inc.
Oct 5, 2010	Sunquest Laboratory LabAccess Results Workstation (LARS)	The recall was initiated because Sunquest has confirmed that the Sunquest Laboratory LabAccess Re...	Class II	Sunquest Information Systems, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Sep 27, 2010	Interfaces subject to recall: Medtronic NIM (Nerve Integrity Monitor) 3.0 ...	In January 2010, Medtronic issued a recall of Medtronic NIM 3.0 Patient Interfaces after Medtroni...	Class II	Medtronic Xomed, Inc.
Sep 22, 2010	ISE Electrolyte Reference reagent (for Synchron LX Systems and UniCel DxC 600...	Beckman Coulter is recalling the Synchron Systems LX20/UniCel DxC ISE Reference Reagent because i...	Class II	Beckman Coulter Inc.
Sep 16, 2010	Kimberly-Clark Patient Warming System - Model 1000 Control Unit The produc...	Error 85 alarm on the Model 1000 Control Unit was occasionally triggered inappropriately.	Class II	Kimberly-Clark Corporation
Aug 18, 2010	G7 HPLC. Used as an aid in the detection and presumptive identification of...	The Beta-thalessemia Mode of the G7 Analyzer-Beta Thalassemia Mode is an automated High Performan...	Class III	Tosoh Bioscience Inc
Aug 11, 2010	Polar Dressing, Knee/MU/Shldr Intelli-Flo-Breg, PN 10630 Used with cold th...	This recall has been initiated due to confirmation that the Polar Dressing, Knee/MU/Shldr Intelli...	Class II	Breg Inc, An Orthofix Company
Aug 11, 2010	DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. ...	There is an issue with the DPM 6 and DPM 7 monitors where the following features may be unavailab...	Class II	Mindray DS USA, Inc. d.b.a. Mindray North America
Aug 4, 2010	Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as ...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr...	Class III	Clinical Diagnostic Solutions
Aug 4, 2010	Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a cont...	Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Pr...	Class III	Clinical Diagnostic Solutions
Jul 29, 2010	TD-Synergy. Laboratory Information System.	Technidata has discovered that using the F8 key in the ERM session to add a combined test can res...	Class II	Technidata S.A.
Jul 27, 2010	Xoran Mini CT Scanner	A description of the defect in the product or the manner in which the product fails to comply wit...	Class II	Xoran Technologies, Inc.
Jul 27, 2010	Xoran Minicat00202	The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do...	Class II	Xoran Technologies, Inc.
Jul 27, 2010	Xoran MiniCAT00202	The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do...	Class II	Xoran Technologies, Inc.
Jul 27, 2010	Xoran MiniCAT CT Scanner	A description of the defect in the product or the manner in which the product fails to comply wvi...	Class II	Xoran Technologies, Inc.
Jul 27, 2010	Xoran Minicat00158	The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for do...	Class II	Xoran Technologies, Inc.
Jun 22, 2010	Kimberly-Clark MIC PEG Kit - Pull Type The Kimberly-Clark MIC PEG Kits - P...	The placement guidewire diameter is too large and does not pass-through the introducer needle dur...	Class II	Kimberly-Clark Corporation
Jun 22, 2010	Kimberly-Clark MIC Safety PEG Kit - Pull Type The Kimberly-Clark MIC PEG K...	The placement guidewire diameter is too large and does not pass-through the introducer needle dur...	Class II	Kimberly-Clark Corporation
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended 5mm PTFE Coated Ball 5.0 ...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Coated Blade 6.5 (...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Coated Needle with E...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Needle 6.5" (16.51cm...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Coated Blade with Ex...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Standard PTFE Coated Needle with E...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Staight Microsurgical Needle 3cm ...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Standard PTFE Coated Blade with Ex...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Coated Blade with Ex...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, Inc.
Jun 16, 2010	Product is labeled in part: "*MEDLINE*Extended PTFE Coated Needle 4.0" (...	On 6/16/2010 Unimed Surgical Products, Inc., 10401 Belcher Road, Largo, FL 33777 initiated a reca...	Class II	Unimed Surgical Products, 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.