Browse Device Recalls

209 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 209 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 209 FDA device recalls in 2011.

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DateProductReasonClassFirm
Apr 5, 2011 GE LightSpeed CT750 HD The GE LightSpeed CT750 HD Computed Tomography X-ra... GE Healthcare conducted a recall involving 2 events affecting the GE LightSpeed CT750 HD. Event 1... Class II GE Healthcare, LLC
Apr 1, 2011 00789503601 VerSys Femoral Head Provisional 36mm -3.5 00789503602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789503201 VerSys Femoral Head Provisional 32mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302601 MIS 12/14 Slotted Femoral Head Provisional -3.5X26 00780302602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502801 VerSys Femoral Head Provisional 28mm -3.5 00789502802 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 12/14 Neck Taper 00789504001 VerSys Femoral Head Provisional 40mm -3.5 0078... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Fem... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302201 MIS 12/14 Slotted Femoral Head Provisional -2X22 00780302202 MIS... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780302801 MIS 12/14 Slotted Femoral Head Provisional -3.5X28 00780302802 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303201 MIS 12/14 Slotted Femoral Head Provisional -3.5X32 00780303202 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00780303601 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780303602 M... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Apr 1, 2011 00789502202 VerSys Femoral Head Provisional 22mm +0 00789502203 VerSys Femor... Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys... Class II Zimmer, Inc.
Mar 31, 2011 Anspach REF: TURQ-434-4 Twist Drill for 1.5mm x 4mm screw. Rx only Single... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 31, 2011 AnspacSingle use Sterile bone cutting burs.h REF: S-1504TD Twist Drill for 1.... Cutter was longer than was stated on the label Class II The Anspach Effort, Inc.
Mar 25, 2011 GE Healthcare, Model Number/ Description: 5342114 GSI Viewer 1.10 on AW Volu... When performing a secondary capture generated from GSI Viewer, the header information is correct ... Class II GE Healthcare, LLC
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 24, 2011 Boule Con-Diff Hematology Control For in vitro diagnostic use as a control... Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Produc... Class III Clinical Diagnostic Solutions
Mar 21, 2011 Stryker Reliance AL Implant Blocker (Various sizes) The SLIDE Implant Blo... Stryker Spine has received six reports regarding the breakage of one or more prongs at the extrem... Class II Stryker Spine
Mar 16, 2011 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira Inc.
Mar 16, 2011 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... May go to a white screen due to a problem with the SOM2 module. A white screen is a diagnostic sc... Class II Hospira Inc.
Mar 9, 2011 LANX, REF, PCR8XXX-XXX, LOT, RXONLY. Packaged within aluminum sterilization ... Biomet Spine, LLC. announces voluntary recall of Durango Anchored ALIF Plate due to the set screw... Class II Biomet Spine LLC.
Mar 7, 2011 Brilliance iCT, Brilliance 64 and Brilliance Big Bore The Brilliance iCT, ... The DoseRight feature suggest a mAs based on the measured patient size, a reference size and a re... Class II Philips Medical Systems (Cleveland) Inc
Mar 4, 2011 Imagecast PACS is an image management system intended to be used by trained p... In Imagecast PACS versions prior to 3.6.51.01, the estimated magnification factor (0018,1114) was... Class II Ge Healthcare It
Mar 4, 2011 Mini-Infuser Model 300XL Multispeed Infusion Pump, an Rx battery operated syr... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 4, 2011 ***REF S-3D*** 3mm Diamond Ball. Used for cutting and shaping bone. Due to three batches of product may have diamond grit size larger than intended applied to the he... Class II The Anspach Effort, Inc.
Mar 4, 2011 Mini-Infuser Model 150XL Single Speed Infusion Pump, an Rx battery operated s... Should a battery with the minimum contact diameter (.51 inches) be placed on the battery spring (... Class III Baxter Healthcare Corp.
Mar 3, 2011 Brilliance 64 Computed Tomography X-Ray System, Model number 728231, running ... Multiple software defects which could impact the performance or reliability of the system. These... Class II Philips Medical Systems (Cleveland) Inc
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Us... Defect in the luer connector can compromise the seal on the female side of the connector and the ... Class II Terumo Cardiovascular Systems Corp
Mar 1, 2011 Terumo Cardioplegia Delivery Set- Item Number: 16130 Produc... Defect in the luer connector can compromise the seal on the female side of the connector. and the... Class II Terumo Cardiovascular Systems Corp
Mar 1, 2011 Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kit... Defect in the luer connector can compromise the seal on the female side of the connector and the ... Class II Terumo Cardiovascular Systems Corp
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypa... Defect in the luer connector can compromise the seal on the female side of the connector and the ... Class II Terumo Cardiovascular Systems Corp
Mar 1, 2011 Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 ... Defect in the luer connector can compromise the seal on the female side of the connector. and the... Class II Terumo Cardiovascular Systems Corp
Mar 1, 2011 Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog N... Defect in the luer connector can compromise the seal on the female side of the connector. and the... Class II Terumo Cardiovascular Systems Corp
Feb 4, 2011 GE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular... Exposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of ... Class II GE Healthcare, LLC
Feb 2, 2011 AC Powered adjustable hospital bed, Prime Bed TL500, Distributed by: Primus M... The "Retaining washers & Clevis Pins" provided with the AC -powered adjustable hospital beds may ... Class II Primus Medical LLC
Jan 31, 2011 Sleek OTW***REF 426-1201X***Inflated Balloon Dia/mm***1.25***Inflated Balloon... On 1/20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dilat... Class II Cordis Corporation
Jan 31, 2011 Sleek ***OTW ***Ref ***426-1501X***Inflated Balloon Dia/mm 1.5 Inflated Ballo... On 1//20/2011 Cordis Corporation , Miami Lakes, FL initiated a recall of their Sleek OTW PTA Dila... Class II Cordis Corporation
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, w/Cr... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 1 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenit... Nemschoff Chairs, Inc. is recalling various model of the Serenity Treatment Chair because of pot... Class II Nemschoff Chairs, Inc.
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 22 g... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Modified Kit, Pulset, 3 cc, ... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed Inc
Jan 18, 2011 Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, with... Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRI... Class II Westmed 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.