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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.

Clear
DateProductReasonClassFirm
Jul 15, 2013 HemoCue¿ Glucose 201 Microcuvettes, 25 Microcuvettes Individually Packaged. ... During a complaint investigation HemoCue AB discovered punctured HemoCue Glucose 201 single pack ... Class II HemoCue AB
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 StealthStation S7 Framelink Software version 5.4. Aid for locating anatom... Medtronic Navigation, Inc. has initiated a field correction to their Framelink software version 5... Class II Medtronic Navigation, Inc.
Jul 15, 2013 DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparo... DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompati... Class II DeRoyal Industries Inc
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials) Catalog Number: 43435 ... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Vials) Catalog Number: 43604 These s... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm T... Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class II Endoplus, Inc.
Jul 15, 2013 Nova Max Plus Monitor System (Kit w/10 Count Vials International) Catalog Nu... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877 Produc... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (50 Count International Catalog Number: 45512 ... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955 ... Reports of false abnormally high glucose readings from test strips Class I Nova Biomedical Corporation
Jul 15, 2013 ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm At... Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures. Class II Endoplus, Inc.
Jul 12, 2013 IsoGel AIR 84, Support Surface. Intended to assist in improving human pati... Complaints were received from the field indicating that some Air Pumps were flashing and alarming... Class II Stryker Medical Division of Stryker Corporation
Jul 12, 2013 Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruc... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction,... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. ... Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws ... Class II Ormco/Sybronendo
Jul 12, 2013 OLA Buffer For Laboratory Use; Contents: 1 tube with buffered solution cont... The package insert for FG OLA Buffer, GPR displayed the wrong concentration of ¿M instead of the ... Class III Celera Corporation
Jul 12, 2013 5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical S... No endotoxin (LAL) testing to proper level. Class II Custom Medical Specialties, Inc.
Jul 12, 2013 Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reco... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene IFG with Assisted Delivery Intended for use in arterial vascular re... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstr... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruct... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 11, 2013 AperFix AM Femoral Implant, Model numbers CM-2409 (9mm x 24 mm) and CM-2410 (... Potential for AperFix 24 mm implant breaking inside the drilled femoral socket. Class II Cayenne Medical Inc.
Jul 11, 2013 LPS Lower Extremity Dovetail Intercalary component. Intended for use in re... The LPS Lower Extremity Dovetail Intercalary component has the potential for fracture of the fema... Class I DePuy Orthopaedics, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, ... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 1.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Rultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland,... The firm became aware of the problem when a ratchet cover plate on a device was returned for repa... Class II Pemco Inc
Jul 10, 2013 BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length R... The Lancet will not retract after activation thus creating a potential for exposure to a used sharp. Class II Becton Dickinson & Company
Jul 10, 2013 Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe, 0.... Visible orange/ brown particulate on the needles of the 29g Hypodermic Needle-Pro¿ Fixed Needle I... Class II Smiths Medical ASD, Inc.
Jul 10, 2013 Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-ster... PDC Healthcare initiated this recall of Non-Sterile Viscot Part Number 1437-100 Surgical Skin Mar... Class II Precision Dynamics Corporation
Jul 10, 2013 Acuson SC2000 volume imaging ultrasound systems at software version 3.0. M... Software issue results in inaccurate 3D image may result in ablation in wrong location. Class II Siemens Medical Solutions USA, Inc.
Jul 10, 2013 Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A... TempaDot products may have been mislabeled. Class II Medical Indicators, Inc.
Jul 9, 2013 Tray Surgical, ENT (various instrument trays) Used for stot age and transp... The firm will recall and replace the identified instrument trays in the field, with trays that ha... Class II Medtronic Xomed, Inc.
Jul 8, 2013 Baxter, MiniCap with Povidone-Iodine solution, 5C4466P. For dialysis. the white printed paper layer on the pouch packaging may not be fully adhered to the pouch foil ... Class II Baxter Healthcare Corp.
Jul 8, 2013 Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/... Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to pre... Class II Sorin Group USA, Inc.
Jul 8, 2013 Radiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.... IntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several m... Class II Philips Healthcare Inc.
Jul 8, 2013 Stryker 1) Asnis III Cannulated Screw REF 604640 4.0x40mm TL 13.5mm 2) ... Stryker received a report that the length of the cannulated screw asnis III, article # 604640 Lot... Class II Stryker Howmedica Osteonics Corp.
Jul 8, 2013 GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM... The products were produced using the wrong color material, resulting in the devices being red (u... Class II Smith & Nephew Inc
Jul 8, 2013 PrepStain AG. For use in the screening and detection of cervical cancer. PrepStain system rack setting was incorrectly entered on one PrepStain system during a routine pr... Class II Becton Dickinson & Co.
Jul 8, 2013 Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the intr... Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter ... Class II Medtronic Inc. Cardiac Rhythm Disease Management

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.