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Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

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DateProductReasonClassFirm
Dec 4, 2014 Stryker Orthobiologics Imbibe Bone Marrow Aspiration Needle, Model Numbers: ... There is the potential for a breach in the inner or outer packaging pouches of all lots of the Im... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 4, 2014 ev3 Protege Rx Tapered Carotid Stent System, SECX-10-7-40-135, Sterile EO, R... Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... Class II Ev3, Inc.
Dec 4, 2014 Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joi... The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to... Class II Hansen Medical Inc
Dec 4, 2014 Trilogy¿ Fiber Metal Acetabular Shell Size 54 mm OD The Trilogy Acetabular... Zimmer received a single complaint wherein a Trilogy® Fiber Metal Multi-Hole Acetabular Shell... Class II Zimmer Manufacturing B.V.
Dec 4, 2014 Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Y... Baxter Corporation initiated a recall of two lots of Self-Righting Luer Lock Tip Caps because the... Class II Baxter Corporation Englewood
Dec 4, 2014 Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Ti... The affected lot was supplied by contract manufacturer and are potentially subject to disassociat... Class II Zimmer, Inc.
Dec 4, 2014 ev3, Prot¿g¿ Rx Tapered Carotid Stent System, SEPX-8-6-40-135, Sterile EO, R... Two production lots of the Protege Rx Tapered Carotid Stent Systems (SECX-10-7-40-135, Lot # 9922... Class II Ev3, Inc.
Dec 4, 2014 Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Number... There is the potential for a breach in the inner or outer packaging pouches of all lots of the St... Class II Orthovita, Inc., dBA Stryker Orthobiologics.
Dec 4, 2014 MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-81... Connector mount cracks which may lead to a leak failure during use and necessitate immediate repl... Class I Teleflex, Inc.
Dec 3, 2014 (R)IR remote control JUPITER, Material no.1219656, Serial number: to (incl.) ... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUPITER, Material no. 4544119, Serial number: to (incl.)... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 POWEREASE Instruments Set Screw Breakoff Instrument, REF 2346010, Medtronic S... The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... Class II Medtronic Sofamor Danek USA Inc
Dec 3, 2014 Rotoprone Therapy System. The Rotoprone Therapy System is an advanced pati... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Dec 3, 2014 RotoRest Delta Advanced Therapy System. The RotoRest Delta Advanced Kineti... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Dec 3, 2014 RTH8 Rotor, P/N X01-005847-001. RTH8 used in the StatSpin Express 4 Horizont... Iris International is recalling the RTH8 Rotor used in the StatSpin Express 4 Horizontal Centrifu... Class II Iris Diagnostics
Dec 3, 2014 IR remote control JUPITER / TS7500, Material no.1601927, Serial number: to (i... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Ferno Model 35X PROFlexx Stretchers, one unit per package The wheel castor assemblies may be loosening on the stretchers. Class II Ferno-Washington Inc
Dec 3, 2014 Artis Q, and Artis Q.zen ceiling systems; model numbers: 10848281; 10848354: ... Suboptimal routing of the cable may result in increased wear over time. Without additional measur... Class II Siemens Medical Solutions USA, Inc
Dec 3, 2014 VC150 Vital Signs Monitor (VC150 monitor equipped with Masimo SpO2 technique ... If the SpO2 or RRa value is violating the respective alarm limit at the time of switching to moni... Class II INNOKAS MEDICAL OY
Dec 3, 2014 IIR remote control JUPITER, Material no.4544120, Serial number: to (incl.) 10... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 Cable remote control JUPITER U, Material no.4500119, Serial number: to (incl.... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUC, BUTTON, Material no.1239824, Serial number: to (incl.)... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 WECK Hemoclip¿ Traditional Medium Tantalum Ligating Clips. Weck Ligating C... The manufacturing dates and expiration dates were transposed on the Tyvek label. Class II Teleflex Medical
Dec 3, 2014 Cable remote control JUC, BUTTON, Material no.1239823, Serial number: to (inc... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUX, Material no.1307314, Serial number: to (incl.) 1023383... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 SOMATOM Force; the intended use of computed tomography is to produce cross-se... Artifacts are found in acquired imaging on the SOMATOM Force. Class II Siemens Medical Solutions USA, Inc
Dec 3, 2014 Cable remote control JUX Material, no.1307315, Serial number: to (incl.) 1012... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 GE Healthcare Pediatric Direct-Wired Disposable Defibrillation/Pacing Electro... The firm discovered that during the use of these defibrillation electrodes a possibility for arci... Class I Leonhard Lang Gmbh
Dec 3, 2014 TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Crit... The recalled devices labeling and instructions for use contain unapproved medical claims. Class II Arjo Hospital Equipment AB
Dec 3, 2014 Cable remote control JUPITER / TS7500, Material no.1601926, Serial number: to... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 (R)Cable remote control JUPITER, Material no.1219655, Serial number: to (incl... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 3, 2014 IR remote control JUPITER U, Material no. 4500120, Serial number: to (incl.) ... Complaints have been reported of unintended movement occurring during surgical cases due to the u... Class II Trumpf Medical Systems, Inc.
Dec 2, 2014 VERO Linear Accelerator System, Model Number MHI-TM2000, MHI Identifier M101-... Software Anomaly. The VERO MHI-TM2000 Operator Console may provide Patient Positioning System (Ex... Class II MITSUBISHI HEAVY INDUSTRIES, LTD., HIROSHIMA MA...
Dec 2, 2014 Siemens Linear Accelerator: ARTISTE, ONCOR Avant Garde, ONCOR Impression Plus... Use of any unauthorized third-party components on Siemens LINACs may lead to patient or operator ... Class II Siemens Medical Solutions USA, Inc
Dec 2, 2014 Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identi... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Dec 2, 2014 Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Nam... After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined ... Class II Biomet, Inc.
Dec 2, 2014 NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibi... During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial ... Class II Zimmer Trabecular Metal Technology, Inc.
Dec 1, 2014 EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Kne... Difficulty locking EXp tibial inserts into tibial trays, caused by a manufacturing condition wher... Class II Stelkast Co
Nov 29, 2014 Adult Air-Life single-limb circuit (Model AH202) with AirLife Humidification ... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with Ai... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Infant AirLife single-limb, continuous-flow circuit (Model AH132) containing ... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, Inc.
Nov 29, 2014 Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010 LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concent... Class I Magellan Diagnostics, Inc.
Nov 29, 2014 Adult AirLife dual-limb, dual-heat circuit (Model AH280) with AirLife Humidif... Manufacturing error in humidification chamber may cause an overfill/overflow condition of the cha... Class I Vyaire Medical
Nov 26, 2014 Carousel MAS1025-01, part of the Brain Surgical Accessories Intra-operative K... In some situations the carousel position pin (locker) may cause the carousel upper plate to pop o... Class II Mazor Robotics Ltd
Nov 26, 2014 VisiPlugST for the Lacrimal Efficiency Test. It is also sold in the EU as Co... Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon conta... Class III Lacrimedics Inc
Nov 26, 2014 SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10,... Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report se... Class II SCC Soft Computer
Nov 26, 2014 Harmony¿ vLED Surgical Lighting System, one unit packaged per box The Harmon... STERIS has learned that groups of LED lights (modules) contained within the vLED light head may i... Class II Steris Corporation
Nov 26, 2014 GETINGE 46-SERIES Medical Washer-Disinfector, Models 46-4 and 46-5, with PACS... Getinge Disinfection AB received complaints regarding sediment residuals in the manifold of the w... Class II Getinge Disinfection Ab
Nov 25, 2014 Zimmer PERSONA Tibial Articular Surface Inserter; Item # 42-5299-001-00. Ma... Potential for fracture of the tip of the product. The fractured tip is approximately 4mm x 7mm x ... Class II Zimmer, 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.