Browse Device Recalls
3,313 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,313 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 3,313 FDA device recalls in 2017.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 11, 2017 | OVATIO Models: VR 6250, DR 6550, CRT 6750. Product Usage: OVATIO VR 625... | Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable. | Class II | Sorin Group Italia SRL - CRF |
| Apr 10, 2017 | CooperSurgical lnflatoball Latex Rubber Pessary sold as an individual unit an... | The current secondary packaging, a box, incorrectly states that the product is latex free. The pr... | Class II | CooperSurgical, Inc. |
| Apr 10, 2017 | Proton therapy system -Proteus 235 aka Proteus Plus. A medical device desi... | A PBS (Pencil Beam Scanning) irradiation may pause for different reasons. After a pause, irradiat... | Class II | Ion Beam Applications S.A. |
| Apr 10, 2017 | Elecsys PreciControl Varia 3 | e-barcode and value sheet for PreciControl Varia contains a typographical error for the target va... | Class II | Roche Diagnostics Corporation |
| Apr 10, 2017 | eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intend... | Some anomalies have been identified during manufacturing controls. | Class II | bioMerieux, Inc. |
| Apr 10, 2017 | CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units eac... | B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential f... | Class II | B Braun Medical Inc |
| Apr 10, 2017 | RAPIDPoint¿ 500 Blood Gas Analyzer with v2.4 software for professional use in... | Potential Patient Demographic Error with Blank Patient ID Field | Class II | Siemens Healthcare Diagnostics Inc |
| Apr 7, 2017 | Exactech Optetrak Logic CC 15mm Tibial Augment Screws | Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged ... | Class II | Exactech, Inc. |
| Apr 6, 2017 | Fellows "Mighty 8" Power strip (Part Number 04175-0008) and TrippLite Power s... | Merge is conducting a hardware recall (replacement) of Fellows "Mighty 8" Power Strip and TrippLi... | Class II | Merge Healthcare, Inc. |
| Apr 6, 2017 | 01.4mm x 457mm (18in) K-Wire, Threaded Blunt, Ref 9080B-18T, Qty: 1 per pack... | Mislabeled guide wires - It was discovered that some Guide Wires labeled as stainless steel were ... | Class II | Amendia, Inc |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog ... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 5, 2017 | DOLPHIN INFLATION DEVICE CALIBER INFLATION DEVICE; Catalog Number: CL3030- 01... | Complaints regarding broken blister. | Class II | PEROUSE MEDICAL |
| Apr 5, 2017 | The JETSTREAM is a rotational atherectomy catheter system designed for use in... | Boston Scientific is initiating a voluntary removal of two lots of JETSTREAM SC 1.85mm and one lo... | Class II | Boston Scientific Corporation |
| Apr 5, 2017 | SoftPort Easy-Load Lens Delivery System Model: EZ-28V Is used for the foldi... | Complaints concerning kinked haptics that were occurring during lens delivery. | Class II | Bausch & Lomb Surgical, Inc. |
| Apr 5, 2017 | ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 0223... | Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than... | Class II | Siemens Healthcare Diagnostics, Inc |
| Apr 4, 2017 | "Free and Total Protein S ELISA Kit" Cat. No. 5292 For use in the quantitatio... | Internal components of the Protein S ELISA Antigen Kit (Lot: 3-16-5292) were mislabeled. The Pro... | Class II | Helena Laboratories, Inc. |
| Apr 4, 2017 | Jelco, Hypodermic needle Pro¿ needles 19G X1 1/2" 800/CA Model No. EL 1915 &... | Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medica... | Class II | Smiths Medical ASD Inc. |
| Apr 4, 2017 | MicroVue CIC-C1q EIA, Model A001. An enzyme immunoassay for the detection of... | There is a potential for the slope of the standard curve to fail to meet the assay validation req... | Class II | Diagnostic Hybrids, Inc. |
| Apr 4, 2017 | Ellex Tango Reflex with slit lamp Laser Ophthalmic In the SLT mode, the d... | It was discovered the unit produced a laser emission without pressing the fire button when the sl... | Class II | Laserex Systems Inc. |
| Apr 3, 2017 | Lactate Reagent (LACT 2 x 50), Catalog No. A95550 Intended for the quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Uric Acid Reagent (URIC 2 x 300), Catalog No. 442785. Intended for the qua... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Triglycerides Reagent (TG 2 x 300), Catalog No. 445850. Intended for quant... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | AQUIOS CL Flow Cytometer, Ref no. B30166, Software Versions 2.0 and 2.0.1 ... | Beckman Coulter has confirmed that the Export feature located in the Results area of the AQUIOS S... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Cholesterol Reagent(CHOL 2 x 300), Catalog No. 467825 Intended for quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Second generation neoBLUE LED Phototherapy Light (neoBLUE 2) sold between 200... | The second generation neoBLUE 2 lights with a black band, sold from 2003 to 2008, are recalled so... | Class II | Natus Medical Incorporated |
| Apr 3, 2017 | HDL Cholesterol Reagent (HDL 2 x 200), Catalog No. A15625. Intended for qu... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI ... | Product sterility compromised due to breach in sterile barrier package | Class II | Mederi Therapeutics, Inc |
| Apr 3, 2017 | Salicylate Reagent (SALY 2 x 45), Catalog No. 378194. Intended for quantit... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 3, 2017 | Solus Flexible wire-reinforced laryngeal mask airways under the following siz... | A defect in the wire-reinforced tubing may result in a partial of total occlusion when the cuff i... | Class II | Intersurgical Inc |
| Apr 3, 2017 | Enzymatic Creatinine Reagent (CR-E 2 x 200), Catalog No. A60298. Intended ... | Beckman Coulter has identified the following drugs as potential sources of interference: Metamizo... | Class II | Beckman Coulter Inc. |
| Apr 1, 2017 | Healon V, Part No. 10290045 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon Duet, Part No. 10290080, 10220010, 10220011 and 10220012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon, Part No. 10290953, 10295210, 10200011, 10200012, 10201012, 10203012, ... | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon 5 Pro, Part No. 10270015 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon Pro, Part No. 10270012 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Apr 1, 2017 | Healon GV, Part No. 10294701, 10294801, 10200014, 10201014, 10202014, 10203014 | Remote possibility that certain solutions in these lots may contain microscopic glass particles d... | Class II | Abbott Medical Optics Inc. (AMO) |
| Mar 31, 2017 | ATAR Reusable Extension Cable, sold under brand names: ATAR Reusable Series, ... | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Oscor, Inc. |
| Mar 31, 2017 | Endopath ETS-FLEX Endoscopic Articulating Linear Cutter, VASCULAR/THIN 35MM | There is a risk that the pinion gear in the device could fail under extreme use cases. | Class II | Ethicon Endo-Surgery Inc |
| Mar 31, 2017 | ATAR Disposable Extension Cable, sold under brand names: ATAR Disposable Seri... | The Reusable Oscor ATAR extension cables could separate from the connector during use. | Class I | Oscor, Inc. |
| Mar 31, 2017 | Arctic Sun 5000 Temperature Management System, 100-120 V North America and 10... | Potential failure of the Arctic Sun 5000 Temperature Management System may occur when the continu... | Class II | C.R. Bard, Inc. |
| Mar 31, 2017 | da Vinci Xi EndoWrist Suction Irrigator, 8 mm instrument; PN 480299-03; and ... | Intuitive Surgical has become aware that in specific scenarios with system software P6 and the da... | Class II | Intuitive Surgical, Inc. |
| Mar 30, 2017 | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 12 MM, REF 71369412, STERILE R... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, ROUNDED END, THIN OSTEOTOME BLADE, 20 MM, REF 71369420, STERILE R... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 12, REF 71369312, STERILE R, QTY: (1) | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, Inc. |
| Mar 30, 2017 | Newport Medical HT70 and HT70- Plus Ventilators, Rx Only Product Usage: T... | Medtronic is issuing a voluntary field corrective action for all its Newport" HT70 and Newport" H... | Class I | Newport Medical Instruments Inc |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106015 - HMII LVAD SEALED KIT-PC... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | If Hip, Sterile Polar Dressing P/N 10680 Product Usage: These products ar... | They may not have been sealed prior to sterilization. Products with unsealed pouches will be non... | Class II | Breg Inc |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 106762 - HMII POCKET CONTROLLER,... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | HeartMate¿ II LVAS with Pocket Controller; 107801 - HMII PUMP & POCKET CTRL... | St. Jude Medical is providing all users of their HeartMate II LVAS with Pocket Controller with ne... | Class I | Thoratec Corporation |
| Mar 30, 2017 | RENOVATION, THIN OSTEOTOME BLADE, 20 MM X 3 INCH, REF 71369220, STERILE R, QT... | The stability data does not support the product labeled with a 10-year shelf life. | Class II | Smith & Nephew, 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.