Browse Device Recalls
2,907 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,907 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 2,907 FDA device recalls in 2015.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 2, 2015 | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Reco... | Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard fo... | Class II | Winco Mfg., LLC |
| Apr 1, 2015 | Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the... | If a user requests slides from the LIS or TPID, then updates a request by changing the test, the ... | Class II | Dako North America Inc. |
| Apr 1, 2015 | Teleflex Medical Hudson RCI ConchaTherm Neptune Heated Humidifier, Rx Only. | Customer complaints were received of power to the unit ceasing and the display going blank. | Class II | Teleflex Medical |
| Apr 1, 2015 | Patient Handling System (Motion Control Software), Product Usage: Indica... | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS... | Class II | Viewray Incorporated |
| Mar 30, 2015 | ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a s... | Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility tha... | Class II | Baylis Medical Corp * |
| Mar 30, 2015 | VasoNova Vascular Positioning System (VPS ) G4 Console Catalog number VPS-G4... | A limited number of VPS G4 Consoles are being recalled due to noncompliance with International El... | Class II | VasoNova, Inc. |
| Mar 30, 2015 | OriGen BIOMEDICAL VV13F Reinforced Dual Lumen Catheter STERILE DISPOSABLE: DO... | Potential for clear extension tube to separate from the hub, which could result in blood loss and... | Class I | OriGen Biomedical, Inc. |
| Mar 30, 2015 | Integra Long Epidural Steroid Injection Needle (Tuohy Needle), 18 Gauge x 5 i... | A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gaug... | Class II | Integra LifeSciences Corp. d.b.a. Integra Pain ... |
| Mar 30, 2015 | Schiller AG ISA CO2 Sensor (AKA: PhaseIn Unit), Merge Part Number HW-HEMO-000... | The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is ... | Class II | Merge Healthcare, Inc. |
| Mar 30, 2015 | REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NO... | Potential for clear extension tube to separate from the hub, which could result in blood loss and... | Class I | OriGen Biomedical, Inc. |
| Mar 30, 2015 | NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protec... | Blood foaming was found during evaluation of the product. | Class II | Nipro Medical Corporation |
| Mar 27, 2015 | BBL Trypticase Soy Agar with 5% Sheep Blood (TSA II) and Chocolate II Agar (G... | BD has confirmed that one lot of TSA II and Chocolate Agar I-Plates may fail to recover Haemophil... | Class III | Becton Dickinson & Co. |
| Mar 27, 2015 | Vitek 2 AST-YS06 REF 412 610, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Mar 27, 2015 | The eCareManager system. Software intended for use in data collection, stora... | A software defect may cause incorrect medication order change. If the user decides to edit the o... | Class II | Visicu, Inc. |
| Mar 27, 2015 | AmTryke Model 1424 Community Cruiser Hand Cycle. Therapeutic tricycle. | Product is being recalled due to complaints of cracked frames. | Class II | Amtryke LLC |
| Mar 27, 2015 | Vitek 2 AST-YS01 REF 22 108, Fungal Susceptibility Card, 20 cards per carton,... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258. | Class II | Biomerieux Inc |
| Mar 27, 2015 | CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous... | There is a potential for a hole to be present in the outer tray of a limited number of pain contr... | Class II | B. Braun Medical, Inc. |
| Mar 27, 2015 | Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton... | The test kits have Out-of-Range-Low (OORL) Flucytosine QC results for Candida krusei ATCC 6258 | Class II | Biomerieux Inc |
| Mar 26, 2015 | 1/4 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Troc... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument ha... | New and validated reprocessing procedures have been issued for the Olympus TJF-Q180V duodenoscope... | Class II | Olympus America Inc. |
| Mar 26, 2015 | 1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main c... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | Diamedix Is-CMV IgG Test Kit | Product contained an incorrect substrate. | Class II | Diamedix Corporation |
| Mar 26, 2015 | 1/4 in. Curved Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | Iamin Moist Dressing and the Iamin Hydrating Gel: intended to cover a wound o... | The labeling for the Iamin family of medical devices (e.g. printed and internet text) is not cons... | Class II | PhotoMedex, Inc. |
| Mar 26, 2015 | 1/4 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Tr... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Tro... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | 1/8 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Doub... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 26, 2015 | ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item... | Complaints were received that the heat-welded seam on the wipeable belt's strap tore when force w... | Class II | Handicare USA, Inc. |
| Mar 26, 2015 | 3/16 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Dou... | Stryker Instruments is voluntarily recalling the CBCII Wound Drains and Ambulating Bulb for a pot... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Mar 25, 2015 | Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. | Device software treatment preset parameters for the XC treatment handpiece do not match the Opera... | Class II | Lumenis Limited |
| Mar 25, 2015 | Dual Delivery 4DD-1 of GYC-1000 Green Laser Photocoagulator system GYC4DD-1:... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin wit... | Recovery for assayed controls are out of assigned ranges. A drift >3 seconds in the normal APTT ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Mar 25, 2015 | Universal Charger Product Usage: The Stryker Universal Battery Charg... | The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as desi... | Class III | Stryker Instruments Div. of Stryker Corporation |
| Mar 25, 2015 | CSA Medical truFreeze Console- Cryosurgical Unit Cryogenic Surgical Device M... | TruFreeze Console caused a higher rate of liquid nitrogen (cryogen) to be delivered and may caus... | Class II | CSA Medical |
| Mar 25, 2015 | TIGERPAW System II, Part number C-TP-1507 (7 connector) The TigerPaw Sys... | Increase of field reports involving issues with the TIGERPAW System II resulting in possible tiss... | Class I | Laax, Inc. |
| Mar 25, 2015 | Endophotocoagulation Delivery 4EP-1 of GYC-1000 Green Laser Photocoagulator S... | Accessories to the GYC-1000 laser were missing Laser Aperture labels. | Class II | Nidek Inc |
| Mar 25, 2015 | TIGERPAW System II, Part number C-TP-1509 (9 connector) The TigerPaw Sys... | Increase of field reports involving issues with the TIGERPAW System II resulting in possible tiss... | Class I | Laax, Inc. |
| Mar 25, 2015 | Sentec, V-Sign Sensor 2 (REF VS-A/P/N), Reusable / Nonsterile / Waterproof, S... | SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the... | Class II | SenTec AG |
| Mar 24, 2015 | EC-5000 Excimer Laser Corneal Surgery System (EC-5000, EC 5000 CXIII, EC-5000... | Multi-stage treatment option for the EC-5000 Operator's Manual was not approved by the FDA. | Class II | Nidek Inc |
| Mar 24, 2015 | Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532... | The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive... | Class II | The Anspach Effort, Inc. |
| Mar 24, 2015 | Hamilton-G5 Ventilators with software versions V2.40/2.41 Catalog numbers fo... | Customer reports that the ventilator display can freeze. Ventilation continues but the informatio... | Class II | Hamilton Medical, Inc. |
| Mar 23, 2015 | Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Cod... | Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because i... | Class II | Bard Peripheral Vascular Inc |
| Mar 23, 2015 | Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,St... | Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 ... | Class II | Edwards Lifesciences, LLC |
| Mar 23, 2015 | Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx ... | Medtronic is conducting a voluntary recall of all former Covidien Trellis 6 and Trellis 8 Periphe... | Class II | Medtronic Inc. Cardiac Rhythm Disease Management |
| Mar 23, 2015 | Sedecal SA Mobile Diagnost w DR x-ray system | Due to a software defect, the system may sporadically apply the default x ray exposure parameters... | Class II | Sedecal USA, 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.