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 |
|---|---|---|---|---|
| Jul 21, 2015 | CrossCHECK Non-Locking Screw in the following sizes: 3.0 x 8 mm, REF CCP-N300... | These screws have a potential of passing through the plate in the case when torque is applied in ... | Class II | Wright Medical Technology, Inc. |
| Jul 20, 2015 | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and PowerPICC¿ SOLO¿ cath... | Class II | Bard Access Systems |
| Jul 20, 2015 | Titan Spine Endoskeleton Locking Bone Screw Assembly, which is part of the En... | Titan Spine is recalling specific Endoskeleton TCS Integrated Locking Bone Screw Assembly due to ... | Class II | TITAN SPINE, LLC |
| Jul 20, 2015 | 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw Syste... | The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the g... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | 2.0/2.4 Cannulated Screw Countersink Part # 210-24-002 NON-STERILE and 3.0/4.... | The cutting efficiency of the Countersinks was out of specification. | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | Neptune 2 Waste Management System Docking Station (120V and 230V), New and Re... | The Fluid Coupling Sleeve, a component within the Neptune Waste Management System Docker, may be ... | Class II | Stryker Instruments Div. of Stryker Corporation |
| Jul 20, 2015 | Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Hea... | Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported t... | Class II | Trilliant Surgical Ltd. |
| Jul 20, 2015 | Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, ... | The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to... | Class II | Trilliant Surgical Ltd. |
| Jul 19, 2015 | Elcam Medical Minimal Residual Volume Luer activated Swabbable stopcock (MRVL... | Punctured blister packages were detected during the packaging process at the manufacturing site. ... | Class II | Elcam Medical, Inc. |
| Jul 19, 2015 | Elcam Medical MANI 3G Plate BLS RAD B.BRAUN; Manifold for pressure monitoring... | Punctured blister packages were detected during the packaging process at the manufacturing site. ... | Class II | Elcam Medical, Inc. |
| Jul 17, 2015 | MicroScan LabPro Information Manager System, Version 1.0 to Version 4.11, Cat... | The software incorrectly allows the operator to manually edit the carbohydrate substrates when ma... | Class II | Beckman Coulter Inc. |
| Jul 17, 2015 | Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Steriliz... | Advanced Sterilization PRoducts (ASP) is recalling the Wall Chart for STERRAD 100NX System becaus... | Class II | Advanced Sterilization Products |
| Jul 17, 2015 | Medtronic Passive Biopsy Needle Kit, Part Number 9733068 - Passive Biopsy Nee... | The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing ... | Class II | Medtronic Navigation, Inc. |
| Jul 17, 2015 | Medtronic Passive Biopsy Needle Kit, Part Number 9731754 - Passive Biopsy Fee... | The adhesive between the sphere assembly and the biopsy needle shaft may be compromised, causing ... | Class II | Medtronic Navigation, Inc. |
| Jul 17, 2015 | BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 33580... | Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody whi... | Class II | Becton, Dickinson and Company, BD Biosciences |
| Jul 17, 2015 | PET Discovery ST 16 | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... | Class II | GE Healthcare |
| Jul 17, 2015 | PET Discovery LS | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... | Class II | GE Healthcare |
| Jul 17, 2015 | Lightspeed 16 CT | Potential for expulsion of the Power Supply on Lightspeed CT scanner or Discovery ST PET CT or Di... | Class II | GE Healthcare |
| Jul 17, 2015 | LYFO Disk | LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Cat... | Class III | Microbiologics Inc |
| Jul 16, 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jul 16, 2015 | Radiometer Fixation Kit N20 for the TCM CombiM monitoring system, REF 905-873... | When the fixation ring is taken off the paper liner there is a potential for fractions of the pap... | Class II | Radiometer America Inc |
| Jul 16, 2015 | Naturalyte Liquid Bicarbonate Concentrate 6.4 liter bottle A Dialysate Conce... | Expansion of recall to lots manufactured in 2015 due to the potential for bacterial contamination. | Class II | Fresenius Medical Care Holdings, Inc. |
| Jul 16, 2015 | Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic ... | Otto Bock Healthcare GmbH is voluntarily recalling all 3R62 Pheon polycentric prosthetic knee joi... | Class II | Otto Bock Healthcare GmbH |
| Jul 16, 2015 | Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking ... | The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector. | Class II | Mako Surgical Corporation |
| Jul 15, 2015 | iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3... | Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-boa... | Class II | Iris Diagnostics |
| Jul 15, 2015 | Dimension¿ CREA (Creatinine) and Dimension Vista¿ CREA (Creatinine); The CRE... | Siemens has confirmed that the Dimension CREA and Dimension Vista CREA may produce falsely depres... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jul 15, 2015 | EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-... | Medtronic is recalling the EnVeo R Loading Systems because of the presence of particulate. | Class I | Medtronic Cardiovascular Surgery-the Heart Valv... |
| Jul 14, 2015 | Biograph mCT X-4R, Model Number 10248670 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD... | Ortho Solutions Inc is initiating a recall on behalf of UltOS 3.5mm locking screw. The locking th... | Class II | Ortho Solutions Inc |
| Jul 14, 2015 | Biograph mCT Flow Edge-4R, Model Number 10528955 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Histolock Resection Device, US Endoscopy. An electrosurgical device desig... | The company has determined the sterility cannot be assured for the affected lot. | Class II | US Endoscopy Group Inc |
| Jul 14, 2015 | cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas ... | Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2015 | SYS IVK, Bio mCT-S(40) 3R->4R, Model Number 10250743 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas ... | Low PO2 results. QC failures of the PO2 parameter, affecting primarily Levels 1 and 2, caused b... | Class II | Roche Diagnostics Operations, Inc. |
| Jul 14, 2015 | Biograph mCT S(40)-4R, Model Number 10248671 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Biograph 64-4R TruePoint w/ TrueV, Model Number 10097302 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Biograph mCT S(64)-4R, Model Number 10248672 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Biograph 6-4R TruePoint w/ TrueV, Model Number 10097290 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 14, 2015 | Biograph 64-3R TruePoint w/ TrueV, Model Number 10097301 | Emission computed tomography systems and computed tomography xray systems with optional ceiling m... | Class II | Siemens Medical Solutions USA Inc. |
| Jul 13, 2015 | PS500 of an IACS Workstation Critical Care (Evita Infinity V500); intended fo... | The battery capacity of the optional PS500 of an IACS Workstation Critical Care (Evita Infinity V... | Class I | Draeger Medical, Inc. |
| Jul 13, 2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Cat... | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... | Class I | Insulet Corporation |
| Jul 13, 2015 | RadPro 40kW Digital X-Ray Panel and Mobile/Portable Diagnostic X-Ray. Inte... | Electrostatic energy may be stored in Systems that can cause a short-cicuit which, in turn, can g... | Class II | Sedecal S.A. |
| Jul 13, 2015 | OmniPod¿ Insulin Management System. Only the OmniPod¿ device is affected. Ca... | OmniPods¿ (Pods) have a higher rate of failure causing: Cannula fails to deploy/retract causing ... | Class I | Insulet Corporation |
| Jul 12, 2015 | Etac Relax wall mounted shower seat The Etac Relax is a wall mounted shower ... | The recalling firm has received reports of a malfunction of the Relax wall mounted shower seat wh... | Class II | Etac Supply Center Ab |
| Jul 10, 2015 | LAPAROSC CHOLE 3/CS Used by medical staff to perform surgical procedures... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, Inc |
| Jul 10, 2015 | LAPAROTOMY PACK CUSTOMED 7/CS Used by medical staff to perform surgical p... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, Inc |
| Jul 10, 2015 | SHOULDER PACK CUSTOMED 3/CS Used by medical staff to perform surgical proc... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, Inc |
| Jul 10, 2015 | SKIN STAPLE REMOVER KIT 80/CS Used by medical staff to perform surgical p... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, Inc |
| Jul 10, 2015 | ANGIOGRAPHY PK 4/CS Used by medical staff to perform surgical procedures an... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, Inc |
| Jul 10, 2015 | UROLOGY PK 5/CS Used by medical staff to perform surgical procedures and ... | Recall initiated due to inadequate validation/qualification of sterilization processes, and packa... | Class II | Customed, 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.