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 |
|---|---|---|---|---|
| Mar 5, 2015 | GE Healthcare Millennium VG, Discovery VH and VariCam Nuclear Medicine system... | GE Healthcare has recently become aware of a potential safety issue due to a collimator falling o... | Class II | GE Healthcare |
| Mar 5, 2015 | Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi ... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Merge LIS software. | There is a potential for duplicate container numbers to be created for patients. | Class II | Merge Healthcare, Inc. |
| Mar 5, 2015 | Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Sony Medical Monitor LMD-1951MD 19 inch | Monitor has either not turned on or has lost image during clinical use. | Class II | Sony Latin America |
| Mar 5, 2015 | Direct Water feed Kit, Catalog#10373222 | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are ... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 5, 2015 | CODMAN 3000 Series Refill Set- Huber needles. Used in combination with the C... | Needle is leaking from hub/needle cannula connection | Class II | Codman & Shurtleff, Inc. |
| Mar 5, 2015 | SpineFrontier MISquito Percutaneous Pedicle Screw System Surgical Technique... | The PedFuse Pedicle Screw Rod Caliper included with the MISquito Pedicle Screw System may be used... | Class II | SpineFrontier, Inc. |
| Mar 5, 2015 | Spacelabs Pediatric Flow Sensor Kit, PN: 376-0561-00. This kit is for Spacela... | Reports of inaccurate low flow readings. Monitored inspiratory tidal volume (VTi) and expiratory ... | Class II | Del Mar Reynolds Medical, Ltd. |
| Mar 5, 2015 | Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 sy... | The bottle assemblies were manufactured with a quality issue where in some cases the smaller diam... | Class II | Siemens Medical Solutions Diagnostics |
| Mar 4, 2015 | LP Rotate Foot System prosthetic device for fitting lower extremity amputati... | The threads of the outer tube of the shock module of LP Rotate are too short, resulting in insecu... | Class II | Ossur H / F |
| Mar 4, 2015 | LCS COMPLETE RPS Femoral Implants, various sizes and orientation. Knee prost... | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... | Class II | DePuy Orthopaedics, Inc. |
| Mar 4, 2015 | Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shi... | The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack... | Class II | Hardy Diagnostics |
| Mar 4, 2015 | RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, Ra... | An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is ... | Class II | RAYSEARCH LABORATORIES AB |
| Mar 4, 2015 | LCS COMPLETE RPS inserts, various sizes. Knee prosthesis component for orthop... | The LCS COMPLETE RPS Knee System has higher rates of revision in Australia when the native patell... | Class II | DePuy Orthopaedics, Inc. |
| Mar 4, 2015 | Diamondback 360 Coronary Orbital Atherectomy System, Model Number: DBEC-125. ... | The OAD saline sheath outer layer may flake off from the catheter due to friction between the out... | Class I | Cardiovascular Systems, Inc. |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; ASSY,USM,IS4000, Material number: 3806... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; Assy, Distal SUJ, Inner, IS4000 Materi... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Mar 3, 2015 | da Vinci Xi Surgical System, IS4000; ASSY,DISTAL SUJ,OUTER,IS4000, Material... | Correction due to a fault that causes distal SUJ (DSUJ) failures that indicates a mismatch betwee... | Class II | Intuitive Surgical, Inc. |
| Mar 2, 2015 | The FLOW-i Anesthesia System Axillary O2 and Suction Module, Device Part numb... | Maquet has identified that in some FLOW-i Anesthesia System Auxiliary O2 and Suction Modules, the... | Class II | Maquet Cardiovascular Us Sales, Llc |
| Mar 2, 2015 | Master Drug Library Software version 8.0, Product Code 35723V080, to be used ... | Loading/Bolus default dose settings in the Master Drug Library and the values shown on the pump d... | Class II | Baxter Healthcare Corp |
| Mar 2, 2015 | Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece. | The metal cannula attached to the handpiece can rotate and become dislodged from the plastic hand... | Class II | Hill-Rom, Inc. |
| Feb 27, 2015 | Lombart 90D Clear with case Visualization during diagnosis and laser therapy... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct l... | Class III | Volk Optical Inc |
| Feb 27, 2015 | GE Healthcare, Aespire 7900, Aespire View Anesthesia Machines. Model numbers... | Specific Aespire 7900 Anesthesia Machines have an increased likelihood of failure of the CPU circ... | Class II | GE Healthcare |
| Feb 27, 2015 | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL IN... | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. | Class III | Volk Optical Inc |
| Feb 27, 2015 | Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extend... | Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 ... | Class II | Stryker Howmedica Osteonics Corp. |
| Feb 26, 2015 | CIVCO Surgi-Tip Transducer Cover Sterile (15.2 x 244 cm) polyethylene telesco... | Leaks were detected in the recalled lot which may compromise the sterility of the product. | Class II | Civco Medical Instruments Inc |
| Feb 26, 2015 | ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligame... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, Inc. |
| Feb 26, 2015 | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable syst... | The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were n... | Class II | Biomet, Inc. |
| Feb 26, 2015 | The Rheo Knee bionic prosthetic is to be used exclusively for fittings of low... | The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal a... | Class II | Ossur H / F |
| Feb 26, 2015 | ENDOPATH ECHELON" Vascular White Reload for Advanced Placement Tip, Produ... | During an internal inspection of the production process the firm discovered an issue which may ca... | Class II | Ethicon Endo-Surgery Inc |
| Feb 26, 2015 | LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthal... | Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels | Class II | Quest Medical, Inc. |
| Feb 26, 2015 | Vitagel; indicated in surgical procedures (other than in neurosurgical and op... | Several shipments of Vitagel product (a surgical hemostat) required to be stored at 2 -8 degrees ... | Class II | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Feb 25, 2015 | Vitek 2 AST-P641 REF 418 590 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Amerigel Hydrogel Gauze Dressing 2 x 2, A5002. Wound Management. | Nonapproved labeling claims (Sterile) | Class II | Amerx Health Care Corp. |
| Feb 25, 2015 | Vitek 2 AST-P635 REF 416 911 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | LASSO NAV Duo Loop eco Catheters, Catalog No. D-1354-01, D-1354-02, D-1354-03... | Biosense Webster is recalling the LASSO NAV Duo Loop eco Catheters because of reports of difficul... | Class II | Biosense Webster, Inc. |
| Feb 25, 2015 | Vitek 2 AST-P640 REF 418 579 Gram Positive Susceptibility Card, 20 cards per ... | The outer carton label and package insert for the recalled product incorrectly lists Streptococcu... | Class III | Biomerieux Inc |
| Feb 25, 2015 | Boston Scientific: Expel" Drainage Catheter with Twist-Loc" Hub APDL Drainag... | Boston Scientific is initiating this Medical Device Field Correction of the Expel" APD and APDL ... | Class II | Boston Scientific Corporation |
| Feb 25, 2015 | Various Lots of Expel Drainage Catheter with TwistLoc Hub Biliary Drainage Ca... | Complaints of device fragmentation after the catheter was implanted in the biliary system. The mo... | Class II | Boston Scientific Corporation |
| Feb 25, 2015 | Captiva's lumbar intervertebral fusion system Reamers (color code rings on th... | It is possible for the titanium color-coded ring to detach from the Reamers. | Class II | Captiva Spine, Inc |
| Feb 24, 2015 | QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on... | A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Feb 24, 2015 | Skintact ECG Electrode FS-50, Catalog no. 58028 , & Stable Base ECG Electro... | The electrodes may fail to transmit signals. | Class II | Leonhard Lang Medizintechnik GmbH |
| Feb 24, 2015 | Synthes 130 Degree Aiming Arm and 125 Degree Aiming Arm; The 130 Degree Aimin... | The guide sleeve has the potential to jam in the Aiming Arms, which may delay disassembly and rem... | Class II | Synthes, Inc. |
| Feb 24, 2015 | LeMaitre Vascular Tumescent Catheter Inversion (TCI) System. The TCI Syste... | Mislabeled with an incorrect expiration date | Class III | LeMaitre Vascular, Inc. |
| Feb 23, 2015 | Mobius3D Product Usage: Mobius3D software is used for quality assurance a... | Mobius3D version 1.5.0 contained a defect in software code which affects users who perform beam c... | Class II | Mobius Medical Systems, LP |
| Feb 23, 2015 | RECLAIM Assembled Implant Inserter Adaptor orthopedic manual surgical instru... | This lot of the RECLAIM Assembled Implant Inserter Adaptor Instrument may fracture during surgery... | Class II | DePuy Orthopaedics, Inc. |
| Feb 23, 2015 | Medtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath... | Clinicians observed debris, appearing to originate from the hemostasis valve on the proximal end ... | Class I | Medtronic Inc. Cardiac Rhythm Disease Management |
| Feb 20, 2015 | Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E)... | The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L... | Class II | ArthroCare Medical Corporation |
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.