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 |
|---|---|---|---|---|
| Jan 25, 2017 | Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packa... | Quidel Corporation is recalling Influenza Transport Swab Packages because it may include an incor... | Class II | Quidel Corporation |
| Jan 25, 2017 | SRHS DeRoyal Heart Tracecart REF 53-1913, Rx Only, NON-STERILE PRODUCT CONTAI... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Jan 25, 2017 | MEVATRON KD-2, accelerator, Linear, Medical The intended use of the SIEMENS ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | The UNI-CP System; Model Number: 330230SND. | The firm received one complaint from one non-US sales representative (France) that the label on t... | Class III | Integra LifeSciences Corp. |
| Jan 25, 2017 | MEVATRON MD-2, MEVATRON MDX-2 and MEVATRON ME, accelerator, Linear, Medical ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible O... | Mislabeling. The packaging labeled as left mandible contained a right mandible. | Class II | Matrix Surgical Holdings, LLC |
| Jan 25, 2017 | MEVATRON M 6730/6740 (MEX) Accelerator, Linear, Medical The intended use of ... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | MEVATRON M 7400/7440(MEX) Accelerator, Linear, Medical The intended use of t... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS Medical charged-particle radiation therapy system Product Usage: T... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | PRIMUS HI and Mevatron M2/Primus Mid-Energy, Accelerator, Linear, Medical Th... | Siemens became aware of a defective weld seam at overhead suspensions. Due to this defect it is p... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | DeRoyal Heart Tracecart REF 53-1769, Rx Only, NON-STERILE PRODUCT CONTAINED W... | DeRoyal manufactured custom tracecarts containing a sterile Maquet Getinge Group chest drainage p... | Class III | DeRoyal Industries Inc |
| Jan 25, 2017 | ARTISTE MV System, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 25, 2017 | ONCOR Avant-garde, medical charged-particle radiation therapy system Produ... | Siemens became aware of Incorrect values for the rotational collimator position displayed due to ... | Class II | Siemens Medical Solutions USA, Inc |
| Jan 23, 2017 | XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targete... | When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wir... | Class II | Strata Skin Sciences, Inc. |
| Jan 23, 2017 | Premier Guard Sterile Drape For Use with Blair-Port Wand (02-0029) and Blair-... | Sterility compromised due to breach in sterile barrier | Class II | Covidien LLC |
| Jan 23, 2017 | Merge LIS | A defect in the software resulted in medications that are not associated with the patient (i.e., ... | Class II | Merge Healthcare, Inc. |
| Jan 23, 2017 | RTI Biologics BioSet IC RT Paste 2 cc Filler, bone void, calcium compound.... | Incorrect instructions for use (IFU) included. | Class II | RTI Surgical, Inc. |
| Jan 23, 2017 | Premier Guard Drape, Sterile. For Use with Verisphere (01-0035) and ArQ.Sphe... | Sterility compromised due to breach in sterile barrier | Class II | Covidien LLC |
| Jan 20, 2017 | Integra Cadence Total Ankle System | Posterior tibial fractures have been reported. | Class II | Integra LifeSciences Corp. |
| Jan 20, 2017 | Discovery MR450 The systems are whole body magnetic resonance scanners des... | Potential safety issue with the patient bore heating on the Discovery MR450 narrow bore 1.5T MRI.... | Class II | GE Healthcare, LLC |
| Jan 20, 2017 | Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010 | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... | Class II | Atrium Medical Corporation |
| Jan 20, 2017 | CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is Cav... | Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the ... | Class II | Metrex Research, LLC. |
| Jan 20, 2017 | Blastomyces dermatitidis Antiserum 1 mL vial GIBSON BIOSCIENCE. Catalog 2002... | The firm information that the product was reporting false positive results | Class II | Gibson Laboratories LLC |
| Jan 20, 2017 | Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008 | Labeling icon depicts a catheter having six (6) eyelets; however the correct number of eyelets o... | Class II | Atrium Medical Corporation |
| Jan 19, 2017 | AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointesti... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 19, 2017 | 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pe... | The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titani... | Class II | Acumed LLC |
| Jan 19, 2017 | AMT 12 inch Right Angle Feeding Set with Y-Port Used with Nasogastric/Naso... | Expired expiration dates are listed on the pouches. | Class III | Applied Medical Technology Inc |
| Jan 18, 2017 | Philips Healthcare Brilliance iCT SP X-Ray, Tomography, Computed These ... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G x 4 MAX Intended for... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 18, 2017 | Philips Healthcare Brilliance 64 System, X-Ray, Tomography, Computed These... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity Core X-Ray, Tomography, Computed These compu... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity Core128 X-Ray, Tomography, Computed The... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | Philips Healthcare Ingenuity CT X-Ray, Tomography, Computed These comp... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 18, 2017 | T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEED... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 18, 2017 | Radiation Therapy Treatment Planning System, Model 4.5, 4.7, 5.0 RayStation ... | An error in NVIDIA GPU (Graphics Processing Unit) card drivers can occur for certain software pro... | Class II | RAYSEARCH LABORATORIES AB |
| Jan 18, 2017 | ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is... | Potential performance issues. False Susceptible result instead of Intermediate and False Interme... | Class II | BioMerieux SA |
| Jan 18, 2017 | HARVEST NEEDLE 15GA X 2 Intended for the purpose of harvesting bone and/or... | The recalling firm received a complaint from one of their customers of a potential defect in the ... | Class II | Argon Medical Devices, Inc |
| Jan 18, 2017 | Philips Healthcare Brilliance iCT X-Ray, Tomography, Computed These co... | During a bolus tracking procedure, no images were generated when the scan was completed, and the ... | Class II | Philips Electronics North America Corporation |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV16F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV32F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV23F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | Video Duodenoscope These instruments are intended to provide optical visua... | Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope t... | Class II | Pentax of America Inc |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV13F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | Medtronic Strata II / Strata NSC Valves (includes Burr Hole and Lumbar Perito... | Medtronic Neurosurgery initiated a recall after receiving five (5) Product Experiences between Fe... | Class II | Medtronic Neurosurgery |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV19F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 17, 2017 | Philips Efficia CMS200 Central Monitoring System; 863352 The Efficia CMS200 ... | The monitor may not alarm appropriately for a pediatric or neonatal patient. | Class II | Philips Electronics North America Corporation |
| Jan 17, 2017 | ECMO Reinforced Dual Lumen Cannula, Sterile EO, Rx Only, REF: VV28F | Clamping the clear tube very close to the blue hub may cause a localized adhesive failure in the ... | Class I | OriGen Biomedical, Inc. |
| Jan 16, 2017 | BD Vacutainer Buffered Sodium Citrate: (9NC) Blood Collection Tube (4.5 ml x... | A portion of this lot of blood collection tubes was manufactured with approximately twice the exp... | Class II | Becton Dickinson & Company |
| Jan 16, 2017 | LIFEPAK 15 Monitor/Defibrillator with End-Tidal CO2 option. Intended f... | The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during... | Class II | Physio-Control, 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.