Browse Device Recalls
2,729 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,729 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 2,729 FDA device recalls in 2014.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 8, 2014 | Panaroma Central Station Product Usage: This device can view real time,... | Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jan 7, 2014 | AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravas... | Defective component may cause extension sets to leak. | Class II | Churchill Medical Systems, Inc. |
| Jan 7, 2014 | Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended f... | The Drill Template and the Saw Guide for the Ulna Osteotomy System may exhibit jamming, bending, ... | Class II | Synthes, Inc. |
| Jan 7, 2014 | Synthes Driving Cap/Threaded Both parts are intended for use in the Tibia ... | The Synthes Driving Cap/Threaded can bind in the IM Nail Radiolucent Insertion Handles when assem... | Class II | Synthes, Inc. |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cer... | The products have been identified to contain springs which have been manufactured with type-304 s... | Class II | Exactech, Inc. |
| Jan 6, 2014 | Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An... | Complaints were received regarding Quality Control (QC) shifts with Pseudocholinesterase (PCHE) a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Jan 6, 2014 | Medtronic GRAFTON (R) DBM, Flex 2.5cm x 10cm, REF T42100, Rx only, STERILE A,... | Product was labeled as being measured as 2.5 cm x 10 cm, but contained product that measured as 2... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 6, 2014 | Infantino Squeeze & Teethe Monkey, "Go Gaga Squeeze & Teether Coco the Monkey... | Infantino initiated this voluntary recall of all lots of Infantino Squeeze & Teethe Monkey, "Go G... | Class II | Infantino LLC |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | Atlantis PV, 8.5F, 15 MHz Peripheral Imaging Catheter: Sterile, R; Steriliz... | Reports of physicians experiencing inability to pass a 0.035" guidewire through the guidewire lum... | Class II | Boston Scientific Corporation |
| Jan 6, 2014 | Tapered Screw-Vent Implant, MTX, 4.7mm x 11.5mm, 4.5mm Platform. Catalog Numb... | Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant,... | Class II | Zimmer Dental Inc |
| Jan 6, 2014 | cobas¿ PCR Urine Kit 100 PKT IVD cobas¿ PCR Female Swab Kit 100 PKT IVD cob... | Numerous complaints have been filed that leaking cobas ¿ PCR media 4.3 mL IVD have been received ... | Class II | Roche Molecular Systems, Inc. |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 9.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 3, 2014 | SET SCREW RETAINING DRIVER, REF 9010000820, QTY: 1 EA, Medtronic Sofamor Dane... | The retaining tabs component of the Set Screw Retaining Drive may be oversized, which will not al... | Class II | Medtronic Sofamor Danek USA Inc |
| Jan 3, 2014 | Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P ... | Product labeling does not match product configuration. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Jan 3, 2014 | Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Me... | Product labeling does not match product configuration. | Class II | Davol, Inc., Subs. C. R. Bard, Inc. |
| Jan 1, 2014 | i-STAT G3+ Cartridge pH, pCO2 and pO2 measurements are used in the diagnos... | Abbott Point of Care has determined that some individual patient results generated with the i-ST... | Class II | Abbott Point Of Care 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.