Browse Device Recalls
5,543 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,543 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 5,543 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 7, 2012 | CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... | Class II | Civco Medical Instruments Inc |
| May 7, 2012 | CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... | Class II | Civco Medical Instruments Inc |
| May 7, 2012 | CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... | Class II | Civco Medical Instruments Inc |
| May 7, 2012 | USA-002 Rev A brochure is a two sided tri-fold printed marketing brochure des... | Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... | Class II | Non-Invasive Monitoring Systems, Inc. |
| May 7, 2012 | CIVCO General Purpose Sensor, Non-sterile reusable general purpose electromag... | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... | Class II | Civco Medical Instruments Inc |
| May 7, 2012 | CIVCO VirtuTRAX Instrument Navigator, Reusable non-sterile general purpose dr... | The general purpose electromagnetic sensor was incorrectly calibrated causing potential variabili... | Class II | Civco Medical Instruments Inc |
| May 3, 2012 | Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROW... | Lidstock of product does not contain chlorhexidine contraindication and contains wording "contain... | Class I | Arrow International Inc |
| Apr 27, 2012 | Motorola Solutions PCS3000/CS3070 Laser Utility/Peripheral Laser Products | It was discovered the CS3000/CS3070 was manufactured using the laser power settings for a Class ... | Class II | Motorola Inc |
| Apr 26, 2012 | Lipofilter 3000, model ASP-CAN-2, labeled in part ***MicroAire, 1641 Edlich D... | Medical device was not manufactured under Good Manufacturing Procedures and a user may be unable ... | Class II | MicroAire Surgical Instruments, LLC |
| Apr 11, 2012 | AutoMate 1250 and AutoMate 2550, Part Numbers ODL25125 and ODL25255. The A... | The recall was initiated because Beckman Coulter has confirmed customer reports of secondary tube... | Class II | Beckman Coulter Inc. |
| Apr 10, 2012 | "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATE... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Apr 10, 2012 | "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVA... | Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling the S8580, 8.0MM SENTINEL Cann... | Class II | Linvatec Corp. dba ConMed Linvatec |
| Apr 4, 2012 | Pudenz Flushing Valve with Integral Connectors, catalog number NL850-1330. In... | The pouch label of catalog NL850-1330 indicates an incorrect model and closing pressure of the de... | Class II | Integra LifeSciences Corp |
| Apr 2, 2012 | MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable... | Product was packaged with the incorrect port and does not match the label. The kit is labeled as... | Class II | Medical Components, Inc dba MedComp |
| Mar 29, 2012 | MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Inten... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. In... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are includ... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Inte... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. I... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 29, 2012 | MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. In... | The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutti... | Class II | The Anspach Effort, Inc. |
| Mar 28, 2012 | Fast-Cath Transseptal Guiding Introducer, 90, 8F, REF 406586, Length 60 cm, S... | St. Jude Medical is recalling a single batch of Fast Cath Transseptal Guiding Introducers which w... | Class III | St Jude Medical Inc |
| Mar 14, 2012 | Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: Ult... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 14, 2012 | UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: ... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 14, 2012 | UltraFill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: U... | Surgical Tissue Network Inc., DBA TissueNet Inc. recalled their UltraFill DBM Putty-Porcine (1 cc... | Class II | Surgical Tissue Network, Inc. |
| Mar 12, 2012 | DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated Handpie... | Product may have wrong large product identification label with symbols on the box indicating a S9... | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Mar 7, 2012 | Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner, Ref 1221-36-452 ... | DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX" liner be... | Class II | DePuy Orthopaedics, Inc. |
| Feb 24, 2012 | Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage... | During the real-time stability testing for the cobas KRAS Mutation Test on the commercial lot PO6... | Class III | Roche Molecular Systems, Inc. |
| Feb 8, 2012 | The finger cots are made out of natural rubber. They are disposable products... | The firm is initiating a field correction because the product(s) were missing the Latex Warning L... | Class II | Afassco Inc |
| Feb 6, 2012 | CaviCide, Part Numbers: 13-1025, 13-1000, 13-1024, MC-1000. Alternate bra... | Metrex Research is recalling Cavicide containing the Spring Fresh Fragrance because the affected ... | Class II | Metrex Research, LLC. |
| Feb 5, 2012 | Plum A+ Hyperbaric Infusion Pump; List Number 11005; Labeled in part:... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Feb 5, 2012 | *** 1) Plum A+ Infusion Pump; List Number: 20678; Labeled in part: PL... | Hospira has received reports of distal pressure sensor calibration drift on Plum A+ Infusers. The... | Class II | Hospira Inc. |
| Dec 15, 2011 | Synchron Systems Synchron Calibrator Multi Calibrator Diskettes, Part Number ... | The recall was initiated because Beckman Coulter has confirmed a mislabeling error, some Synchron... | Class III | Beckman Coulter Inc. |
| Nov 4, 2011 | Implant, Dental, Endosseous, Acid Etched, ICE, Osseotite, Internal Connection... | On November 3, 2011 Biomet 3i, Palm Beach Gardens, FL initiated a recall of their Osseotite Certa... | Class II | Biomet 3i, LLC |
| Oct 21, 2011 | GE Healthcare, Innova 2100IQ, Innova 3100IQ, Innova 4100IQ, Cardiovascula... | As part of GE Innova IQ table introduction, a label was designed to be affixed on the front Cover... | Class II | GE Healthcare, LLC |
| Sep 23, 2011 | UltraFlow HPC Flow Directed Micro Catheter, Model # 105-5065. Product Usag... | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
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.