Browse Device Recalls
5,428 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,428 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 5,428 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 23, 2011 | Tip Cover Accessory, 8 MM, MCS, box of 10 Product Usage: The disposable T... | Clarification of existing labeling and related cautions for the tip cover accessory of the da Vin... | Class II | Intuitive Surgical, Inc. |
| Sep 23, 2011 | Marathon Flow Directed Micro Catheter, Model #105-5055. Product Usage: The... | The recall was initiated because ev3 Neurovascular has identified one lot of UltraFlow Flow Direc... | Class II | Micro Therapeutics Inc, Dba Ev3 Neurovascular |
| Sep 23, 2011 | Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED*... | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... | Class II | Exactech, Inc. |
| Sep 23, 2011 | Product is labeled in part: "***OPTETRAK RBK***TIBIAL TRAY***FINNED, CEMENT... | Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1... | Class II | Exactech, Inc. |
| Sep 20, 2011 | Pentron Clinical Metrex Research; Pinnacle Cure Sleeve, a protective barrier ... | The firm initiated the recall due to a labeling error. The boxes labeled as Pinnacle Cure Sleeve ... | Class II | Metrex Research, LLC. |
| Sep 19, 2011 | Cannula 8MM Regular. Provides the means of introduction and placement of a... | Clarification of existing labeling information and operating procedures. | Class II | Intuitive Surgical, Inc. |
| Sep 19, 2011 | Flush Port (used in almost all da Vinci instruments) Assists in cleaning t... | Clarification of existing labeling information and operating procedures. | Class II | Intuitive Surgical, Inc. |
| Sep 19, 2011 | da Vinci Si Surgeon Console. Intended to assist in the accurate Control of... | Clarification of existing labeling information and operating procedures. | Class II | Intuitive Surgical, Inc. |
| Sep 12, 2011 | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in ... | The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the lab... | Class I | Engineered Medical Systems,Inc |
| Jul 5, 2011 | Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Ge... | Mislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental Inc |
| Jul 5, 2011 | Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 ... | Mislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Estheti... | Class II | Keystone Dental Inc |
| Jul 1, 2011 | Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction T... | ConMed Linvatec recalled their 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100)... | Class II | Linvatec Corp. dba ConMed Linvatec |
| May 6, 2011 | Pneumatic Systems Operating Manual (part numbers 19-0005) utilized with the P... | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... | Class II | The Anspach Effort, Inc. |
| May 6, 2011 | Cutting Bur Chart (part number 20-0019) utilized with the Electric and Pneuma... | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... | Class II | The Anspach Effort, Inc. |
| May 6, 2011 | Product Catalog (part number 20-0020) utilized with the Electric and Pneumati... | Anspach Effort, Inc. Palm Beach Gardens, FL initiated a correction of its medical Device labeling... | Class II | The Anspach Effort, 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.