Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 1, 2025 | The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used ... | The Drill stop kit contains incorrect components. | Class II | Implant Direct Sybron Manufacturing LLC |
| May 2, 2023 | LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2M... | Non-engaging abutments were distributed without FDA clearance; the performance characteristics ha... | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Sep 23, 2021 | ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform, | Packaged dental implant contains a different size then the size declared on the labeling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Oct 11, 2019 | Implant Direct, CE 0086, REF: 855710, Legacy 3 Impant, Surface: SBM, Qty:1, S... | Through a customer complaint and and internal investigation it was determined that some implant p... | Class II | Implant Direct Sybron Manufacturing LLC |
| Oct 7, 2019 | Legacy 3 Implant, Size: 4.2mmD x 13mmL, 3.5mmD Platform, REF: 864213 | Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling. | Class II | Implant Direct Sybron Manufacturing LLC |
| Jan 9, 2019 | SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708 | Due to a complaint received and internal investigation it was determined that implant vials were ... | Class II | Implant Direct Sybron Manufacturing LLC |
| Nov 28, 2018 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6534-09PT, Platfor... | The peek part was loose on the titanium base of the device which could result in it falling into ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 28, 2018 | ImplantDirect InterActive Precision IO Scan Adapter, Part #6530-09PT, Platfor... | The peek part was loose on the titanium base of the device which could result in it falling into ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 8, 2018 | ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mm... | Two units in distribution were found to be mislabeled on the vial cap with the incorrect part num... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Aug 7, 2018 | ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, R... | The incorrect device was packaged in the vial. | Class II | Implant Direct Sybron Manufacturing, LLC |
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.