Browse Device Recalls
26 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 26 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 26 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 9, 2019 | Implant Direct, REF: 833708, Legacy 2 Implant, Surface: HA, 3.7mmD x 8mmL, 3.... | A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the... | 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 |
| Oct 26, 2018 | Implant Direct, REF654311U, simply InterActive Implant, Surface: SBM, Qty 1, ... | packaging error; An internal QA inspection revealed that a incorrect healing collar could have ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Sep 6, 2018 | Implant Direct Scan Adapter Assembly Replant platform for the following part ... | The action is being initiated due to incorrect assembly of the scan adapter . The result of the i... | 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 |
| May 29, 2018 | Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile, 3.5mmD Pl... | Cap may be mislabeled with incorrect part number, although the correct part number is on the main... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 18, 2018 | REPLANT 5.0mmD ABUTMENT, Part number 6050-52-60 | Due to out of specification, the clinician would not be able to fit and engage the abutment with ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 14, 2018 | ImplantDirect simply InterActive Implant, 5.0mmD X 10mmL, SBM: 3.4mmD Platfor... | The cap on the vial might be labeled with the incorrect part number but the main vial label is co... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 23, 2018 | Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0m... | InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 19, 2018 | SwishTapered Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jan 19, 2018 | SwishPlus Implant Intended for use in support for fixed bridgework. | The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been package... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 15, 2017 | Spectra System/Legacy Guided Surgery Handle Kit (Part Number: G-HK) Spect... | The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Im... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Oct 10, 2017 | ImplantDirect Legacy(TM) 3 Implant, 13MM L, REF 864713 This Legacy implan... | One reported complaint and discovered that the outer vial was out of round and undersized. There... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jul 21, 2017 | Implant Direct Swish Duo-Grip Healing Collar, Length: 3mm, Platform: 4.8 mm, ... | The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jun 26, 2017 | Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D24588... | The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the speci... | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 2, 2017 | Legacy Full Contour Laboratory Abutment: 3.5mmD Platform/5.5mmD | Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 3, 2017 | ImplantDirect, Dental implants intended for use in partially and fully edentu... | The main vial label lists the incorrect part number, but the cap label is correct. | Class II | Implant Direct Sybron Manufacturing, LLC |
| Dec 12, 2016 | SwishTapered Implant | The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; L... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 28, 2016 | GoDirect Screw-Retaining Top Part Numbers: 4500-61 | Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDi... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Nov 15, 2016 | ImplantDirect Legacy 4 Implant, 5.7mmD x 5.7mmD Platform, Part 885708, Rx, St... | The vial cap was mislabeled with the incorrect part number of 855708 but the product description ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Jul 5, 2016 | RePlant¿ Angled Abutment Part Number 6050-52-60 | Issue with design specification; oversized condition. | Class II | Implant Direct Sybron Manufacturing, LLC |
| May 19, 2016 | 6534-08N InterActive¿ Implant Open-Tray Transfer Narrow Part Number: 6534-08... | The incorrect sized product, InterActive Implant Open-Tray Transfer Wide, 6534-08W, was packaged ... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Mar 4, 2016 | The Spectra-System Dental Implant 2008 system is comprised of dental implant ... | Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees d... | Class II | Implant Direct Sybron Manufacturing, LLC |
| Oct 28, 2015 | DGDE, DirectGuide Drill Extender. Instrument for use with dental implants. ... | Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender ... | 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.