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.

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DateProductReasonClassFirm
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.