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Browse Device Recalls

14 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 14 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 14 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 20, 2023 SciCan STATIS SL S10001 Dental Handpieces-Intended for the removal of carious... Screw connection between the turbine head and the push button may loosen and fall off during the ... Class II Coltene Whaledent Inc
Mar 18, 2021 Dental pins - TMS LINK PLUS Self-Threading Pins - Product Usage: implanted in... The incorrect dental pins were packaged and subsequently distributed. Class II Coltene Whaledent Inc
Oct 20, 2020 Strauss 25 Carbide Dental Burs (100057XXV) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi... Class II Coltene Whaledent Inc
Oct 20, 2020 Clinic Pack 100 Pieces FG 57 100057C (100057C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi... Class II Coltene Whaledent Inc
Oct 20, 2020 Alpen Clinic 100 Carbide Instruments (R100057C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi... Class II Coltene Whaledent Inc
Oct 20, 2020 FG 57 100057X (100057X) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi... Class II Coltene Whaledent Inc
Oct 20, 2020 CEI Cutting Edge Instruments (PTC-57C) The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more materi... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Simple Dam Kit, Model no. 60019066 - Product Usage: The dental dam fo... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Dental Dam Forceps, Model no. H01262 - Product Usage: The dental dam ... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Winged Fiesta Kit, Model no. H02778 - Product Usage: The dental dam f... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Jun 3, 2020 HYGENIC Wingless Fiesta Kit, Model no. H02790 - Product Usage: The dental dam... Multiple Coltene batches of the product have a pin size larger than acceptable, which may make it... Class II Coltene Whaledent Inc
Aug 21, 2018 ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catal... ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 Class II Coltene Whaledent Inc
Apr 13, 2018 Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model ... The products are labeled with an incorrect product number. Class II Coltene Whaledent Inc
Dec 11, 2013 Latex Dental Dams labeled as Non-Latex Dental Dams Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. Dur... Class II Coltene Whaledent 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.