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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.

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DateProductReasonClassFirm
Oct 2, 2018 Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are... Laser engraved label does not match with the item in the package Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number ... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article N... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Numbe... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article N... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Numbe... A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Mar 23, 2018 Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 A change regarding the shelf life of a raw material was implemented without an appropriate submis... Class II Straumann Manufacturing, Inc.
Nov 23, 2016 Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant ac... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Nov 23, 2016 Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant ... Drills cannot be inserted into handpiece due to tolerance specification not met Class II Straumann Manufacturing, Inc.
Jul 14, 2016 Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number... Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... Class II Straumann Manufacturing, Inc.
Jul 14, 2016 Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Numbe... Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incor... Class II Straumann Manufacturing, 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.