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Browse Device Recalls

16 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 16 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 16 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 17, 2020 SnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot... The action is being taken due to an increase in complaints relating to the lower buccal tube slid... Class II Ormco/Sybronendo
Jan 17, 2020 SnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot... The action is being taken due to an increase in complaints relating to the lower buccal tube slid... Class II Ormco/Sybronendo
Jan 14, 2020 Ormco Damon Q2 Orthodontic Metal Bracket, Part No. 491-9834, L3R Hi Tq Hook, ... The bracket torque was mislabeled on the packaging. Class II Ormco/Sybronendo
Dec 27, 2017 Elements Obturation Unit (EOU) used with respective Buchanan Heat Pluggers ... Buchanan Heat Pluggers will possibly overheat while used with the Elements Obturation Unit (EOU). Class II Ormco/Sybronendo
Aug 31, 2016 Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex X... SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration d... Class II Ormco/Sybronendo
Feb 8, 2016 TF Adaptive Gutta Percha Point Size SM3 50pk, Part No. 815-1541 Intended t... Ormco Corporation is recalling the TF Adaptive Gutta Percha Point Size SM3-50pk because the inner... Class II Ormco/Sybronendo
Nov 4, 2015 Copper NiTi Preformed Archwires; Copper NiTi 40 BAF .016X.022 LO Pk10, Part N... Ormco Corporation is recalling Copper NiTi Preformed Archwires because the product transformation... Class II Ormco/Sybronendo
Mar 25, 2014 Titanium Orthos Brackets, an orthodontic bracket. 022 +9/+9/0, Part Number 4... Ormco Corporation inititated recall of U2R Titanium Orthos (0.22+9/+9/0), Part Number 449-6212, L... Class II Ormco/Sybronendo
Mar 25, 2014 Spirit MB Bracket, UR Central +14T +5A.018, Part Number 494-0110, Lot Number ... Ormco Corporation initiated this recall of Spirit MB Brackets, Part Number 494-0110, Lot Number 0... Class II Ormco/Sybronendo
Jul 12, 2013 Brand Name: Vector TAS 8mm Screw. The Device Listing Number is E670535. ... Ormco Corporation is voluntarily recalling one lot of 8 MM Vector TAS Screws because some screws ... Class II Ormco/Sybronendo
Mar 8, 2013 Bracket Buccal Tube U7L DB/UL22 Roth MT HK 0/-14/0 Product Usage: Bra... Ormco Corporation is voluntarily recalling one (1) lot of Bracket Buccal Tubes as a result of a p... Class II Ormco/Sybronendo
Jan 17, 2013 SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; Sybr... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Jan 17, 2013 SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; ... A recall has been issued by SybronEndo because a Canadian Standards Association (CSA)-directed ca... Class II Ormco/Sybronendo
Dec 12, 2012 Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 2... The length markings on the Lightspeed LSX files were wrong. Class II Ormco/Sybronendo
Apr 24, 2012 The brand name of the device is Damon 3MX Bicuspid Bracket, an orthodontic br... The firm initiated the recall as a result of a misidentification of the brackets. Damon 3MX Bicus... Class III Ormco/Sybronendo
Dec 12, 2011 Vector TAS Modular Driver, a manual driver for Vector TAS dental screws. The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections ... Class II Ormco/Sybronendo

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.