Browse Device Recalls

13 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 13 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 13 FDA device recalls.

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DateProductReasonClassFirm
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-500 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-530 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533 used for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-536L used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for corre... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, Inc.
May 1, 2018 Jasper Vektor, Class II Correction Appliance, Part No. 610-527R used for corr... The firm has received 106 complaints of the device breaking in the patient's mouth. Device breaka... Class II TP Orthodontics, 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.