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Browse Device Recalls

5 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5 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 5 FDA device recalls.

Clear
DateProductReasonClassFirm
Jan 5, 2016 T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single pat... Reports that the T-piece does not fit on the nebulizer. Class II Salter Labs
Aug 4, 2015 NebuTech Nebulizer, Model number: Series 8660, 8960, 8961, 8966, 8984. Nebuli... The Inspiratory valve cap on the nebulizer reservoir tower may be loose and may detach before or ... Class II Salter Labs
Jun 25, 2014 Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentrat... The case label correctly states partial rebreather but the insert label incorrectly states non-re... Class II Salter Labs
Nov 1, 2013 Salter Labs EtCO2 Sample line 15' (4.6 M) tube, male luer connectors. Rx onl... It has been determined that three lots of model number 4515-15-25 CO2 Sample Line 15' tube, male ... Class II SALTER LABS
May 30, 2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 f... A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock... Class II SALTER LABS

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.