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Browse Device Recalls

66 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 66 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 66 FDA device recalls.

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DateProductReasonClassFirm
Mar 9, 2015 NobelReplace CC RP 4.3x11.5mm, Article No. 36707. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC RP 5.0x10mm, Article No. 36711. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NOBELREPLACE Tapered Groovy 6.0 6x8mm, Article No. 32223. Nobel Biocare's De... A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC RP 4.3x10mm, Article No. 36705. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC PMC RP 5.0x10mm, Article No. 37296. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 Replace Select Tapered TiU NP 3.5x11.5mm, Article No. 36105. Nobel Biocare's... A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC NP 3.5x11.5mm, Article No. 36701. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC NP 3.5x13mm, Article No. 36702. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC RP 4.3x8mm, Article No. 36704. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC PMC RP 4.3x8mm, Article No. 37290. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NOBELREPLACE Tapered Groovy RP 4.3x10mm, Article No. 32216. Nobel Biocare's ... A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC PMC NP 3.5x13mm, Article No. 37288. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC NP 3.5x10mm, Article No. 36700. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Mar 9, 2015 NobelReplace CC PMC RP 5.0x13mm, Article No. 37298. A material used in the packaging of the dental implants may impart a sticky substance on the top ... Class II Nobel Biocare Usa Llc
Oct 24, 2013 Osseocare Pro Console & Set Osseocare Pro, Model 1600870-001, 1700470-001, an... The recall was initiated because there is a potential for malfunction of the OsseoCare Pro when u... Class II Nobel Biocare Usa Llc

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.