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Browse Device Recalls

9 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 9 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 9 FDA device recalls.

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DateProductReasonClassFirm
Apr 13, 2022 AUTOLITH Touch 1.9F 375cm Biliary Electrohydraulic Lithotripter Probe Product labeled incorrectly. Class II Northgate Technologies, Inc.
Oct 25, 2021 Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M... The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low s... Class II Northgate Technologies, Inc.
Jan 15, 2021 ConMed 50L abdominal insufflator, Catalog Number 72-00258-0 / GS2000 - Produc... An internal tubing component in the flow path was made with incorrect material which was not test... Class II Northgate Technologies, Inc.
Jan 15, 2021 Steris CO2MPACT Endoscopic Insufflator system, Catalog Number 72-00310-0 / 71... An internal tubing component in the flow path was made with incorrect material which was not test... Class II Northgate Technologies, Inc.
Mar 10, 2020 ACMI 9FR PROBE (E4-9F) Manufactured for Olympus Surgical Technologies, Americ... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 AUTOLITH URO-TCH 9FR PROBE 54CM; NTI Catalog Number 9-203-0543 - Product Usag... Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing. Class II Northgate Technologies, Inc.
Mar 10, 2020 Probe, 9 FR AUTOLITH; NTI Catalog Number 9-900-54 - Product Usage: Probes are... As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompat... Class II Northgate Technologies, Inc.
May 24, 2017 Electrohydraulic lithotripter probe, 1.9 FR 375 cm, Model 9-195-371DS used wi... The inner and outer labels on the product contain incorrect reference number of 9-202-3751DS. Acc... Class II Northgate Technologies, Inc.
Nov 21, 2016 Insufflator, laparoscopic The ConMed GS2000, Smith & Nephew 500, Novadaq 5... Device could cause a patient overpressure situation without any visual or auditory indication or ... Class II Northgate Technologies, 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.