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Browse Device Recalls

11 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 11 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 11 FDA device recalls.

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DateProductReasonClassFirm
May 21, 2025 REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood C... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381811, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 G... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 i... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 382944, BD Insyte Autoguard BC Pro Winged Shielded IV Catheter, 18 GA x ... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00 IN (0.9 X... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381433, BD Insyte Autoguard Shielded IV Catheter, 20GA x 1.00 in (1.1x25... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 ... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
May 21, 2025 REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1... Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... Class II Becton Dickinson Infusion Therapy Systems, Inc.
Apr 21, 2025 BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: ... Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in bloo... Class II Becton Dickinson Infusion Therapy Systems, Inc.
Jun 26, 2024 BD Insyte Autoguard BC, Shielded IV Catheter with Blood Control Technology, R... Catheters may contain a hole in the catheter tubing, which could result in leakage during the ins... Class II Becton Dickinson Infusion Therapy Systems, 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.