Browse Device Recalls

180 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 180 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 180 FDA device recalls.

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DateProductReasonClassFirm
Jul 9, 2025 Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for us... Label is incorrect. The product label indicates that the device contains an air eliminating filte... Class I B BRAUN MEDICAL INC
Feb 17, 2025 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive saf... Increased risk for valve housing detachment causing leakage. Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE BLOODLINE SET FOR DIALOG DR-Tubing to be used to transfer blood be... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE BLOODLINE LONG VERSION, FMC-Tubing to be used to transfer blood be... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE LONG-Tubing to be used to transfer blood between a patient and a h... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE BLOODLINE SET FOR DIALOG-Tubing to be used to transfer blood betwe... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 STREAMLINE FRESENIUS FOR DAVITA-Tubing to be used to transfer blood between a... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Bloo... Class II B Braun Medical Inc
Aug 15, 2024 SL BLOODLINE FOR FMC 2008 SERIES-Tubing to be used to transfer blood between ... Incomplete insertion of the patient connector of the Streamline Airless System Hemodialysis Blood... Class II B Braun Medical Inc
Aug 7, 2024 Infusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to... Class I B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wi... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catal... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Ca... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
Jun 14, 2024 Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wirele... Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an ... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
May 17, 2024 Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... Class II B Braun Medical Inc
Sep 1, 2022 Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive ant... Potential for leakage at the catheter hub. Class II B Braun Medical Inc
Feb 7, 2022 PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be ... Units not properly inspected prior to release to the market, may not function as indicated in the... Class II B Braun Medical Inc
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Jan 28, 2022 Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Co... Firm learned of the potential for cracks to form in the conductivity sensors during use, which ma... Class II B Braun Medical Inc
Apr 10, 2017 CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units eac... B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connector due to a potential f... Class II B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Seria... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The D... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product ... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical Inc
Apr 1, 2016 Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710... Potential leakage of conductivity sensors of the Dialog Dialysis machines. Class I B Braun Medical 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.