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Browse Device Recalls

214 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 214 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 214 FDA device recalls.

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DateProductReasonClassFirm
Dec 4, 2024 Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of... Incorrect catheter connector within the kit resulting in inability to provide a secure connection... Class II B. Braun Medical, Inc.
Aug 8, 2024 AET36 ANESTH EXT SET - Anesthesia Extension Set - Normally Closed Dual Manifo... Potential for product leakage from the Spin Lock Connector on the distal end of the device due to... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-power... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK IV SET 15DROP W/3 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/2 CARESITE CV- Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2 FIL, 2 CRSITE-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 90 IN. Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered ... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electricall... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powere... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-po... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/ 3 ULTRASITE LL-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infu... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infus... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE-Used with an electrically-pow... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-p... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jun 17, 2024 OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered in... Potential for the backcheck valve to malfunction, resulting in backflow of medication from second... Class II B. Braun Medical, Inc.
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter ... Class II B. Braun Medical, Inc.
Jan 22, 2024 Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter... Class II B. Braun Medical, Inc.
Nov 1, 2023 Infusomat Administration Sets as listed below: 362031 Infusomat Space Pu... In affected products, the tubing outer diameter may vary in size or the length of tubing may be t... Class I B. Braun Medical, Inc.
Sep 26, 2023 BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration com... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 FT1000S FLUID TRANSFER SET, REF No. 356048. For direct transfer of fluids bet... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation. Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast manageme... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 THERASPHERE ADMIN SET, Article No. 7M2650. Canada only. Sterile, single use ... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 26, 2023 TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070. Singapore only.... Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, ... Class II B. Braun Medical, Inc.
Sep 21, 2023 8713052U, Infusomat Large Volume Pump, Non-Wireless BATTERY PACK; Volumetric ... Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Sep 21, 2023 8713051U, Infusomat Large Volume Pump, Wireless; Volumetric Infusion Pump System Upstream occlusion alarm may sound when no occlusion exists, and the device will stop pumping. In... Class I B. Braun Medical, Inc.
Aug 7, 2023 B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... The sterile blister packaging may be damaged, and sterility may be compromised Class II B. Braun Medical, Inc.
Aug 7, 2023 B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... The sterile blister packaging may be damaged, and sterility may be compromised Class II B. Braun Medical, Inc.
Jul 31, 2023 Perifix¿ / Epidural anesthesia set, medicated Product may be mislabeled with an incorrect lid stock label. Class II B. Braun Medical, Inc.
Jun 5, 2023 Perifix¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 5, 2023 Design Options¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II 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.