Browse Device Recalls

360 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 360 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 360 FDA device recalls.

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DateProductReasonClassFirm
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM, 32CM, R... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH GRASPERS CROCODILE GRASPER, DOUBLE ACTI 5MM,... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM, 32CM, RATCHETE... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
Jul 13, 2023 Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM, 32CM, RATCHETED,... Specific lots of the product have the potential to exhibit cracking or breaking of the rotation k... Class II Carefusion 2200 Inc
May 22, 2023 BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CI... Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may presen... Class II CareFusion 303, Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; BD Pyxis MedStation ES (Med E... Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in... Class II CareFusion 303, Inc.
Apr 5, 2023 BD Pyxis MedStation ES (Med ES Main), REF: 323; and BD Pyxis MedStation ES ... Due to an automated dispensing cabinet software issue, when a medication single order contains mo... Class II CareFusion 303, Inc.
Mar 16, 2023 (1) Carefusion V. Mueller Graves Vaginal Speculum, Catalog #GL11, Medium Blad... A portion of the two products were incorrectly marked (etched) and packaged resulting in a produc... Class II Carefusion 2200 Inc
Feb 14, 2023 BD Pyxis MedStation ES AUX, REF 324 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis MedStation 4000 AUX, REF 306 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis MedStation ES (Med ES Main), REF 323 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis MedStation 4000 Main, REF 303 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX To... Due to an increase in complaints of door latch assembly failures that may cause the doors to be l... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis Anesthesia ES System (PAS ES), REF: 327; BP Pyxis MedStation ES (Med... Automated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis Med 4000 Auxiliary (AUX), REF 314 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Feb 14, 2023 BD Pyxis Med ES Auxiliary (AUX), REF 343 Drawer and/or door failures that may lead to a delay in access to medications. The following thre... Class II CareFusion 303, Inc.
Jan 30, 2023 CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog ... Product did not meet shelf-life testing requirements resulting in a breach of the sterility of th... Class II Carefusion 2200 Inc
Jan 24, 2023 Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network car... Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless con... Class II CareFusion 303, Inc.
Dec 12, 2022 BD Pyxis MedBank System - Product Label/labeling pending Due to customer complaints related to the MedBank software which may indicate that a different me... Class II CareFusion 303, Inc.
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TI... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS, 1.0MM TIP OVERALL... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller Neuro/Spine TITANUIM BIPOLAR FORCEPS STRAIGHT, 0.25MM T... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED S... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller Neuro/Spine TITANIUM BAYONET INSULATED IRRIGATING BIPOL... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM BAYONET BIPOLAR FORCEPS, 1.5MM TIP, STRAIGHT S... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BAYONET IRRIGATING BIPOLAR FORCEPS 1.0MM TIP OVE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller HARDY BAYONET BIPOLAR FORCEPS WITH STOP, 0.5MM TIP OVER... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller JEWELERS BIPOLAR FORCEPS 0.4MM TIP, STRAIGHT OVERALL LE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller" SCOVILLE-GREENWOOD BAYONET BIPOLAR FORCEPS 1.5MM TIP I... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller CUSHING BAYONET BIPOLAR INSULATED FORCEPS, 0.7MM TIP O... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED IRR... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS,1.0MM TIP... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller SCOVILLE-GREENWOOD BAYONET IRRIGATING BIPOLAR FORCEPS I... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 0.7MM TIP OVERALL ... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM BAYONET INSULATED IRRIGATING BIPOLAR FORCEPS 1... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller" SEMKIN BIPOLAR FORCEPS WITH STOP, 0.7MM TIP OVERALL LE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, OVERALL LENGT... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller CUSHING MICRO BIPOLAR FORCEPS 0.7MM TIP, OVERALL LENGTH... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller CUSHING BAYONET BIPOLAR FORCEPS, 0.7MM TIP, INSULATED I... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller CUSHING BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS 1.5MM TIP OVERALL ... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BAYONET BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller HARDY BAYONET IRRIGATING BIPOLAR FORCEPS INSULATED, 0.5... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller SEMKIN BIPOLAR FORCEPS 1.5MM TIP, INSULATED OVERALL LEN... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller ADSON BIPOLAR FORCEPS 1.0MM TIP, INSULATED OVERALL LENG... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS, 0.7MM TI... XXX Class II Carefusion 2200 Inc
Nov 2, 2022 CareFusion V. Mueller Neuro/Spine TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCE... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 Inc
Nov 2, 2022 Carefusion V. Mueller GERALD BIPOLAR FORCEPS 1.0MM WIDE TIP OVERALL LENGTH 7"... BD has determined that the Instructions For Use (IFU) provided by BD is missing certain content t... Class II Carefusion 2200 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.