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Browse Device Recalls

8 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 8 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 8 FDA device recalls.

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DateProductReasonClassFirm
Nov 30, 2022 Source Administration Set (SAS) used with the Medrad Intego PET Infusion Syst... Black specks may be present on the packaged needles Class II Bayer Medical Care, Inc.
Sep 14, 2021 The MEDRAD Twist & Go Disposable Syringe 150 mL with Quick Fill Tube is a syr... Labeling error: MEDRAD Mark 7 Arterion Injection System Syringes (ART 700 SYR) labeled as Twist &... Class II Bayer Medical Care, Inc.
Oct 5, 2020 Brand Name: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic Sy... Specific lots of MEDRAD Stellant FLEX 150 mL syringe kits may have holes and/or cracks that have... Class II Bayer Medical Care, Inc.
Dec 14, 2018 MAVIG Portegra or Portegra2 Overhead Counterpoise System (OCS) used in conjun... If the head mount knob is not properly tightened and the operator directly uses the injector head... Class II Bayer Medical Care, Inc.
Sep 7, 2018 Codan Filter (Codan catalog number BC 693) used with Medrad Patient Administr... Bayer has received reports of loose particulate in the filter when the dust cap is removed. Bayer... Class II Bayer Medical Care, Inc.
Jun 28, 2018 Overhead Counterpoise Systems (OCS), OCS CONF,STD CEIL MNT, STD HORZ ARM, Cat... The torque wrench used on the ceiling column assembly during a recent service visit was outside o... Class II Bayer Medical Care, Inc.
Jun 28, 2018 Overhead Counterpoise Systems (OCS), OCS, 580mm CEILING MOUNT, PORTEGRA2, Cat... The torque wrench used on the ceiling column assembly during a recent service visit was outside o... Class II Bayer Medical Care, Inc.
Jun 28, 2018 Overhead Counterpoise Systems (OCS) OCS CONF an accessory device for use with... The torque wrench used on the ceiling column assembly during a recent service visit was outside o... Class II Bayer Medical Care, 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.