Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Jul 1, 2024 Cobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubb... mislabeling; EMG RLN monitoring kit labeling contains the incorrect tube size. Class II Neurovision Medical Products Inc
Jul 1, 2024 The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm ... Fractures and breakages in packaging trays and Tyvek covers, which may result in a sterility breach Class II Olympus Corporation of the Americas
Jun 28, 2024 IntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x enti... Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... Class II Philips North America Llc
Jun 28, 2024 IntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x ent... Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... Class II Philips North America Llc
Jun 28, 2024 Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300 Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the PST 500 U Pr... Class II Baxter Healthcare Corporation
Jun 28, 2024 IntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x enti... Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... Class II Philips North America Llc
Jun 28, 2024 IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x enti... Philips lntelliVue Patient Monitors MX400/450/500/550 Shipped or Upgraded with Incorrect Software... Class II Philips North America Llc
Jun 27, 2024 Capio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Sut... Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... Class II Boston Scientific Corporation
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVD Their is a potential for high background and off-target staining when using the monoclonal primar... Class II Ventana Medical Systems, Inc.
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION ... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Capio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261,... Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting ... Class II Boston Scientific Corporation
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Arctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT, NA/60... If temperature management system fails to reach correct target water temperature while device is ... Class II Medivance Inc.
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 27, 2024 LINK SymphoKnee Patella Sizing Template, Item Number 881-509/00 The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of t... Class II LINK BIO CORP
Jun 27, 2024 Medline convenience kits containing semi-rigid suction liners labeled as foll... XXX Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, Product Code 21-7001-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD 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.
Jun 26, 2024 smiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model... The adapter input plug can become damaged or broken. If the input plug is damaged, the metal con... Class II Smiths Medical ASD, Inc.
Jun 26, 2024 ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code... Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number... The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 ENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28 Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JP Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medicat... Class II Smiths Medical ASD Inc.
Jun 26, 2024 DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 25, 2024 1. Tech Medical Services Inc. Detachable Endo Retrieval Pouch, REF TM2001, 3... The tube may fall into the surgical site during the grasping process. Class II UNIMAX MEDICAL SYSTEMS INC
Jun 25, 2024 HeartMate 3 System Controllers provided within the following HeartMate 3 Left... Left ventricular assist system controller UI membrane/screen may lift along the edge of the contr... Class II Thoratec LLC
Jun 25, 2024 Multiple Digital Analog Products labeled as: NobelBiocare Tri-Lobe-compatibl... Due to a manufacturing issue, the product has a out of specification rotation of the digital anal... Class II Preat Corp
Jun 24, 2024 BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version... Due to software issue, there is a potential when a restock label is printed for a medication stor... Class II CareFusion 303, 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.