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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Date	Product	Reason	Class	Firm
Sep 25, 2024	Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118...	Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with...	Class I	Cardinal Health 200, LLC
Sep 25, 2024	Coated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Produc...	Complaints were received regarding needle pull-off and suture degradation. Analysis on returned p...	Class II	Ethicon, Inc.
Sep 24, 2024	Quest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-00...	Does not meet the requirements for electromagnetic compatibility (EMC) of the standard IEC 60601-...	Class II	Olympus Corporation of the Americas
Sep 24, 2024	medex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Disposable Transducer 1/EA, Product Code REF MX950	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	Brand Name: Vial2Bag Advanced¿ Product Name: Vial2Bag Advanced¿ 20mm Admixtu...	Due to packaging damage from heat exposure during shipping/transportation that may result in a br...	Class II	West Pharmaceutical Services AZ, Inc.
Sep 24, 2024	medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530T	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Single ICP Set 1/EA, Product Code REF MX20897	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code R...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.	A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able ...	Class II	Medtronic Neuromodulation
Sep 24, 2024	medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515	Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lo...	Class II	Siemens Healthcare Diagnostics Inc
Sep 24, 2024	medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Devi...	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNT	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFT	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	smiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	medex Arterial Kit 1/EA, Product Code REF MX7827	Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interrupti...	Class II	Smiths Medical ASD, Inc.
Sep 24, 2024	REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile	Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend...	Class II	Orthofix Srl
Sep 23, 2024	KLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40),...	The packaging of a sterile battery, intended to power a surgical screwdriver, may contain Tyvek s...	Class II	Pro-Dex Inc
Sep 22, 2024	ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of EL...	Potential challenge with intraoperative assembly of the external taper of a single midsection wit...	Class II	Onkos Surgical, Inc.
Sep 20, 2024	Halyard EP PACK - Medical convenience kits Model Number: VANW018-06	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard LAPAROSCOPY TRAY - Medical convenience kits Model Number: LANC006-25	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard GYN PAC - Medical convenience kits Model Number: SJGY20-02	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	SURG PAT XRAY 1X1 Model/Catalog Number: 801403. The surgical patties and su...	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma...	Class II	Integra LifeSciences Corp.
Sep 20, 2024	Halyard HEART CATH LAB PK, STRL F G - Medical convenience kits Model Number:...	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard C SECTION BUNDLE - Medical convenience kits Model Number: LANC015-34	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard MINOR PDS - Medical convenience kits Model Number: GVVA009-06	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard LINE INSERTION PACK - Medical convenience kits Model Number: MAMC217-18	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN...	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard EP TRAY - Medical convenience kits Model Number: VAST038-04	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	SURG STRP 1/4X6 Model/Catalog Number: 801450. The surgical patties and surg...	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma...	Class II	Integra LifeSciences Corp.
Sep 20, 2024	Halyard PACEMAKER INSTRUMENT PACK - Medical convenience kits Model Number: V...	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	SURG PAT XRAY 1/2X3 Model/Catalog Number: 801407. The surgical patties and ...	Identified higher-than-expected levels of endotoxin within the raw material used to produce Codma...	Class II	Integra LifeSciences Corp.
Sep 20, 2024	Halyard GENERAL SET UP PACK - Medical convenience kits Model Number: ESJH005-02	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID Medical, Inc.
Sep 20, 2024	Halyard MINOR PACK - Medical convenience kits Model Number: MMOK013-03	Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach...	Class II	AVID 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.