Browse Device Recalls

35,290 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 35,290 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 35,290 FDA device recalls, Class II.

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DateProductReasonClassFirm
Oct 2, 2024 Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... The door on the Spectrum IQ Infusion pump may not be able to fully close. Class II Baxter Healthcare Corporation
Oct 2, 2024 smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 L... Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant inst... Class II Smith & Nephew Inc
Oct 1, 2024 McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for ... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Oct 1, 2024 MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLIN... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Oct 1, 2024 Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate... Due to defects on primary packaging pouch that compromise the device's ability to maintain a ster... Class II Advanced Medical Solutions Ltd.
Sep 30, 2024 IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog... The IMMULITE 2000 PSA assay for use on the IMMULITE 2000 and IMMULITE 2000 XPi analyzers did not ... Class II Siemens Healthcare Diagnostics, Inc.
Sep 30, 2024 Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 1... Disposable biopsy instruments were potentially manufactured missing the backend notch retention f... Class II Bard Peripheral Vascular Inc
Sep 30, 2024 The Access Cortisol assay is a paramagnetic particle, chemiluminescent immun... The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance p... Class II Beckman Coulter, Inc.
Sep 30, 2024 Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straig... Due to potential issues with design, manufacturing and documentation issues related to the valida... Class II NuVasive Specialized Orthopedics, Inc.
Sep 27, 2024 AVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a batter... Values used to calibrate whole blood oximeter instruments were observed to be higher than normal,... Class II Accriva Diagnostics, Inc.
Sep 27, 2024 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5... Due to connector within the circuit flex extender not meeting specifications resulting in a low c... Class II Westmed, Inc.
Sep 26, 2024 Duraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694 Out of specification endotoxin levels. Class II Integra LifeSciences Corp.
Sep 26, 2024 KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s ph... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
Sep 26, 2024 KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx thr... Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new in... Class II King Systems Corp. dba Ambu, Inc.
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 25, 2024 intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buff... Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohi... Class II Biocare Medical, LLC
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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.

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.