Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Baxter TruSystem 7500 Hybrid (FC) There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 Hybrid (SC) There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 Hybrid Plus (FC) There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 Hybrid Plus (SC) There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 Hybrid MR IMRIS There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter TruSystem 7500 There is a software issue which causes the upper back section to not be operable/adjustable when the “emergency mode” function is enabled. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Baxter NovumIQ Syringe INFUSION SYSTEM Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe pumps listed below due to an incorrectly installed gasket. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Iowa, Indiana, Louisiana, Missouri, Montana, North Carolina, New York, Ohio, Oregon, Pennsylvania, Tennessee, Texas, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Brand Name: Banner Health Systems Product Name: Cysto Pack Sterility assurance with procedure trays Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportArizonathe one state its words name PublishedApr 2, 2025ClassClass IIStatusOngoingWhereArizona
- Medical device recall Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Sterility assurance with procedure trays Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportArizonathe one state its words name PublishedApr 2, 2025ClassClass IIStatusOngoingWhereArizona
- Medical device recall Brand Name: Banner University Med Ctr Sterility assurance with procedure trays Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportArizonathe one state its words name PublishedApr 2, 2025ClassClass IIStatusOngoingWhereArizona
- Medical device recall CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Due to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with some… Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 46 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium… The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct… Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado and Missouri named
- Medical device recall NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis The “Use with plate 7, 8, 9, 10” compatibility statement on top of the label does not match with the compatibility statements “USE WITH PLATE 5, 6” in the… Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Kansas, Massachusetts, Maryland, Maine, Nebraska, New Jersey, Oregon, South Dakota and Texas named
- Medical device recall Prelude IDEAL 4 F Hydrophilic Sheath Introducer Hydrophilic Sheath Introducer labeled for 4F dilators may instead incorrectly contain 5F dilators. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJRA0869A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ0826753O Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ61061D Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622 Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS0101I Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number 613034700, 2) C SCOPE DISPOSABLE… Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Helix Elite Inactivated Standard: Inactivated Influenza A/B and Respiratory Syncytial Virus, Multi-analyte,… The RSV target may give a late Ct value and could potentially not pass QC. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Kentucky, Montana, New Jersey, New York and Wisconsin named
- Medical device recall Brand Names: MyDay Toric, LensCrafters One Day Premium Daily Disposable Contact Lenses For Astigmatism,… a limited number of lots were manufactured with an incorrect cylinder power. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement Report15 statesnamed in where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Illinois, Kentucky, Michigan, North Carolina, Nebraska, New Jersey, New York, Ohio, Oregon, Utah, Virginia and Washington
- Medical device recall Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Devices may have higher than expected amounts of bacterial endotoxin. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Arizona, California, Colorado, Iowa, Illinois, Kansas, Oregon, Tennessee, Texas, Washington and Wisconsin named
- Medical device recall Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Number DYNJ37741B Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead,… Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead,… Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated… The air bladders inside the mattress may move out of position when the head of the bed is elevated, causing a dip in the mattress. Class IIFDA’s classApr 2, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 2, 2025ClassClass IIStatusOngoingWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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