Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Convatec, EsteemBody Drainable Pouch Drainable large pouch may leak due to manufacturing issue. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convatec, EsteemBody Drainable Pouch Drainable large pouch may leak due to manufacturing issue. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Convatec, EsteemBody Drainable Pouch Drainable large pouch may leak due to manufacturing issue. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Due to product exhibiting potential to generate either invalid or false negative results. Class IIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedMar 25, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Iowa, Illinois, Missouri, North Carolina, New Mexico, Puerto Rico and Tennessee named
- Medical device recall Battery Charging Station The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate… Class IIIFDA’s classMar 25, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 11 states named PublishedMar 25, 2026ClassClass IIIStatusOngoingWhereNationwide, and District of Columbia, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, North Carolina, Texas, Washington and Wisconsin named
- Medical device recall MEDLINE UNNA-Z STRETCH ZINC PASTE BANDAGE Due to labeling error. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportIllinoisthe one state its words name PublishedMar 18, 2026ClassClass IIStatusOngoingWhereIllinois
- Medical device recall 10mL Non-Sterile BD Luer-Lok Tip Syringe Only During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Texas named
- Medical device recall IBA Proton Therapy System - PROTEUS 235 It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Florida named
- Medical device recall Raz-AT (Attendant Tilt) Mobile Shower Commode Chair Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and Colorado, Florida, Illinois, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nebraska, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, Texas, Washington and Wisconsin named
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Penner Pacific Bathing Spa The device does not bear a unique device identifier. Class IIIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Impactor handle may be missing cross-pin Class IIFDA’s classMar 18, 2026in FDA’s Enforcement Report25 statesnamed in where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Impactor handle may be missing cross-pin Class IIFDA’s classMar 18, 2026in FDA’s Enforcement Report25 statesnamed in where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Nevada, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Virginia and Wisconsin
- Medical device recall Endo-Model SL Connection Component incl The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model SL Connection Component incl The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model SL Connection Component incl The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall Endo-Model Replacement Plateau The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide, and New Jersey named
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 PAK Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall GEM Premier 5000 Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution… Class IIFDA’s classMar 18, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 18, 2026ClassClass 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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