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 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Currently labeled shelf life of 36 months is not substantiated by real-time data. Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, New Jersey, Ohio and Pennsylvania named
- Medical device recall Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Indiana, Kentucky, Missouri, New York, Ohio and Washington named
- Medical device recall Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the Large… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, Florida, Indiana, Kentucky, Missouri, New York, Ohio and Washington named
- Medical device recall Neuroguard IEP 3 Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter, that due to a wire-to-filter-bond issue, may… Class IIFDA’s classAug 12, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedAug 12, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Delaware, Florida, Illinois, Indiana, Kentucky, Michigan, North Carolina, New Jersey, Pennsylvania, Virginia and Wisconsin named
- Medical device recall Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64… The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall IQon Spectral CT IQon Spectral CT Upgrades The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades… The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent… Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and interruption of… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedAug 5, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Power Over Fiber Base Module Device not certified - no laser product report was filed with CDRH prior to distribution. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Pack Angiography NCMC 3/Cs BANNER Cardiovascular procedure kits contain manifolds, the subject of another recall, that may have particulate within the fluid path, which has the potential to be… FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 5, 2026in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 5, 2026ClassClass IStatusOngoingWhereArizona and Colorado
- Medical device recall Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock This recall has been reported retroactively. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206 The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 14 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Connecticut, Georgia, Illinois, Massachusetts, Maryland, New York, Ohio, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may… Class IIFDA’s classAug 5, 2026in FDA’s Enforcement Report28 statesnamed in where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall L-Cath Midline S/L Catheter 20ga Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may… Class IIFDA’s classAug 5, 2026in FDA’s Enforcement Report28 statesnamed in where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereArkansas, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, North Carolina, North Dakota, New Jersey, Nevada, New York, Oregon, Tennessee, Texas, Utah, Virginia and Washington
- Medical device recall M5 Corpus Power Wheelchair REF,120032 This recall is being reported retroactively. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 39 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an… Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an… Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an… Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an… Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return… Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 22 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, New Hampshire, New Jersey, Nevada, New York, Oregon, Pennsylvania, Texas, Virginia and Washington named
- Medical device recall OsteoBallast, 45 x 17.5 mm (SeaSpine Brand) Demineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis, were… Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Arkansas, California, New Jersey, Ohio, Tennessee and Washington named
- Medical device recall GEM Premier 5000 with IQM2 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GEM Premier 7000 with iQM3 Product Name: GEM Premier 7000 with iQM3 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: GEM Premier 5000 Product Name: GEM Premier 5000 Potential for Bar Code Reader (BCR) wands, used with the GEM Premier 5000 and GEM Premier 7000 systems, to assign patient results to an incorrect patient ID. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 30mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 40mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 50mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 60mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 90mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 120mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall Stryker Hoffmann II Connecting Rod Micro 3 x 150mm Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Class IIFDA’s classAug 5, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 31 states named PublishedAug 5, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Idaho, Illinois, Kansas, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Wisconsin and West Virginia named
- Medical device recall The intended use is to be paired with a weapon for aiming purposes. Wilcox is notifying all customers who have purchased a product from the BOSS Xe family that a software enhancement to increase safety has been released and all… Class IIFDA’s classJul 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 29, 2026ClassClass IIStatusOngoingWhereNationwide, and New Hampshire named
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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