Medical devices, 2023
Shortlist up to four to read them side by side.
2,477 medical device recalls FDA’s Enforcement Report published in 2023, 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.
2,477of 2,477 medical device recallsshown with your filters
The list
- Medical device recall Medline Sterile Oncology Port Access Tray The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Colorado and Georgia named
- Medical device recall (1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep… The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Colorado and Georgia named
- Medical device recall (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL… The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide, and Arkansas, Colorado and Georgia named
- Medical device recall Luminos Agile with software VC10 - A diagnostic imaging system for radiographic and fluoroscopic studies Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminos Agile Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic… Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminos dRF with software VD10- A diagnostic imaging system for radiographic and fluoroscopic studies Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Luminos dRF Max with software VE10, VF10, VF11- A diagnostic imaging system for radiographic and fluoroscopic… Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Uroskop Omnia Max with software VE10 & VF11- A diagnostic imaging system for radiographic and fluoroscopic… Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of… Class IIFDA’s classMar 1, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 1, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall EVOLUTION MP Tibial Bases, Size 2+ LEFT One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 22, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall EVOLUTION MP Tibial Bases, Size 7 LEFT One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 22, 2023ClassClass IIStatusTerminatedWhereNo state named
- Medical device recall Orthex Large Bone Shoulder Bolt Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE ANGIO PORT KIT W/HIGH GRADE IN, Reorder Number DYNDC2691 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE PERF The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE CABG PACK, Reorder Number DYNDA2827 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS NEONATAL PICC TRAY, Reorder Number CVI4685 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE PLASTICS/PEDS KIT, Reorder Number DYNDA2489 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS L & D TRAY, Reorder Number MNS9065 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: a) MEDLINE GENERAL UTILITY, Reorder Number DYNDA2524 b) CENTURION… The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CHEST TUBE INSERTION TRAY, Reorder Number… The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: a) MEDLINE PERF The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE SHOULDER SUSPENSION I-LF, Reorder Number DYNJSHOULDER The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder… The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS IR INSTRUMENT TRAY, Reorder Number SUT10675 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS CIRCUMCISION TRAY, Reorder Number CIT3345 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical convenience kits labeled as: a) MEDLINE HAND PACK, Reorder Number DYNJ67850 The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HydroMID 4Fr Single Lumen - Basic Kit Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee and Texas named
- Medical device recall HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee and Texas named
- Medical device recall HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Connecticut, Illinois, Indiana, Massachusetts, Nebraska, Tennessee and Texas named
- Medical device recall EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract… A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in… Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, New York, Oregon and Virginia named
- Medical device recall iTotal Identity Impactor Handle Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 19 states named PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, Colorado, Florida, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Mississippi, Nebraska, New Hampshire, Nevada, New York, Ohio, Tennessee, Wisconsin and Wyoming named
- Medical device recall SIEMENS Biograph Horizon 3R Mobile This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic,… This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIEMENS Biograph Vision: a) 450, b) 600, c) 600 Edge This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position. Class IIFDA’s classFeb 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 22, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NuVasive MD Pulse III Multimodality System Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper… Class IIIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedFeb 15, 2023ClassClass IIIStatusOngoingWhereNationwide, and California, Florida, North Carolina, Ohio and Texas named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) 870, b) 870 DR 3/8 inch NM GANTRY WITH NEW ROTOR… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) 830, b) 830 / Dismount, c) 830 /, d) 830 /… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) BRIVO B615 3/8 inch DHP BJG NR, b) BRIVO 615 3/8… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) OPTIMA O640 X 3/8 inch NR, b) DISCOVERY O640 X… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) 870 CZT O540+ Gantry 7.25mm, b) D670 CZT Gantry… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM… A mitigation may not be correctly implemented. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 15, 2023ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall FLUIDSHIELD 3 Fog-Free Procedure Mask with SO SOFT Lining and SO SOFT Earloops, Orange, WrapAround Visor Face masks were placed into the incorrect dispenser boxes. Class IIIFDA’s classFeb 15, 2023in FDA’s Enforcement Report5 statesnamed in where it went PublishedFeb 15, 2023ClassClass IIIStatusOngoingWhereIllinois, North Carolina, New York, Ohio and Pennsylvania
- Medical device recall ANCILLARY PACK-LF Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging. Class IIFDA’s classFeb 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 15, 2023ClassClass 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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