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 M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the… The plastic housing on the device may fracture Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedMay 17, 2023ClassClass IIStatusTerminatedWhereNationwide, and Florida, Georgia and Massachusetts named
- Medical device recall PDS¿ Plus Antibacterial (polydioxanone) Suture - PDS PLUS CLR 27IN(70CM) USP3-0(M2) S/A PC-25 PRIME Suture breakage during intra-operative use could result in poor performance of the impacted product because the intended benefit of tissue approximation and/or… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall BioPlex 2200 APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results. Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 28 states named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Connecticut, Florida, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Missouri, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oklahoma, Puerto Rico, South Carolina, Tennessee, Texas, Utah and Vermont named
- Medical device recall TDHisto/Cyto - A software product used for managing medical information in the field of laboratories… In a specific use case, when printing labels for slides, some labels may display wrong information Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Distractor Rack Two lots of the 5598007 Distractor Rack which were not manufactured to specification. Class IIFDA’s classMay 17, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedMay 17, 2023ClassClass IIStatusOngoingWhereConnecticut, Indiana and Nebraska
- Medical device recall STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers… An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Minnesota, Nebraska, Texas and Wisconsin named
- Medical device recall STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612 An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Minnesota, Nebraska, Texas and Wisconsin named
- Medical device recall STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612 An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Illinois, Massachusetts, Minnesota, Nebraska, Texas and Wisconsin named
- Medical device recall COBRA-OS, custom Sheath Introducer Kit, 4 French Custom sheath Introducer contains incorrect needle size Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportMinnesotathe one state its words name PublishedMay 17, 2023ClassClass IIStatusOngoingWhereMinnesota
- Medical device recall BD Pyxis MedStation ES (Med ES Main) Automated dispensing cabinet software is experiencing: 1) ES device download failure resulting in partial patient information loss that leads to 2) partial… Class IIFDA’s classMay 17, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 17, 2023ClassClass IIStatusOngoingWhereNationwide, and Kansas, Louisiana, Massachusetts, Michigan, North Carolina and New York named
- Medical device recall OttLite Rechargeable UVC Disinfecting Wand Product allows for the emission of ultraviolet (UV) electronic product radiation in excess of exposure limits recommended by the International Commission on… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers,… Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables… Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Philips ProxiDiagnost N90 1.0 (Model 706100) and ProxiDiagnost N90 1.1 (Model 706110)- A multi-functional… Potential table stop due to a broken tabletop cable: On the ProxiDiagnost N90 table there is a cable located under the tabletop that is covered by a plastic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall injeTAK Adjustable Tip Needles Needle Sheath diameter 6Fr with 35-50cm in length Stainless-stell needle… The packaging may be damaged, compromising the sterile barrier. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hill-Rom pro+ mattress There is a potential for mattress cover damage (delamination) which may result in fluid absorption in the mattress (fluid ingress). Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CryoTreQ- Aa disposable handheld instrument intended for ophthalmic surgery Device suddenly and forcefully disassembled after cryotherapy, potential for long-term or permanent impairment of a patient or user if a CryoTreq device… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ARTIS pheno systems with a Siemens Healthineers table or Trumpf/MAQUET table (OEM)- Angiography systems… If, during the procedure, X-ray has been released and a reference image has been stored, the following issue may occur: If “Adjust C-arm to Ref” is activated… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall WALGREENS BANDAGES The adhesive bandage contains 0.1% benzalkonium chloride impregnated in the pad and is not disclosed on the labeling. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and California, Connecticut, Florida, Illinois, Ohio, South Carolina, Texas and Wisconsin named
- Medical device recall Centricity PACS-IW with Universal Viewer GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centricity Universal Viewer, Centricity Universal Viewer 6.0 GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) 2049587-011, e)… GE HealthCare has become aware of an issue where information from two different patients can be mismatched when correcting patient or study information. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ultraview SL (UVSL) Command Module Command modules will display the following when parameter processing is suspended, depending on software version: 1) Older versions will have waveforms present… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, 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, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number… There is a negative bias with urine patient samples and urine cortisol Quality Control (QC) results intermittently out of range low. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide
- Medical device recall DERMLITE DL4W Incorrect labeling; Package labeling contains a different serial number then the serial number on the product labeling. Class IIFDA’s classMay 10, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Florida, Iowa, Missouri, Nebraska and Texas named
- Medical device recall LINK SLED Knee System: ENDO SLED KNEE FEM COMP, SMALL Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM SMALL Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ENDO SLED KNEE FEM COMP, MEDIUM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ENDO SLED KNEE FEM COMP, Large Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 45MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 45MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 45MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 45MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 50MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 50MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 50MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 50MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 55MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9MM X 55MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11MM X 55MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13MM X 55MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 7MM X 58MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 9X58MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 11X58MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ALL POLY TIBIAL COMPONENT 13X58MM Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
- Medical device recall LINK SLED Knee System: ENDO Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic… Class IIFDA’s classMay 10, 2023in FDA’s Enforcement Report2 statesnamed in where it went PublishedMay 10, 2023ClassClass IIStatusOngoingWhereNevada and New York
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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