Medical devices, 2022
Shortlist up to four to read them side by side.
2,192 medical device recalls FDA’s Enforcement Report published in 2022, 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 5, 2026.
2,192of 2,192 medical device recallsshown with your filters
The list
- Medical device recall CytoCell BCL11B Distal in Texas Red Spectrum- Analyte Specific Reagent An error with the chromomap on version 1 of the package insert which is incorrect. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereTexas
- Medical device recall CMV IgM EIA, in vitro diagnostic. Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA). Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report14 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereCalifornia, Colorado, Florida, Georgia, Hawaii, Iowa, Massachusetts, Minnesota, North Carolina, New Hampshire, New Jersey, Pennsylvania, Tennessee and Texas
- Medical device recall Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734 Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereIllinois, Indiana and West Virginia
- Medical device recall MobiCT-32 AIRO Mobile CT Scanner Stryker received a report of a battery fire involving an Airo TruCT unit previously subjected to bypass charging. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereColorado, Tennessee and Utah
- Medical device recall Accelerate PhenoTest BC kit Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report31 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereArkansas, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall Accelerate PhenoTest BC kit Due improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification results for… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report31 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusOngoingWhereArkansas, California, District of Columbia, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, New Jersey, New York, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Virginia, Washington and West Virginia
- Medical device recall GREER M. FAENI, 0.25 mL 20 MG/ML, Item: K6, Analyte Specific Reagent, HYPERSENSITIVITY PNEUMONITIS test… The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Iowa, Kentucky, Massachusetts, Maryland, Missouri, North Carolina, Pennsylvania, Utah and Virginia
- Medical device recall GREER DIA - KIT ANTIGEN M The product was recalled because stability evaluation of the lots indicated a decrease in reactivity that could lead to a potential false-negative result… Class IIFDA’s classDec 7, 2022in FDA’s Enforcement Report11 statesnamed in where it went PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereCalifornia, Colorado, Iowa, Kentucky, Massachusetts, Maryland, Missouri, North Carolina, Pennsylvania, Utah and Virginia
- Medical device recall A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay,… The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Class IIIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 7, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II) The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Class IIIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 7, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall CytoCell BCL11B Proximal in FITC Spectrum-LDT for investigation T-cell related malignancy Device is mislabeled. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedDec 7, 2022ClassClass IIStatusTerminatedWhereTexas
- Medical device recall Alcon Custom Pak Surgical Procedure Pack Due to difficulty removing the liner on the adhesive components of the affected drapes and as a result may render the product unusable. Class IIFDA’s classDec 7, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 49 states named PublishedDec 7, 2022ClassClass 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, 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, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Mighty Bliss Electric Heating Pad, Large The products may have the potential to burn customers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mighty Bliss Electric Heating Pad, Extra-Large The products may have the potential to burn customers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall Mighty Bliss Electric Heating Pad, Large The products may have the potential to burn customers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IStatusOngoingWhereNationwide
- Medical device recall 3M Steri-Drape, Small Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Large Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Large Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Large Towel Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Drape with Adhesive Aperture During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Drape with Adhesive Aperture During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Drape with Incise Film During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Small Drape with Incise Film During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Adhesive Aperture During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Adhesive Aperture During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Incise Film During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Incise Film During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Incise Film and Pouch During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Medium Drape with Incise Film and Pouch During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall 3M Steri-Drape, Urological Drape During a recent investigation, 3M confirmed the liner on the adhesive component of the affected drapes is difficult to remove without damaging the product and… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number… The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereNationwide, and Pennsylvania named
- Medical device recall InControl Insulin Syringes, Short Needle, 29 Gauge, 1CC Insulin syringe retail packages incorrectly labeled as “Short Needle”. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportTexasthe one state its words name PublishedNov 30, 2022ClassClass IIStatusCompletedWhereTexas
- Medical device recall Hamilton-C6 Due to a malfunction related to the backlight on the ventilator screen. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 24 states named PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Idaho, Indiana, Kansas, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Mexico, Nevada, New York, Ohio, Pennsylvania, Puerto Rico, South Carolina, Texas, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Alinity m System Abbott has identified potential performance issues for the Alinity m System software version 1.6.5: 1) In a unique scenario, the waste chute flapper was found… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall MicroScan autoSCAN-4 Instrument Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 15 states named PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide, and Alaska, Florida, Iowa, Idaho, Michigan, Mississippi, Montana, North Carolina, Nebraska, Pennsylvania, South Carolina, Texas, Washington, Wisconsin and West Virginia named
- Medical device recall eSuction Small Cavity Improper device regulatory classification Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report2 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida and Pennsylvania
- Medical device recall K-ASSAY IgA Immunoturbidimetric Assay IgA Reagent may start showing cloudiness over time, which can affect assay performance. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Illinois, Massachusetts, North Carolina, New York, Pennsylvania, Tennessee and Texas named
- Medical device recall Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the… Potential for delay in sending Infusion Start Messages to third-party Electronic Health Record systems which may affect infusion auto-programming on the pump… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report3 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereIndiana, Texas and Virginia
- Medical device recall Unity Total Knee System The internal packaging system for devices may have damage to the blisters potentially damaging the device or compromising the sterility of the packaging. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedNov 30, 2022ClassClass IIStatusTerminatedWherePuerto Rico
- Medical device recall BASIN SET, MEBS42K, general surgical kit Basin Set labeling error: components within the kit are for the Single Basin Set. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereNationwide
- Medical device recall PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4” with EpiLong Soft Catheter, Closed Tip, 19G The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 5 states named PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereNationwide, and California, North Carolina, Pennsylvania, Tennessee and Texas named
- Medical device recall Southmedic SAFETY CARTRIDGE WITH SOUTHMEDIC PLUS SURGICAL BLADE Upon review of its batch record, Southmedic identified that lot # W92761 was not sent out for sterilization, and was instead transferred directly to… Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide, and Illinois named
- Medical device recall VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012 Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VS3 Iridium - Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS) - 785nm Product Number:… XXX Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001 Broken Optical fiber cable damage can occur through handling or bending and can lead to loss of functionality and heating/melting of the outer cable surface. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 30, 2022ClassClass 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.”
Your shortlist0 of 4
Add one more to compare.