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 regard LAMINECTOMY, NU01140 Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard FOOT PACK, OR00123Y Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard TOTAL JOINT, OR00446F Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard KYPHOPLASTY, OR01101 Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard BASIC NEURO, NU00259R Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard BASIC NEURO, NU00259S Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SPINE PACK, NU00260H Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard VITRECTOMY PACK, EY00266H Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard NEURO PACK, NU00278L Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard CERVICAL PACK, NU00303H Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard MAJOR EAR, ET00326J Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SHOULDER W BCH CHAIR, OR00356F Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SPINE PACK,NU00395J Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard HAND PACK, OR00594K Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard ACDF, NU00698H Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard ACDF, NU00698I Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard MAJOR CRANI, NU00921E Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard RETINAL PACK, EY00935C Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard VITRECTOMY PK, EY00938C Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SPINE , NU00974F Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall ¿regard CV¿PART¿¿1¿BUNDLE¿- MERCY¿ST¿ANTHONY , CV01005H Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard TOTAL HIP ARTHROPLASTY A&B, OR00032W Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall ¿regard SHOULDER ARTHROSCOPY, OR00049Q Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall ¿regard EYE TRAY, EY00099AE Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard FOOT PACK - MERCY SPRINGFIELD , OR00123Z Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall ¿regard SHOULDER PK, GS00125U Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SHOULDER PACK, GS00125V Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard DAVINCI PACK, GS00137W Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard MINOR NEURO, NU00140AD Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard NEURO TRAY, NU00160R Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SPINE PACK , NU00193N Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard MINOR DAVINCI PACK, GS00349M Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard CATARACT, EY00450K Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard CATARACT, EY00450L Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard PEDIATRIC UROLOGY, GS00467J Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SHOULDER, GS00828G Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard LATERAL SHOULDER, OR01044C Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard HIP ARTHROSCOPY, OR01092B Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SPINE, OR01100A Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall regard SHOULDER ARTHROSCOPY, OR01103A Surgical convenience kits were distributed containing 3M surgical drapes which were subsequently recalled. Class IIFDA’s classNov 30, 2022in FDA’s Enforcement Report4 statesnamed in where it went PublishedNov 30, 2022ClassClass IIStatusTerminatedWhereFlorida, Louisiana, Missouri and North Carolina
- Medical device recall 18239: ASM Omnipod Dash PDM, insulin delivery system The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire… FDA Class I, its most serious class Class IFDA’s class (needs attention)Nov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IStatusTerminatedWhereNationwide
- Medical device recall Endo Stitch V-Loc 180 Absorbable Reload, Models VLOCA004L, VLOCA006L, VLOCA008L, VLOCA204L, VLOCA206L,… Medtronic has received 210 reports of needles breaking during endoscopic suturing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Endo Stitch V-Loc PBT Non-Absorbable Reload, Models VLOCN004L, VLOCN006L, VLOCN008L, VLOCN204L, VLOCN206L,… Medtronic has received 210 reports of needles breaking during endoscopic suturing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET Some of the labels of the kits for product code 10-4001 in the specified lots have an illegible barcode which prevents successful scanning of the package. Class IIIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIIStatusTerminatedWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS MINI CONTAINER 10-1/2 X 7-1/2” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS QTR-LENGTH CONTAINER 12 X 8” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12” Genesis STERRAD Reusable Rigid Sterilization Containers have not consistently met the requirements for aerosol challenge testing. Class IIFDA’s classNov 23, 2022in FDA’s Enforcement ReportNot namedno state, in where it went PublishedNov 23, 2022ClassClass IIStatusOngoingWhereNo state 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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