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 ACE Surgical Supply, 17539 CUSTOM KIT STERILE Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Perio Surgery Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BASIC IMPLANT PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surg Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surgical Pk Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surg Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Basic Implant Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surgical Pk Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Surg Pk Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical room, SURGICAL PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Implants Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical room, Implant Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, DENTAL CUSTOM PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Custom Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Surgical room, DENTAL SURGICAL PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, COTTON APPLICATOR 3” Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, SAFETY PINS, SMALL 1” Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, Introducer Kit Micro Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall STRADIS HEALTHCARE, PROBE COVER W/GEL PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Breast Augmentation tray Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Vein Clinics 1 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Novasure Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, SURGICAL PAIN TRAY Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, PROCEDURE KIT Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Basin Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Basin Set Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, BREAST PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, GYN PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, ENT PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, BASIC PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, VEIN TRAY Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, ENT SET UP PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, OMFS Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, MAJOR EXTREMITY PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, UNIVERSAL TRAY Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, CATH PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, PACEMAKER PACK IItem No.570-2793 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, TEMP STIMULATOR SUPPLIES Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, BASIC EXTENDED PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, LOOP RECORDER PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, PROCEDURE TRAY Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Knee Pack Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, CATH ANGIO PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, EXTREMITY PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, Amnio Tray Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, RHINO PACK Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 2022ClassClass IIStatusOngoingWhereNationwide
- Medical device recall HENRY SCHEIN, CUSTOM PK 2 Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may… Class IIFDA’s classDec 21, 2022in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 21, 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.”
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