The Recall Desk

Manufacturer

Medtronic

47 recalls in our database name Medtronic as the manufacturing or recalling firm.

What the numbers show

Total
47
Critical
0
Severe
9
Most recent
2017-06-21

Of the 47 recalls from Medtronic we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 9 (19%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 47

  • SevereFDA (Devices)·Z-2547-2017·2017-06-21

    Medtronic Recalls Custom Suture Packs Due to Potential Seal Defects

    Medtronic is recalling custom suture packs because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    CUSTOM SUTURE PACK; Item Number: US1540 and US1614
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2543-2017·2017-06-21

    Medtronic Recalls Endo Stitch Polysorb Sutures Due to Seal Defect

    Medtronic is recalling specific Endo Stitch Polysorb sutures because an incomplete inner package seal may cause the material to degrade prematurely.

    Product
    Sutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2548-2017·2017-06-21

    Medtronic Recalls Pacemaker Angio X3 Due to Potential Seal Defect

    Medtronic is recalling 478,465 units of the Pacemaker Angio X3 because an incomplete seal on the inner package may cause the suture material to degrade prematurely.

    Product
    SCHRITTMACHER ANGIO X3; Item Number: 4045255423347
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2542-2017·2017-06-21

    Medtronic Recalls MAXON Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific MAXON sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2544-2017·2017-06-21

    Medtronic Recalls BIOSYN Sutures Due to Potential Incomplete Seal

    Medtronic is recalling BIOSYN sutures because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2546-2017·2017-06-21

    Medtronic Recalls USPACK Suture Kits Due to Potential Seal Defects

    Medtronic is recalling USPACK-SUTURE KITs (Item US1672) because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    USPACK-SUTURE KIT; Item Number: US1672
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2545-2017·2017-06-21

    Medtronic Recalls Best Practice Kits Due to Potential Seal Defects

    Medtronic is recalling Best Practice Kits because an incomplete seal may cause the suture material to degrade prematurely.

    Product
    Best Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2541-2017·2017-06-21

    Medtronic Recalls Polysorb Sutures Due to Potential Incomplete Seal

    Medtronic is recalling specific Polysorb suture products because an incomplete inner package seal may cause the suture material to degrade prematurely.

    Product
    Sutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60"
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1473-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.

    Product
    SharkCore Fine Needle Biopsy System (22 GA); Material/Part #s: DSC-22-01
    Category
    Medical Device
    Distribution
    40 states
  • HighFDA (Devices)·Z-1474-2017·2017-03-22

    Medtronic SharkCore Fine Needle Biopsy System Recalled for Handle Breakage

    Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.

    Product
    SharkCore Fine Needle Biopsy System (25GA); Material/Part#: DSC-25-01
    Category
    Medical Device
    Distribution
    40 states
  • SevereFDA (Devices)·Z-0889-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 1,293,169 Clearify Visualization Systems because a breach of the sterile barrier compromises product sterility.

    Product
    Covidien Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0890-2017·2016-12-28

    Medtronic Recalls Clearify Visualization Systems Due to Sterility Compromise

    Medtronic is recalling 230 Clearify Visualization Systems because the sterile barrier was breached, compromising product sterility. The recall covers worldwide distribution.

    Product
    Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2567-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Flat L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 119,770 units distributed worldwide.

    Product
    Valleylab Laparoscopic Flat L-Hook Electrode 36CM Item Code: E277436 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2575-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 50,055 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R36ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction v
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2563-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrodes Recalled for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall affects 6,381 units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 45CM Item Code: E277145 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sing
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2558-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Argon Modified Flat l Electrodes due to a potential sterile barrier breach.

    Product
    Valleylab Laparoscopic Argon Modified Flat l Electrode 28CM Item Code: E258128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2569-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Curved Spatula Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Curved Spatula Electrode 28CM Item Code: E278128 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a sin
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2566-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the package may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 45CM Item Code: E277345 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2574-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire L-Hook Electrodes due to a potential sterile barrier breach. The recall covers 63,320 units distributed worldwide.

    Product
    Valleylab Laparoscopic Wire L-Hook Electrode Retractable Item Code: E2783R28ASP The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction vi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2578-2016·2016-08-24

    Medtronic Valleylab Laparoscopic Electrode Recall for Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Cylindrical Tip Electrodes due to a potential sterile barrier breach. The recall covers units distributed worldwide.

    Product
    Valleylab Laparoscopic Cylindrical Tip Electrode 28CM Item Code: E278628 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a si
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2565-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Electrodes Due to Sterile Barrier Compromise

    Medtronic is recalling Valleylab Laparoscopic Wire J-Hook Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Wire J-Hook Electrode 36CM Item Code: E277336 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction via a single
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2555-2016·2016-08-24

    Medtronic Recalls Valleylab Laparoscopic Argon Electrodes Due to Sterile Barrier Risk

    Medtronic is recalling 19,200 Valleylab Laparoscopic Flexible Argon Electrodes because the packaging may be compromised, potentially breaching the sterile barrier.

    Product
    Valleylab Laparoscopic Flexible Laparoscopic Argon Electrodes 3" Item Code: E25303 The Valleylab Laparoscopic Handset and Electrodes are indicated for use in laparoscopic and thoracoscopic surgical procedures where the delivery of electrosurgical current, irrigation and suction
    Category
    Medical Device
    Distribution
    Distributed nationwide