The Recall Desk

Manufacturer

Creganna Medical Devices

5 recalls in our database name Creganna Medical Devices as the manufacturing or recalling firm.

What the numbers show

Total
5
Critical
0
Severe
2
Most recent
2023-08-09

Of the 5 recalls from Creganna Medical Devices we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (40%) 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.

1–5 of 5

  • ModerateFDA (Devices)·Z-2249-2023·2023-08-09

    Gore Tips Set Device Recall: Incorrect Expiration Date Labeling

    Creganna Medical Devices is recalling three lots of Gore Tips Set Device due to incorrect expiration date labeling. Affected devices may be used past their actual expiration date.

    Product
    Gore Tips Set Device, Catalog Number TSET1016, percutaneous liver access
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2529-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues

    Creganna Medical Devices is recalling 85 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Devices)·Z-2532-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Sterility Assurance Issues

    Creganna Medical Devices is recalling 50 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2531-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 100 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2530-2017·2017-06-21

    Boston Scientific Steerable Sheath Recalled for Lack of Sterility Assurance

    Creganna Medical Devices is recalling 150 units of Boston Scientific Zurpaz Steerable Sheaths due to a lack of sterility assurance. The devices were distributed in Massachusetts.

    Product
    Boston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
    Category
    Medical Device
    Distribution
    1 state