The Recall Desk

Manufacturer

Gyrus Medical, Inc

4 recalls in our database name Gyrus Medical, Inc as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2014-10-29

Of the 4 recalls from Gyrus Medical, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) 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.

1–4 of 4

  • ModerateFDA (Devices)·Z-0100-2015·2014-10-29

    Gyrus Medical Recalls Sterile Surgical Forceps and Scissors Due to Seal Defects

    Gyrus Medical is recalling specific sterile surgical forceps and scissors because a packaging anomaly may compromise the sterile barrier.

    Product
    GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5m
    Category
    Medical Device
    Distribution
    22 states
  • ModerateFDA (Devices)·Z-2269-2014·2014-08-27

    Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales

    Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.

    Product
    Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1196-2014·2014-03-19

    Gyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits

    Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.

    Product
    Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enable
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1983-2013·2013-08-28

    Gyrus Medical Recalls Sterile Bipolar Dissecting Forceps Due to Seal Failure

    Gyrus Medical is recalling 1,140 sterile bipolar dissecting forceps units because accelerated aging tests showed a compromised sterile packaging seal.

    Product
    GYRUS ACMI, REF 3740, Everest BiCOAG Bipolar Dissecting Forceps 5mm/45 cm, Sterile EO. GYRUS ACMI, REF 3740PK, or REF 94201PK, PKS LYONS, Dissecting Forceps 5mm/45cm, Sterile EO. The Dissectors are sterile, single use electrosurgical devices that are indicated for the elec
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

GYRUS MEDICAL LIMITED

Source: Wikidata (Q139908186), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.