The Recall Desk

Manufacturer

Oto Med Inc

3 recalls in our database name Oto Med Inc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
0
Most recent
2021-05-12

Of the 3 recalls from Oto Med 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.

1–3 of 3

  • ModerateFDA (Devices)·Z-1520-2021·2021-05-12

    Oto Med Recalls Bone Dust Collectors Due to Sterile Pouch Defects

    Oto Med Inc is recalling 5,092 Grace Medical Cox Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-3500 *** COX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1521-2021·2021-05-12

    Oto Med Recalls SpineX Bone Dust Collectors Due to Sterile Pouch Defects

    Oto Med Inc is recalling 415 SpineX Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-4500 *** spineX BONE DUST COLLECTOR *** 2 stainless steel filters - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1519-2021·2021-05-12

    Oto Med Recalls Sheehy Bone Dust Collectors Due to Packaging Defects

    Oto Med Inc is recalling 13,335 Sheehy Bone Dust Collectors because holes were found in the sterile Tyvek pouches during internal testing.

    Product
    Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: intended to be inserted into a suction tube during the early stages of otologic surgery to collect bone particles for future use.
    Category
    Medical Device
    Distribution
    Distributed nationwide