The Recall Desk

FDA (Devices) recall action 87577

Oto Med Inc recalled 3 products on 2021-05-12

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2021-05-12
Critical
0
Units
18,842

Why these products were recalled

During internal Age Testing, holes were found in the sterile Tyvek pouches of the devices.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Devices)··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
    Distribution
    43 states
  • ModerateFDA (Devices)··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
    Distribution
    43 states
  • ModerateFDA (Devices)··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
    Distribution
    43 states