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Bioseal

United Statesfrom the FDA registration address FDA FEI 2027062

Devices
9
Registrations
FDA
FDA recalls
5

At a glance

Counted by deviCERTS from registry records

Market reach

United States
FDA FEI, FDA recalls

What Bioseal makes

BIOSEAL manufactures single-use medical devices including suction/irrigation tubing, stockinette, pressure bandages, general-purpose surgical scissors, suture retention devices, cast stockinette, tourniquet cuffs, and eye pads.

The company's products are regulated as Class I and Class II devices and are listed in the FDA 510(k) and FDA UDI registries. BIOSEAL is based in the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue9

Newest first, rows 1-9 of 9

  • Gauze Sponge 12PLY Ref K882711

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Surgical Instrument Kit, Disposable Ref K893814

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Rubber Band, Sterile Ref K882695

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Tonsil Sponge, X-Ray Detectable, W/String Ref K882709

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Dermicel, Montgomery Strap Ref K882696

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Gauze Packing, X-Ray Detectable Ref K882707

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Stick Sponge Ref K882712

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Intestinal Sponges Ref K882710

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Fixation Device, Trach Tube Ref K882694

    Active Regimes: 510(k) Registry: 510(k) Class:I

Company details

FDA FEI number
2027062
DUNS number
186968939
Address
167 WEST ORANGETHORPE AVE., PLACENTIA, CA, 92870

FDA recalls5

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 5 recalls initiated by BIOSEAL, the earliest on 2017-10-18 and the most recent on 2021-03-23. By recorded status: 1 terminated and 4 with another status. The reasons filed fall into these groups: packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

  • 2017 1
  • 2018 0
  • 2019 1
  • 2020 0
  • 2021 3
  • 2022 0
  • 2023 0
  • 2024 0
  • 2025 0
  • 2026 0

  • 2021

    • 23 Mar 2021 Z-1622-2021 Class II Completed Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. Distribution: US: IL and MO OUS: None
    • 23 Mar 2021 Z-1623-2021 Class II Completed Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. Distribution: US: IL and MO OUS: None
    • 23 Mar 2021 Z-1624-2021 Class II Completed Pre-op skin prep component ChloraPrep included within kits may allow the growth of Aspergillus penicillioides, which may penetrate the packaging resulting in a breach of the package integrity. Distribution: US: IL and MO OUS: None

  • 2019

    • 15 Aug 2019 Z-2795-2020 Class II Terminated The reported stress crack in the port of the swivel elbow where the flip cap is inserted could result in leakage from the breathing system resulting in the prescribed ventilation not being delivered to the patient. These cracks could possibly leak if they reach a significant size and pose a serious heath risk to patient. Distribution: US Nationwide distribution including in the state of CA.

  • 2017

    • 18 Oct 2017 Z-0085-2018 Class II Completed Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date. Distribution: CA, IL, NC, VT

Frequently asked questions

How many devices does BIOSEAL have in the registry?

The registry currently lists 9 devices for BIOSEAL. Devices recorded under merged duplicate company entries are counted once.

Which registries list BIOSEAL's devices?

Among its 9 most recently registered devices, BIOSEAL has devices listed in FDA 510(k) (9 devices).

What risk classes do BIOSEAL's devices fall under?

Among its 9 most recently registered devices, the classes recorded for BIOSEAL's devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for BIOSEAL?

FDA recall records list 5 recalls initiated by BIOSEAL, the most recent initiated on 23 Mar 2021. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from BIOSEAL in the registry?

The most recently registered devices listed for BIOSEAL include GAUZE SPONGE 12PLY, SURGICAL INSTRUMENT KIT, DISPOSABLE, RUBBER BAND, STERILE and TONSIL SPONGE, X-RAY DETECTABLE, W/STRING.

Generated automatically from registry data and not verified by a human reviewer.