Bioseal Inc.
BIOSEAL · Model 17624/25 · UDI-DI 00630094762425
10
510(k) clearances
866
Adverse events (2 deaths)
38
Recalls
228
Facilities
Description
Dental Wire
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-04-09 | MEDLINE INDUSTRIES, LP - Northfield | Three is the potential for the retractors to puncture through the sterile packaging. |
| 2024-02-23 | MEDLINE INDUSTRIES, LP - Northfield | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. |
| 2022-10-12 | Medical Action Industries, Inc. 306 | Scissors contained debris. |
| 2021-05-11 | Medical Action Industries, Inc. 306 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits |
| 2021-05-11 | Medical Action Industries, Inc. 306 | There is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits |
| 2016-08-01 | Ethicon, Inc. | ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product c |
| 2011-03-28 | Hospira Inc. | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| 2011-03-28 | Hospira Inc. | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| 2011-03-28 | Hospira Inc. | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
| 2011-03-28 | Hospira Inc. | There is a potential for the air filter at the distal end of the set to become detached. This could result in the contamination of the sterile fluid path inside the tubing. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.