Bioseal Corporation recalls
Every recall we track for Bioseal Corporation — 5 in all, from 2017–2021 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Bioseal Corporation peaked in 2021 (3); 5 since 2017. 40% rated “stop using now”.
All FDA recall records for Bioseal Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 1 | 0 | 1 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 1 | 0 | 1 | 1 | 3 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Bioseal Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Bioseal Corporation recalls
3 shown- Stop using nowMedical device
Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only,
Bioseal recalls central line dressing kits with ChloraPREP applicator due to potential Aspergillus penicillioides growth that could breach packaging. Affected lots include 400521, 400514, and others. Stop using immediately.
BiosealMar 23, 2021 - Stop using nowMedical device
Bioseal Corporation recalls Bioseal Trachea Extender 1/pl 50pk/Cs, REF TRAX01/50, LOT XXXX, STERILE EO, Single Use Only, Date of Manufacture XXXX,
Bioseal recalls trachea extenders with potential stress cracks causing breathing system leaks. Patients may not receive proper ventilation. Stop using immediately if you have the recalled model.
BiosealAug 15, 2019 - Lower riskMedical device
Bioseal Corporation recalls Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture
Bioseal Corporation recalls custom surgical kits with expired Aplicare Providone Iodine Prep Pads. These kits may have incorrect expiration dates from Medline Industries' recall. Affected kits include specific models and lot numbers listed in the notice.
BiosealOct 18, 2017
Bioseal Corporation recall questions
How many recalls has Bioseal Corporation had?
5 recalls from Bioseal Corporation are on record with U.S. safety agencies, from 2017–2021.
What is the most recent Bioseal Corporation recall?
Bioseal Corporation recalls Bioseal, Central Line Dressing Kit, containing ChloraPREP Applicator 3 mL, REF: CVC009/20, Sterile EO, Single Use Only,, dated Mar 23, 2021. Every Bioseal Corporation recall is listed on this page, newest first.
What should I do if I have a recalled Bioseal Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Bioseal Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.