Lower risk Medical device recall · FDA · Published October 18, 2017

Bioseal surgical kits recalled due to expired prep pads

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0085-2018Medical device Bioseal ›

Lower-risk recall

Custom surgical kits contain Aplicare Providone Iodine Prep Pads which were subsequently recalled by Medline Industries for in incorrect expiration date.

Take action

Contact the company

Recalling firmBioseal Corporation167 W Orangethorpe Ave · Placentia, CA 92870-6922

✎ GovInfoNow plain-language explainer

Bioseal Corporation is recalling custom surgical kits that contain Aplicare Providone Iodine Prep Pads with incorrect expiration dates. This recall follows Medline Industries' earlier recall of the same prep pads, which could lead to improper sterilization or infection risks if used. Read more at govinfonow.com/recall/72813-bioseal-surgical-kits-recalled-due-to-expired-prep-pads.

Source Summary by GovInfoNow · govinfonow.com/recall/72813-bioseal-surgical-kits-recalled-due-to-expired-prep-pads · Updated September 14, 2026 · FDA enforcement record: FDA #Z-0085-2018

Cite this page

“Bioseal surgical kits recalled due to expired prep pads.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/72813-bioseal-surgical-kits-recalled-due-to-expired-prep-pads. Based on FDA recall #Z-0085-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0085-2018%22&limit=1).

Bioseal Corporation recalled custom surgical kits due to included Aplicare Providone Iodine Prep Pads with incorrect expiration dates, according to the FDA. The Food and Drug Administration announced this Class II recall on October 18, 2017.

How to tell if you have it

Brand: Bioseal
Suture Removal Set, 910-0002 (Lot Numbers: 400348, 400354, 400364, 400370, 400386)
Instrument Set, INST03/20 (Lot Numbers: 400349, 400354, 400361, 400364, 400366, 400367, 400370, 400372, 400373, 400380, 400386, 400392, 400393, 400393, 400396, 400396, 400399, 400401, 400403, 400414, 400416, 400417, 400419, 400422, 400427)
Suture Removal Set, SUT309/100 (Lot Numbers: 400346, 400354, 400361, 400364, 400366, 400370, 400373, 400396, 400397, 400403, 400407, 400408, 400413, 400430, 400354, 400361, 400370, 400373, 400407, 400408, 400413, 400370, 400396, 400408, 400430, 400346, 400354, 400361, 400362, 400364, 400370, 400397, 400373, 400396, 400397, 400403, 400407, 400408, 400413, 400427, 400430, 400354)
Incision & Drainage Tray, INC03/20 (Lot Number: 1137)
Suture Removal Set, SUT103/50 (Lot Numbers: 400413, 400413, 400413, 400416, 400430, 400396, 400396, 400401, 400402, 400403, 400416)
General Purpose Tray, GPT010/25 (Lot Numbers: 400348, 400351, 400355, 400364, 400369, 400376, 400385, 400389, 400395, 400402, 400414, 400422)
General Purpose Tray, GPT002/50 (Lot Numbers: 400348, 400356, 400361, 400364, 400376, 400380, 400393, 400394, 400399, 400402, 400407, 400418, 400422, 400422, 400430)
Distribution: CA, IL, NC, VT
Units affected: 51635

The hazard

The custom surgical kits contain Aplicare Providone Iodine Prep Pads that were subsequently recalled by Medline Industries for having an incorrect expiration date.

Context

GovInfoNow's records show Bioseal Corporation has 2 other recalls on record since 2019-08-15. On 2021-03-23, Bioseal issued a Central Line Dressing Kit Recall due to the risk of Aspergillus growth in pre-op skin prep. On 2019-08-15, Bioseal recalled Trachea Extenders because of a reported stress crack in the port of the swivel elbow resulting in breathing system leakage. Other recent recalls of similar products include Medline Medical Kits Recall (2026-03-16), Medline Centurion Kits with Contaminated Alcohol Prep Pads Recalled (2026-03-16), and Medline Centurion Shave Kits Recall: Non-sterile Alcohol Prep Pads Risk Infection (2026-03-16).

How to tell if you have this one

Check for kits labeled with model numbers: Suture Removal Set (910-0002), Instrument Set (INST03/20), Suture Removal Set (SUT309/100), Incision & Drainage Tray (INC03/20), Suture Removal Set (SUT103/50), General Purpose Tray (GPT010/25), or General Purpose Tray (GPT002/50). Also check the lot numbers listed in the recall notice.

Brand
Bioseal
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Kit Labels
Look for specific model numbers and lot numbers listed in the recall notice to confirm if your kit is affected.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “CA, IL, NC, VT” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Illinois, North Carolina, Vermont.

Recall timeline

FDA published this recall 28 days after the firm started it.

Oct 18, 2017Firm started the recall
Nov 9, 2017FDA classified it Class II
Nov 15, 2017Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/72813-bioseal-surgical-kits-recalled-due-to-expired-prep-pads">Bioseal surgical kits recalled due to expired prep pads (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0085-2018 (October 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0085-2018 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.