Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Custom surgical kits labeled as follows: (a) Suture Removal Set Recalled by Bioseal Corporation Due to Custom surgical kits contain Aplicare Providone Iodine Prep...

Date: October 18, 2017
Company: Bioseal Corporation
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Bioseal Corporation directly.

Affected Products

Custom surgical kits labeled as follows: (a) Suture Removal Set, 910-0002 (b) Instrument Set, INST03/20 (c) Suture Removal Set, SUT309/100 (d) Incision & Drainage Tray, INC03/20 (e) Suture Removal Set, SUT103/50 (f) General Purpose Tray, GPT010/25 (g) General Purpose Tray, GPT002/50

Quantity: 51635 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed to 4 states: CA, IL, NC, VT

Affected (4 states)Not affected

About Bioseal Corporation

Bioseal Corporation has 5 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report