Transfer Device REF 2008S Sterile Barrier Packaging Defect Recall
Microtek Medical's Transfer Device REF 2008S is being recalled due to pin holes and tears in the sterile packaging barrier identified during testing. These defects compromise sterility and could allow contamination.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Medical device with compromised sterile barrier integrity (pin holes and tears in packaging) represents a risk-of-harm product where injury has not yet been reported, meeting Score 3 per the rubric criteria.
Plain-English summary
Microtek Medical Inc. is recalling the Transfer Device, REF 2008S. The device is packaged using a form, fill, and seal machine with poly/Tyvek material and supplied in cases of 50 units.
During sterile barrier testing, samples were found to have pin holes and tears in the packaging film. These defects compromise the integrity of the sterile barrier.
The recall affects 11,781 cases (589,050 units) distributed nationwide and internationally to Canada, Mexico, New Zealand, Belize, and Hong Kong. Multiple lot numbers are impacted.
Customers should immediately stop using affected Transfer Device units and contact Microtek Medical Inc. for instructions regarding return or replacement of the recalled products.
The recalled product
- Product
- Transfer Device, REF 2008S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Manufacturer
- Microtek Medical Inc.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- SKU/UDI-Device Identifier: 2008S/00748426002535
- Lot Numbers: 210924
- 190828
- 190312
- 190527
- 190507
- 190528
- 181022
- 181224
- 190717
- 181226
- 181225
- 190410
- 180828
- 211115
- 210924
- 210922
- 210923
- 210807
- 210805
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Microtek Medical Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
Same manufacturer · Microtek Medical Inc.
See all →- SevereMicrotek Patient Drape Adapter Plug Kits Recalled for Non-Sterile Labeling
FDA (Devices) · 2025-06-18
- HighBag Decanter II Medical Device Recalled for Sterile Packaging Defects
FDA (Devices) · 2024-08-28
- ModerateC-Flow Bag Decanter Packaging Defects Prompt Sterile Barrier Recall
FDA (Devices) · 2024-08-28
- HighBottle Decanter REF 2004S Recalled for Sterile Barrier Packaging Defects
FDA (Devices) · 2024-08-28
- HighVial Decanter Medical Device Recalled for Compromised Sterile Packaging
FDA (Devices) · 2024-08-28
Same hazard · sterile barrier defect
See all →- HighSurgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA (Devices) · 2026-08-19
- HighPruitt Irrigation Occlusion Catheter Recalled for Incomplete Sterile Seals
FDA (Devices) · 2025-05-21
- HighPruitt Occlusion Catheter Recalled Due to Incomplete Sterile Barrier Seals
FDA (Devices) · 2025-05-21
- HighB Braun Interventional ELITE HV Hemostasis Valve Introducer System Recall
FDA (Devices) · 2025-05-14
- HighSocrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect
FDA (Devices) · 2025-03-05