Remel Thio Med w/o Ind, w/Dex Recalled for Potential Performance Failure
Remel Inc is recalling 27 units of Thio Med w/o Ind, w/Dex due to potential failure in performance testing after 106 days.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a moderate severity score when no hospitalizations or significant injuries are reported, and the hazard is a theoretical performance failure.
Plain-English summary
Remel Inc is recalling 27 units of Thio Med w/o Ind, w/Dex (18ml) 20/PK. This product is a general purpose media recommended for use in qualitative procedures for the cultivation of aerobes and anaerobes.
The recall is issued because the products have the potential to fail performance testing per the Instructions for Use (IFU) starting at 106 days after the date of manufacturing. Consequently, the expiration date is being shortened from 9 months to 105 days.
The affected lots are identified by Material Number R08858 and Lot Numbers 343868 (02/14/2019), 369544 (04/08/2019), and 387018 (05/09/2019). The products were distributed nationwide in the United States and internationally to Canada. Users should check their inventory for these specific lot numbers and discontinue use if the product is past the revised 105-day expiration window.
The recalled product
- Product
- Thio Med w/o Ind, w/Dex (18ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 27
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 (4)
- Material Number: R08858
- Lot Number (Labeled Expiration Date): 343868 (02/14/2019)
- 369544 (04/08/2019)
- 387018 (05/09/2019).
Distribution
Part of a larger recall action
This product is one of 10 recalled by Remel 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 10 products in this recall →Related recalls
Same manufacturer · Remel Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighBlood MacConkey biplates may carry Listeria monocytogenes surface contamination
FDA (Devices) · 2025-08-06
Same hazard · performance failure
See all →- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateRemel Neisseria meningitidis Gp C In Vitro Diagnostics Recall
FDA (Devices) · 2026-08-19