Remel Thio Med w/Dex, Hem, Vit K Media Recalled for Performance Failure
Remel Inc is recalling Thio Med w/Dex, Hem, Vit K media because it may fail performance testing after 57 days. The expiration date is shortened to 56 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: This is an FDA Class II recall involving a performance defect in a medical device where no injuries or illnesses have been reported, fitting the criteria for a moderate severity rating.
Plain-English summary
Remel Inc is recalling 133 units of Thio Med w/Dex, Hem, Vit K (7ml) 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 due to a potential for the products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after the date of manufacturing. As a result, the expiration date is shortened from 7 months to 56 days.
The affected lots are 303285 (expiration 09/27/2018), 309151 (expiration 10/10/2018), and 353575 (expiration 01/02/2019). The products were distributed nationwide to 44 states and Puerto Rico, as well as internationally to Singapore. No illnesses or injuries have been reported in connection with this recall.
Users should check their inventory for the specific lot numbers listed above. If the product is found, it should be quarantined and not used. Users should contact Remel Inc for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Thio Med w/Dex, Hem, Vit K (7ml) 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
- 133
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 (3)
- Lot Number (Expiration Date): 303285 (09/27/2018)
- 309151 (10/10/2018)
- 353575 (01/02/2019).
Distribution
Part of a larger recall action
This product is one of 4 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 4 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