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Lower risk Medical device recall · FDA · Published April 17, 2019

Remel Thio Med w/o Ind w/Dex 20-Pack: Shortened Expiration Risk

Remel recalls Thio Med w/o Ind w/Dex 20-pack due to shortened expiration date (105 days) from 9 months to prevent performance failures in testing.

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

🇺🇸 FDA recall #Z-1409-2019Medical deviceRemel ›
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Contact the company

Recalling firmRemel Inc12076 Santa Fe Trail Dr · Lenexa, KS 66215-3519
✎ GovInfoNow plain-language explainer

Remel is recalling Thio Med w/o Ind w/Dex 20-packs because the expiration date is shortened from 9 months to 105 days. This could cause the product to fail performance testing after 106 days from manufacturing. Read more at govinfonow.com/recall/68319-remel-thio-med-w-o-ind-w-dex-20-pack.

Source Summary by GovInfoNow · govinfonow.com/recall/68319-remel-thio-med-w-o-ind-w-dex-20-pack · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1409-2019

Cite this page

“Remel Thio Med w/o Ind w/Dex 20-Pack: Shortened Expiration Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/68319-remel-thio-med-w-o-ind-w-dex-20-pack. Based on FDA recall #Z-1409-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1409-2019%22&limit=1).

The FDA announced on April 17, 2019, that Remel Inc is recalling Thio Med w/o Ind, w/Dex (18ml) 20/PK products due to potential performance failures. The agency shortened the expiration date from nine months to 105 days after manufacturing.

How to tell if you have it

  • Brand: Remel
  • Product Name: Thio Med w/o Ind, w/Dex (18ml) 20/PK
  • Material Number: R08858
  • Lot Numbers: 343868 (Expiration Date: 02/14/2019), 369544 (Expiration Date: 04/08/2019), 387018 (Expiration Date: 05/09/2019)
  • Distribution: Worldwide, including U.S. states AK through WY and Puerto Rico, and Canada

The hazard

The products may fail performance testing according to the Instructions for Use starting at 106 days after the date of manufacturing. The FDA said this risk led to the expiration date being shortened from nine months to 105 days.

Context

GovInfoNow's records show Remel, Inc has issued 22 other recalls since November 2, 2017. Recent brand recalls include a June 3, 2026 recall of Remel GC Agar Base for reduced Neisseria gonorrhoeae recovery risk and a March 24, 2026 recall of Remel Yeastone Broth for incorrect lab results risk. Other recent recalls of similar products include Cook Medical Spectrum Central Venous Tray Recall (March 5, 2026), Cook Staged Extubation Set (March 5, 2026), and Cook Medical Thal-Quick Chest Tube Tray Recall (March 5, 2026).

How to tell if you have this one

Check for lot numbers 343868 (02/14/2019), 369544 (04/08/2019), or 387018 (05/09/2019) on the product label. The product is sold as a 20-pack for qualitative procedures in labs or medical settings.

  • Brand
    Remel
  • Category
    Medical device
FDA recall event · 10 products

All 10 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Canada.
Recall numberProduct, codes & lotsQuantity
Z-1400-2019Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R064700; Lot Number (Labeled Expiration Date): 298271 (11/26/2018), 314882 (12/24/2018), 316605 (12/26/2018), 318895 (12/31/2018), 323453 (01/08/2019), 326336 (01/14/2019), 327633 (01/15/2019), 328655 (01/16/2019), 329879 (01/17/2019), 332323 (01/23/2019), 335242 (01/29/2019), 337936 (02/05/2019), 339205 (02/06/2019), 345315 (02/19/2019), 346704 (02/27/2019), 353569 (03/06/2019), 359076 (03/18/2019), 360812 (03/20/2019), 363509 (03/26/2019), 369554 (04/08/2019), 371214 (04/10/2019), 373080 (04/15/2019), 377500 (04/23/2019), 380469 (04/29/2019), 381209 (04/30/2019), 388688 (05/14/2019), 392556 (05/21/2019), 396644 (05/30/2019), 398292 (06/10/2019), 408612 (06/24/2019), 417772 (07/17/2019), 420556 (07/24/2019). Expansion Lot Number (Labeled Expiration Date): 423579(07/31/2019)2,395 units
Z-1401-2019Thio Med w/Dex, Hem, Vit K (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R064720; Lot Number (Labeled Expiration Date): 298486 (11/27/2018), 309147 (12/12/2018), 313760 (12/20/2018), 314883 (12/24/2018), 316606 (12/26/2018), 320904 (01/01/2019), 325887 (01/10/2019), 329880 (01/17/2019), 337679 (02/04/2019), 340776 (02/11/2019), 342665 (02/13/2019), 347320 (02/28/2019), 354828 (03/07/2019), 358178 (03/14/2019), 359886 (03/19/2019), 363510 (03/26/2019), 367408 (04/02/2019), 369555 (04/08/2019), 372099 (04/11/2019), 373073 (04/15/2019), 374683 (04/17/2019), 379731 (04/25/2019), 385227 (05/07/2019), 388691 (05/14/2019), 389364 (05/15/2019), 393231 (05/22/2019), 398293 (06/10/2019), 404758 (06/13/2019), 417773 (07/17/2019).2,263 units
Z-1402-2019Thio Med w/o Ind, w/Dex (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R064702; Lot Number (Labeled Expiration Date): 303274 (11/29/2018), 327634 (01/15/2019), 359077 (03/18/2019), 379729 (04/25/2019), 391553 (05/20/2019). Expansion Lot Number (Labeled Expiration Date): 423547 (07/30/2019)736 units
Z-1403-2019Thio Med w/Dex, Hem, Vit K (9ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R064722; Lot Number (Labeled Expiration Date): 314201 (12/20/2018), 337680 (02/04/2019), 346705 (02/27/2019), 362709 (03/25/2019), 380471 (04/29/2019), 396517 (05/28/2019).952 units
Z-1404-2019Thio Med w/o Ind, w/Dex (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R08852; Lot Number (Labeled Expiration Date): 307916 (12/11/2018), 337081 (01/31/2019), 359857 (03/19/2019), 381201 (04/30/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019). Material Number: R07178; Lot Number (Labeled Expiration Date): 311677 (12/18/2018), 347391 (02/28/2019), 366062 (03/28/2019), 390570 (05/16/2019), 396653 (05/30/2019), 417781 (07/17/2019).282 units
Z-1405-2019Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R07176; Lot Number (Labeled Expiration Date): 309154 (12/12/2018), 328732 (01/16/2019), 340307 (02/07/2019), 362767 (03/25/2019), 366061 (03/28/2019), 386121 (05/08/2019), 392563 (05/21/2019), 404767 (06/13/2019). Expansion Lot Number (Labeled Expiration Date): 435420 (08/13/2019). Material Number: R8850; Lot Number (Labeled Expiration Date): 329867 (01/17/2019), 354771 (03/07/2019), 377024 (04/22/2019), 394853 (05/23/2019), 417667 (07/16/2019).248 units
Z-1406-2019Thio Med w/Dex, Hem, Vit K (10ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R07182; Lot Number (Labeled Expiration Date): 309155 (12/12/2018), 329971 (01/17/2019), 346674 (02/26/2019), 354842 (03/07/2019), 376323 (04/18/2019), 398234 (06/06/2019), 404772 (06/13/2019).1,069 units
Z-1407-2019Thio Med w/Dex, Hem, Vit K(10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R07180; Lot Number (Labeled Expiration Date): 314206 (12/20/2018), 315673 (12/25/2018), 322659 (01/07/2019), 330648 (01/21/2019), 333828 (01/24/2019), 337102 (01/31/2019), 343936 (02/14/2019), 347392 (02/28/2019), 353577 (03/06/2019), 366056 (03/28/2019), 367423 (04/02/2019), 370220 (04/09/2019), 377044 (04/22/2019), 380480 (04/29/2019), 390571 (05/16/2019), 391563 (05/20/2019), 407306 (06/20/2019), 418374 (07/18/2019).888 units
Z-1408-2019Thio Med w/o Ind, w/Dex (18ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes; Material Number: R08856; Lot Number (Labeled Expiration Date): 314864 (12/24/2018), 343867 (02/14/2019), 367396 (04/02/2019), 387017 (05/09/2019). Expansion Lot Number (Labeled Expiration Date): 423518 (07/30/2019).76 units
Z-1409-2019Thio 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; Material Number: R08858; Lot Number (Labeled Expiration Date): 343868 (02/14/2019), 369544 (04/08/2019), 387018 (05/09/2019).27 units
Based on the official FDA remedy

What to do — step by step

  1. Check Expiration Date

    Verify the product's expiration date is within 105 days of manufacturing for safe use.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 49 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide Distribution -US Nationwide to AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Apr 17, 201912. FDA classified it Class II: May 22, 201923. Published in FDA’s Enforcement Report: May 29, 201934. FDA terminated the recall: Jul 10, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

How do I know if I have the recalled product?

Look for the lot numbers listed above on the product label, which are specific to this recall.

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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-1409-2019 (April 17, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1409-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 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.