Device recall: Thio Med w/o Ind, w/Dex (9ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose…

Class II FDA enforcement event 82683. Recall start date: 17 Apr 2019. Status in the FDA record: Terminated. Termination date: 10 Jul 2020.

Reason for recall, in the words of FDA

Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 106 days after date of manufacturing. Expiration date is shortened from 9 months to 105 days.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Remel Inc started this device recall on 17 Apr 2019. The firm address in the FDA record is in Lenexa, KS. FDA put the recall in Class II. FDA event 82683 has 10 product records. The first FDA enforcement report date is 29 May 2019. The record gives the status Terminated, with the termination date 10 Jul 2020.

FDA enforcement report The 10 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

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,…

Recalling firm

Remel Inc, Lenexa, KS.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

10 product records in the event.

FDA event 82683: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1400-2019	Thio 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	2,395 units	Class II	Terminated	29 May 2019
Z-1401-2019	Thio 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	2,263 units	Class II	Terminated	29 May 2019
Z-1402-2019	Thio 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	736 units	Class II	Terminated	29 May 2019
Z-1403-2019	Thio 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	952 units	Class II	Terminated	29 May 2019
Z-1404-2019	Thio 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	282 units	Class II	Terminated	29 May 2019
Z-1405-2019	Thio 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	248 units	Class II	Terminated	29 May 2019
Z-1406-2019	Thio 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	1,069 units	Class II	Terminated	29 May 2019
Z-1407-2019	Thio 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	888 units	Class II	Terminated	29 May 2019
Z-1408-2019	Thio 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	76 units	Class II	Terminated	29 May 2019
Z-1409-2019	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	27 units	Class II	Terminated	29 May 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2019: 968
Share of these events in Class II: 88%
Product records in this event: 10Median of the firm: 1
Events of the firm on the register: 50

Other events of the firm

Other FDA enforcement events of Remel Inc
Initiated	Product (first record)	Type	Class	Records
3 Jun 2026	GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460	Device	Class II	1
24 Mar 2026	Yeastone Broth, 11ML, 10/BOX YY3462	Device	Class II	1
5 Feb 2026	Campy CVA Medium 100/PK, R01272	Device	Class II	1
12 Nov 2025	1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450	Device	Class II	1
11 Jul 2025	Blood Agar,5% Sheep Blood 100/PK, Product Number R01202	Device	Class II	4
1 May 2025	Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; inv	Device	Class II	1
13 Feb 2025	remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use	Device	Class II	2
12 Feb 2025	Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Se	Device	Class II	1
20 Sep 2024	remel BactiDrop Acridine Orange, REF 21502, 50 per package.	Device	Class II	1
14 Aug 2023	remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containi	Device	Class II	1

Remel Inc: all 50 events

Official channels

FDA enforcement report Z-1400-2019The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 82683. https://recallregister.com/fda/ii/82683/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this 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,…
What quantity of product is in FDA event 82683?: The event has 10 product records. The first record gives this quantity: 2,395 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2019 have the same class?: 88% of the 968 device events that started in 2019 are in Class II.