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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82683

10 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 17, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Remel Inc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

10 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 10

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

Z-1400-2019
Recall number
Z-1400-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
2,395 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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)

Distribution pattern

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.

device · product 2 of 10

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

Z-1401-2019
Recall number
Z-1401-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
2,263 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 3 of 10

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

Z-1402-2019
Recall number
Z-1402-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
736 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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)

Distribution pattern

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.

device · product 4 of 10

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

Z-1403-2019
Recall number
Z-1403-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
952 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 5 of 10

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

Z-1404-2019
Recall number
Z-1404-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
282 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 6 of 10

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

Z-1405-2019
Recall number
Z-1405-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
248 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 7 of 10

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

Z-1406-2019
Recall number
Z-1406-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
1,069 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 8 of 10

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

Z-1407-2019
Recall number
Z-1407-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
888 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 9 of 10

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

Z-1408-2019
Recall number
Z-1408-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
76 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

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).

Distribution pattern

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.

device · product 10 of 10

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

Z-1409-2019
Recall number
Z-1409-2019
Initiated
April 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Remel Inc
Quantity
27 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.

Code information

Material Number: R08858; Lot Number (Labeled Expiration Date): 343868 (02/14/2019), 369544 (04/08/2019), 387018 (05/09/2019).

Distribution pattern

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.