Lenexa, KS, United States
Remel Inc recalls
22 recalls recorded since 2018, most recently on 3 June 2026. 12 are listed as ongoing. Status and classification are as published by the FDA.
Recalls22
Ongoing (FDA)12
Terminated or completed10
Class I (FDA)1
Ongoing Class II Medical devices
- Recall started
- 3 June 2026
- Reason
- Reduced or no recovery of some strains of Neisseria gonorrhoeae.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2623-2026
- GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Ongoing Class II Medical devices
- Recall started
- 24 March 2026
- Reason
- Products may report incorrect AST results during quality control. Health consequences may include delayed response or the need to change to another antifungal agent if laboratory ignores Quality Control test result.
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1806-2026
- Yeastone Broth, 11ML, 10/BOX YY3462
Ongoing Class II Medical devices
- Recall started
- 5 February 2026
- Reason
- Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- Distribution
- US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1474-2026
- Campy CVA Medium 100/PK, R01272
Ongoing Class II Medical devices
- Recall started
- 12 November 2025
- Reason
- Products may contain contamination, which may result in a darker or brown media color.
- Distribution
- Worldwide - US Nationwide distribution in the states of AK, CA, FL, GA, IA, IL, IN, LA, MA, MD, ME, MI, MN, NE, NY, OH, OK, PA, RI, SD, TN, VA, WA, WI and the countries of Brazil, Canada, China, Cyprus, Finland, Great Britain, Ireland, Moldova, Norway, Singapore.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0585-2026
- 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Ongoing Class II Medical devices
- Recall started
- 11 July 2025
- Reason
- The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2223-2025, Z-2226-2025, Z-2224-2025, Z-2225-2025
- Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
- Blood/MacConkey Biplate 100/PK, Product Number R02049
- Strep Selective II Agar, Product Number R01859
- Blood/EMB, Levine 100/PK, Product Number R02041
Ongoing Class II Medical devices
- Recall started
- 1 May 2025
- Reason
- Product may have an off color affecting perfomance
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1947-2025
- Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
Ongoing Class II Medical devices
- Recall started
- 13 February 2025
- Reason
- Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1201-2025, Z-1200-2025
- remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
- remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Ongoing Class II Medical devices
- Recall started
- 12 February 2025
- Reason
- Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
- Distribution
- Domestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH, PA, TN, TX, WI. International distribution to Canada and the Bahamas.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1395-2025
- Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ
Ongoing Class II Medical devices
- Recall started
- 20 September 2024
- Reason
- A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.
- Distribution
- Distribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was government distribution but no military distribution. Foreign distribution was made to the United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0266-2025
- remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Ongoing Class II Medical devices
- Recall started
- 14 August 2023
- Reason
- On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2531-2023
- remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
Ongoing Class II Medical devices
- Recall started
- 31 May 2023
- Reason
- The test medium may not perform as intended.
- Distribution
- Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2038-2023
- Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In Vitro Diagnostic Use.
Terminated Class I Medical devices
- Recall started
- 20 October 2022
- Terminated
- 30 September 2024
- Reason
- An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0334-2023, Z-0329-2023, Z-0330-2023, Z-0328-2023, Z-0331-2023, Z-0333-2023, Z-0332-2023, Z-0335-2023, Z-0327-2023
- Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 10 January 2022
- Terminated
- 24 July 2026
- Reason
- There are lower than expected MICs for some gram negative species.
- Distribution
- Distribution throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0722-2022
- Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Terminated Class II Medical devices
- Recall started
- 18 June 2021
- Terminated
- 4 August 2023
- Reason
- Out of Specification
- Distribution
- Worldwide distribution - US Nationwide distribution including in the states of AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY, District of Columbia, Hawaii and Puerto Rico. The countries of BERMUD
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2142-2021
- ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Terminated Class II Medical devices
- Recall started
- 22 April 2021
- Terminated
- 8 August 2023
- Reason
- The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
- Distribution
- US Nationwide distribution in the states of AZ, CA, CO, CT, GA, IA, IL, IN, MA, MI, MN, MO, NC, ND, OH, OR, PA, SD, TN, TX, and VA. There was government distribution and no military or foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1561-2021
- Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screening method for primary isolation and presumptive identification of vancomycin-re
Ongoing Class II Medical devices
- Recall started
- 10 March 2021
- Reason
- When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1425-2021, Z-1424-2021
- Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as
- Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualitative procedures by the Clinical and Laboratory Standards Institute (CLSI) as
Terminated Class II Medical devices
- Recall started
- 10 December 2020
- Terminated
- 6 July 2023
- Reason
- The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
- Distribution
- Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0769-2021
- Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Terminated Class II Medical devices
- Recall started
- 17 April 2019
- Terminated
- 21 August 2020
- Reason
- Potential for products to fail performance testing per the Instructions for Use (IFU) starting at 57 days after date of manufacturing. Expiration date is shortened from 7 months to 56 days.
- Distribution
- Worldwide Distribution -US Nationwide distribution to AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, SD, TN, VA, VT, WA, WI, WV, WY, Puerto Rico. International distribution to Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1377-2019, Z-1378-2019, Z-1380-2019, Z-1379-2019
- Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- Thio Med w/Dex, Hemin, Vit K (5ml) 20/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage; Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes
- 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
Terminated Class II Medical devices
- Recall started
- 17 April 2019
- Terminated
- 10 July 2020
- Reason
- 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.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1409-2019, Z-1404-2019, Z-1405-2019, Z-1407-2019, Z-1402-2019, Z-1408-2019, Z-1403-2019, Z-1400-2019, Z-1406-2019, Z-1401-2019
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 4 January 2019
- Terminated
- 17 August 2020
- Reason
- Potential for out of range microbial results
- Distribution
- ...
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1939-2020
- SWIN 2017 database, Model YSW4000
Terminated Class II Medical devices
- Recall started
- 13 August 2018
- Terminated
- 18 June 2019
- Reason
- Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
- Distribution
- US, Canada, Singapore
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-3019-2018, Z-3018-2018, Z-3017-2018
- remel THIOGLYCOLLATE MEDIUM, REF 05152
- remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
- remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
Terminated Class II Medical devices
- Recall started
- 8 December 2017
- Terminated
- 22 July 2020
- Reason
- The serum may fail to agglutinate within the specified minimum reaction time.
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0290-2018
- Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01. Product Usage: Suitable for the use in slide agglutination tests to identify Shigella cultures presumptively for epidemiological and diagno
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.