Remel Inc: 86 FDA recall reports
Every medical device recall the FDA has published for Remel Inc. The fault, and how the agency graded it.
86Reports
9Class I
17Ongoing
2026-07-08Most recent
9 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
Z-2623-2026 · Class II · reported 2026-07-08 · Ongoing
- Why it was recalled
- Reduced or no recovery of some strains of Neisseria gonorrhoeae.
- Product
- GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Singapore, and the United Kingdom.
- How much
- 1573
Yeastone Broth, 11ML, 10/BOX YY3462
Z-1806-2026 · Class II · reported 2026-04-22 · Ongoing
- Why it was recalled
- 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.
- Product
- Yeastone Broth, 11ML, 10/BOX YY3462
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Vietnam, France, Argentina, Qatar, New Zealand, Uruguay, Turkey, Netherlands, Singapore.
- How much
- 2819
Campy CVA Medium 100/PK, R01272
Z-1474-2026 · Class II · reported 2026-03-04 · Ongoing
- Why it was recalled
- Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
- Product
- Campy CVA Medium 100/PK, R01272
- Where it went
- US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA.
- How much
- 97
1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
Z-0585-2026 · Class II · reported 2025-12-03 · Ongoing
- Why it was recalled
- Products may contain contamination, which may result in a darker or brown media color.
- Product
- 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
- Where it went
- 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.
- How much
- 1,000 US, 280 ROW
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
Z-2223-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Product
- Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
- Where it went
- US Nationwide distribution.
- How much
- 1552 units
Blood/MacConkey Biplate 100/PK, Product Number R02049
Z-2226-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Product
- Blood/MacConkey Biplate 100/PK, Product Number R02049
- Where it went
- US Nationwide distribution.
- How much
- 611 untis
Strep Selective II Agar, Product Number R01859
Z-2224-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Product
- Strep Selective II Agar, Product Number R01859
- Where it went
- US Nationwide distribution.
- How much
- 371 units
Blood/EMB, Levine 100/PK, Product Number R02041
Z-2225-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Product
- Blood/EMB, Levine 100/PK, Product Number R02041
- Where it went
- US Nationwide distribution.
- How much
- 750 units
Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP
Z-1947-2025 · Class II · reported 2025-06-18 · Ongoing
- Why it was recalled
- Product may have an off color affecting perfomance
- Product
- Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410; invitro diagnostic device
- Where it went
- Worldwide - US Nationwide distribution in the states of AL, GA, KY, VA and the countries of Canada, UK.
- How much
- 70 units
Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional access
Z-1395-2025 · Class II · reported 2025-03-26 · Ongoing
- Why it was recalled
- Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.
- Product
- 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
- Where it went
- 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.
- How much
- 41
remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
Z-1201-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- 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.
- Product
- remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
- Where it went
- US Nationwide distribution.
- How much
- 316 units
remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
Z-1200-2025 · Class II · reported 2025-02-26 · Ongoing
- Why it was recalled
- 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.
- Product
- remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
- Where it went
- US Nationwide distribution.
- How much
- 787 units
remel BactiDrop Acridine Orange, REF 21502, 50 per package.
Z-0266-2025 · Class II · reported 2024-11-06 · Ongoing
- Why it was recalled
- 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.
- Product
- remel BactiDrop Acridine Orange, REF 21502, 50 per package.
- Where it went
- 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.
- How much
- 29 kits
remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimen
Z-2531-2023 · Class II · reported 2023-09-20 · Ongoing
- Why it was recalled
- 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
- Product
- remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial flora
- Where it went
- US Nationwide Distribution
- How much
- 139 units (13,900 tests)
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100m
Z-2038-2023 · Class II · reported 2023-07-05 · Ongoing
- Why it was recalled
- The test medium may not perform as intended.
- Product
- 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.
- Where it went
- Distribution was made nationwide, including Puerto Rico. There was no foreign or military distribution.
- How much
- 1,296 packs
Class I
Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
Z-0334-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 2656 units
Class I
Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
Z-0329-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 8073 units
Class I
Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
Z-0330-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 665 units
Class I
Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
Z-0328-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 2471 units
Class I
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Z-0331-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 588 units
Class I
Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
Z-0333-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 70 units
Class I
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
Z-0332-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 1647 units
Class I
Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
Z-0335-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 9 units
Class I
Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
Z-0327-2023 · Class I · reported 2022-12-14 · Terminated
- Why it was recalled
- 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.
- Product
- Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
- Where it went
- US Nationwide Distribution
- How much
- 1917 units
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
Z-0722-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- There are lower than expected MICs for some gram negative species.
- Product
- Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
- Where it went
- Distribution throughout the United States.
- How much
- 1210 devices
ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
Z-2142-2021 · Class II · reported 2021-08-04 · Terminated
- Why it was recalled
- Out of Specification
- Product
- ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
- Where it went
- 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 BERMUDA.
- How much
- 327 units
Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qual
Z-1561-2021 · Class II · reported 2021-05-19 · Terminated
- Why it was recalled
- The media allows growth of E. faecalis ATCC 29212 with blackening of the media.
- Product
- 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-resistance enterococci (VRE) from surveillance cultures.
- Where it went
- 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.
- How much
- 91/10-test units
Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid med
Z-1425-2021 · Class II · reported 2021-04-21 · Ongoing
- Why it was recalled
- When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
- Product
- 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 the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
- Where it went
- US Nationwide distribution.
- How much
- 19 units
Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medi
Z-1424-2021 · Class II · reported 2021-04-21 · Ongoing
- Why it was recalled
- When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure.
- Product
- 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 the growth medium for antimicrobial disk diffusion tests with Haemophilus species.
- Where it went
- US Nationwide distribution.
- How much
- 408 units
Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
Z-0769-2021 · Class II · reported 2021-01-20 · Terminated
- Why it was recalled
- The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended.
- Product
- Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
- Where it went
- Distribution in United States - AL, FL, GA, LA MS, NC, SC, TN
- How much
- 637 units
Showing the 30 most recent of 86. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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