Remel recalls
Remel appears in 86 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-08.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 86 |
|---|---|
| Published | 2013-02-13 to 2026-07-08 |
| By agency | FDA Device (86) |
| By classification | Class II (74), Class I (9), Class III (3) |
| By status | terminated (69), ongoing (17) |
| Distribution named in notices | AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, US, VA, VT, WA, WI |
Recalls
- GC Agar Base (150mm) 10/PK R04030
FDA Device · Class II · 2026-07-08 · Remel
Reason: Reduced or no recovery of some strains of Neisseria gonorrhoeae. - Yeastone Broth, 11ML, 10/BOX YY3462
FDA Device · Class II · 2026-04-22 · Remel
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. - Campy CVA Medium 100/PK, R01272
FDA Device · Class II · 2026-03-04 · Remel
Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. - 1. CAMHB W/LHB, MANUAL, 11ML, 10/BOX YCP112-10 2. BRUCELLA BROTH, 11ML, 10/BOX YT3450
FDA Device · Class II · 2025-12-03 · Remel
Reason: Products may contain contamination, which may result in a darker or brown media color. - Blood Agar,5% Sheep Blood 100/PK, Product Number R01202
FDA Device · Class II · 2025-08-06 · Remel
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. - Blood/MacConkey Biplate 100/PK, Product Number R02049
FDA Device · Class II · 2025-08-06 · Remel
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. - Blood/EMB, Levine 100/PK, Product Number R02041
FDA Device · Class II · 2025-08-06 · Remel
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. - Strep Selective II Agar, Product Number R01859
FDA Device · Class II · 2025-08-06 · Remel
Reason: The products may contain surface and subsurface contamination of Listeria monocytogenes. - Thermo SCIENTIFIC Sensititre Cation Adjusted AutoRead Mueller-Hinton Broth w/ TES w/ Lysed Horse Blood, REF CP11410
FDA Device · Class II · 2025-06-18 · Remel
Reason: Product may have an off color affecting perfomance - Zebra Thermal Barcode Printer GX430t, Model no
FDA Device · Class II · 2025-03-26 · Remel
Reason: Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard. - remel BLOOD AGAR MacCONKEY AGAR BIPLATE, REF R02049, QTY 100, for invitro diagnostic use
FDA Device · Class II · 2025-02-26 · Remel
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. - remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use
FDA Device · Class II · 2025-02-26 · Remel
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. - remel BactiDrop Acridine Orange, REF 21502, 50 per package
FDA Device · Class II · 2024-11-06 · Remel
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. - remel TODD HEWITT W. CNA (LIM BROTH), REF R064810
FDA Device · Class II · 2023-09-20 · Remel
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 - Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033
FDA Device · Class II · 2023-07-05 · Remel
Reason: The test medium may not perform as intended. - Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre HPB1, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre STP7F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
FDA Device · Class I · 2022-12-14 · Remel
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., Morgane… - Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
FDA Device · Class II · 2022-03-16 · Remel
Reason: There are lower than expected MICs for some gram negative species. - ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
FDA Device · Class II · 2021-08-04 · Remel
Reason: Out of Specification - Remel Bile Esculin Azide Agar w/ 6mcg/ml Vancomycin, Product #R01186, 10/package - Product Usage: use in qualitative procedures as a screen…
FDA Device · Class II · 2021-05-19 · Remel
Reason: The media allows growth of E. faecalis ATCC 29212 with blackening of the media. - Remel Haemophilus Test Medium(100mm) 10/PK, REF: R01503 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit…
FDA Device · Class II · 2021-04-21 · Remel
Reason: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure. - Remel Haemophilus Test Medium (150 mm) 10/PK, REF 04033 Remel Haemophilus Test Medium (HTM) is a solid medium recommended for use in qualit…
FDA Device · Class II · 2021-04-21 · Remel
Reason: When tested with H. influenza ATCC 49247 and ATCC 49766 both organisms may exhibit lighter than normal growth making zones difficult to measure. - Remel Blood Agar/MacConkey Agar Bi-Plate, REF: R02049
FDA Device · Class II · 2021-01-20 · Remel
Reason: The blood agar side of the bi-plate may not grow some patient isolates or QC organisms as intended. - SWIN 2017 database, Model YSW4000
FDA Device · Class II · 2020-05-20 · Remel
Reason: Potential for out of range microbial results - 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 culti…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cul…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cultiva…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cultiv…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cu…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 culti…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cultiv…
FDA Device · Class II · 2019-05-29 · Remel
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. - Thio Med w/Dex, Hem, Vit K (7ml) 20/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel
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. - Thio Med w/Dex, Hem, Vit K (5ml) 100/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cul…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cultiv…
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cul…
FDA Device · Class II · 2019-05-29 · Remel
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. - Thio Med w/Dex, Hem, Vit, K (7ml) 100/PK Product Usage
FDA Device · Class II · 2019-05-29 · Remel
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. - 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 cult…
FDA Device · Class II · 2019-05-29 · Remel
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. - remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
FDA Device · Class II · 2018-09-19 · Remel
Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. - 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…
FDA Device · Class II · 2018-09-19 · Remel
Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. - remel THIOGLYCOLLATE MEDIUM, REF 05152
FDA Device · Class II · 2018-09-19 · Remel
Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. - Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum, Ref R30164201 ZH01
FDA Device · Class II · 2018-01-03 · Remel
Reason: The serum may fail to agglutinate within the specified minimum reaction time. - CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres
FDA Device · Class II · 2017-12-13 · Remel
Reason: Product may have incorrect cation information detailed on the product label.