Food, drugs, devices › Remel, Inc
Device recall: Campy CVA Medium 100/PK, R01272
FDA enforcement event 98403 is a device recall by Remel, Inc of Lenexa, KS, initiated 5 Feb 2026 and classified Class II, with 1 product record.
FDA defines Class II as 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. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Remel, Inc has 50 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Remel, Inc, Lenexa, KS.
Reason for recall
"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."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1474-2026 | Campy CVA Medium 100/PK, R01272 | 97 | Class II | Ongoing | 4 Mar 2026 |
Context
Other enforcement events for Remel, Inc
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of AZ, CO, IL, NJ, OH, TN, WA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.