MEDLINE O — Class II medical device recall Z-1935-2018
Terminated recall by Medline Industries Inc, reported 2018-06-06, distributed nationwide. The product packaging seal has the potential to experience seal creep. This may result in gaps to be created i
| Recall number | Z-1935-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medline Industries Inc, Northfield, IL, United States |
| Recall initiated | 2018-04-24 |
| Classified | 2018-05-25 |
| Reported by FDA | 2018-06-06 |
| Terminated | 2020-08-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, CA, KY, SA |
| Quantity | 23,150 units |
| Reason classes | sterility, packaging |
| Lot numbers | 67016114502, 67017014501, 67017024502, 67017054501 |
Product
MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 40 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
Reason for recall
The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1935-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.