Medline Sterile Needle Counter Recall Due to Packaging Seal Creep
Medline is recalling sterile needle counters because packaging seal creep may compromise sterility. The product is used to count surgical sharps.
The agency’s classification
FDA (Devices): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential loss of sterility in a medical device used in surgical procedures, which poses a risk of harm, but no injuries or illnesses are reported in the source text.
Plain-English summary
Medline Industries Inc is recalling 14,208 units of MEDLINE Sterile Needle Counters (reorder code DYNJNC100F). The recall involves specific lot numbers distributed worldwide, including the United States, Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates.
The recall was initiated because the product packaging seal has the potential to experience seal creep. This defect may create gaps in the packaging seals, which could impact the sterility of the needle counters. The product is intended to be used safely and easily to account for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.
No specific instructions for consumers are provided in the source text. The recall is classified as Class II by the FDA.
The recalled product
- Product
- MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F 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…
- Manufacturer
- Medline Industries Inc
- Affected units
- 14,208
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- Lot Numbers: 67016114502
- 67017014501
- 67017024503
- 67017034501
- 67017044504
- 67017054501
- 67017054504
- 67017064503
- 67017074501
- 67017074502
- 67017084502
- 67017094501
- 67017104501
- 67017114501
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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