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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential loss of sterility due to packaging defects, which is a theoretical risk without reported injuries or illnesses in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medline Industries Inc is recalling 220,608 units of MEDLINE Sterile Needle Counters (40-count foam block/magnet, reorder code DYNJNC40F). The recall is due to a potential issue with the product packaging seal, which may experience "seal creep." This defect can create gaps in the packaging seals, potentially impacting the sterility of the needle counters.
The affected products were distributed worldwide, including the United States, Canada, Saudi Arabia, the Cayman Islands, and the United Arab Emirates. The recall covers specific lot numbers listed in the agency's official record. The needle counters are 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.
Consumers and healthcare facilities should stop using the affected needle counters and contact Medline Industries Inc for further instructions or a replacement. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Magnet, reorder: DYNJNC40F 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…
- Manufacturer
- Medline Industries Inc
- Affected units
- 220,608
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.
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