Medline Needle Counters Recalled for Potential Packaging Seal Creep
Medline Industries is recalling 2,600 units of sterile needle counters because packaging seal creep may compromise sterility.
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 seal creep, which is a theoretical risk without reported illnesses or injuries in the source text, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Medline Industries Inc is recalling 2,600 units of MEDLINE O.R. Necessities(R) STERILE R Needle Counters. The recall involves the Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, reference number NC40FBRGS. The affected lot numbers are 67016114502, 67016124502, 67017014501, 67017024502, 67017064502, 67017064503, 67017074501, 67017074502, 67017084502, 67017084503, and 67017104501.
The recall was initiated because the product packaging seal has the potential to experience seal creep. This defect may result in gaps being created in the seals of the packaging, which may impact the sterility of the Needle Counters. The product is intended to be used safely and easily for accounting for used, disposable surgical sharps during a surgical procedure and does not come in contact with the surgical site or the patient.
The affected products were distributed worldwide, including US Nationwide, Canada, Saudi Arabia, Cayman Island, and the United Arab Emirates. The source text does not specify instructions for consumers or healthcare facilities regarding the disposition of these units.
The recalled product
- Product
- MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con…
- Manufacturer
- Medline Industries Inc
- Affected units
- 2,600
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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