Z-1936-2018Class II

MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard...

Name: Z-1936-2018 MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard...
Creator: Medline Industries Inc
Published: 2018-04-24
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2018-04-24 / Terminated / root cause: packaging

FDA source

Medline Industries Inc began a recall of 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... on 2018-04-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1936-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-24
Posted: 2018-05-25
Terminated: 2020-08-04
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
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 extractor de hoja - Oro, REF NC40FBRGS 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.
Product code: GAB Needle, Suturing, Disposable
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.
Root cause tag: packaging
FDA root cause: Package design/selection
Action: Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704.
Quantity in commerce: 2600 units
Distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
Product codes and lots: Lot Numbers: 67016114502 67016124502 67017014501 67017024502 67017064502 67017064503 67017074501 67017074502 67017084502 67017084503 67017104501

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1936-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1931-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1932-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1933-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1934-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1935-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25
Z-1936-2018	Class II	Terminated	Voluntary: Firm initiated	2018-06-06	2018-05-25

Product code GAB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)