Device recall: MEDLINE Sterile* Needle Counter, 100Ct. Double Magnet / Foam Block, reorder: DYNJNC100F Product Usage: A needle…

Class II FDA enforcement event 80017. Recall start date: 24 Apr 2018. Status in the FDA record: Terminated. Termination date: 4 Aug 2020.

Reason for recall, in the words of FDA

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.

Class II, in the words of FDA

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

Medline Industries Inc started this device recall on 24 Apr 2018. The firm address in the FDA record is in Northfield, IL. FDA put the recall in Class II. FDA event 80017 has 6 product records. The first FDA enforcement report date is 6 Jun 2018. The record gives the status Terminated, with the termination date 4 Aug 2020.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

Recalling firm

Medline Industries Inc, Northfield, IL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 80017: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-1931-2018	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 with the surgical site or the patient.	14208 units	Class II	Terminated	6 Jun 2018
Z-1932-2018	MEDLINE Sterile* Needle Counter, 40Ct. Foam Block / Adhesive, reorder: DYNJNC40A 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.	38464 units	Class II	Terminated	6 Jun 2018
Z-1933-2018	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 surgical site or the patient.	220608 units	Class II	Terminated	6 Jun 2018
Z-1934-2018	MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 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…	80200 units	Class II	Terminated	6 Jun 2018
Z-1935-2018	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…	23150 units	Class II	Terminated	6 Jun 2018
Z-1936-2018	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…	2600 units	Class II	Terminated	6 Jun 2018

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2018: 1,074
Share of these events in Class II: 92%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 61

Other events of the firm

Other FDA enforcement events of Medline Industries Inc
Initiated	Product (first record)	Type	Class	Records
21 Jul 2022	Medline CHEST TUBE REORDER NO: DYNJ36762A	Device	Class II	1
8 Nov 2021	Hand Sanitizer Foam (ethyl alcohol), 62% v/v, packaged in a) 1.5 Oz. cans, NDC 53329-970-12; b) 8 Oz. (227 g) cans, NDC	Drug	Class II	1
27 Oct 2021	EVLP Convenience Pack/Kit	Device	Class II	5
6 Aug 2021	NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF 64038301, UPN H965640383011, 3 Valve Manifold, Of	Device	Class II	2
1 Jul 2021	Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, containing expired component NaCl 3000mL Irr	Device	Class II	4
25 May 2021	Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Large Premium Cotton Ovals - two textures soft a	Device	Class II	1
14 May 2021	READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use O	Drug	Class III	1
30 Apr 2021	Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case, Sterile, Rx. Convenience kit used to recov	Device	Class II	1
15 Mar 2021	Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the Stat-Site test strips or KetoSite test car	Device	Class II	1
25 Jan 2021	RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglob	Device	Class II	1

Medline Industries Inc: all 61 events

Official channels

FDA enforcement report Z-1931-2018The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 80017. https://recallregister.com/fda/ii/80017/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates
What quantity of product is in FDA event 80017?: The event has 6 product records. The first record gives this quantity: 14208 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2018 have the same class?: 92% of the 1,074 device events that started in 2018 are in Class II.