Device recall: Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for m

FDA enforcement event 72078 · Class II · initiated 25 Aug 2015 · status Terminated · terminated 1 Aug 2016

DeviceVoluntary: Firm initiated1 product recordWaukegan, IL

FDA enforcement event 72078 is a device recall by Cardinal Health of Waukegan, IL, initiated 25 Aug 2015 and classified Class II, with 1 product record.

FDA defines Class II as 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. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.

Status: Terminated, terminated 1 Aug 2016. Initiation: voluntary: firm initiated. Cardinal Health has 12 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Cardinal Health, Waukegan, IL.

Reason for recall

"Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20."

Distribution

"Nationwide Distribution."

Product records

Recall number	Product	Quantity	Class	Status	Report date
Z-0133-2016	Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a barrier against potentially infectious materials and other contaminants.	34 cases.	Class II	Terminated	28 Oct 2015

Context

91%of 2015 device events are Class II1,153 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Cardinal Health

Initiated	Product (first record)	Type	Class	Records
1 Nov 2022	Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary dr	Device	Class II	6
2 Nov 2021	SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474	Device	Class II	11
4 Aug 2021	Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indicat	Device	Class I	3
11 Jan 2020	AAMI 3 FABRIC REINFORCEDGown 2XL NS, Item Code 9571NA	Device	Class II	39
20 Jul 2016	BLUE IMPERVIOUS GOWN WITH THUMBHOOKS, X-LARGE. Non-Sterile, Single Use Only, Plastic Non-Surgical Isolation Gown Non-Ste	Device	Class II	1
27 Jun 2016	The 9025TRU Arterial Blood Gas (ABG) Kit is used to obtain arterial blood sampling for pH, Blood Gas, Electrolyte and Me	Device	Class II	1
29 Feb 2016	Gomco Style Circumcision Clamp Trays is an instrument used to compress the foreskin of the penis during circumcision of	Device	Class II	1
23 Dec 2014	Lubricated Intubating Stylet 6FR that is inserted into an endotracheal tube to facilitate intubation. This product is us	Device	Class II	1
2 Oct 2013	Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blister card of 30/10 cards in a corrugated ship	Drug	Class III	1
18 Dec 2012	Needle Counters; 11.5 x 6.5 x 3.3 cm; 20 Count/40 Capacity; Sterile; Removable Numbered Foam Block; Adhesive Area (Cat.	Device	Class II	9

All 12 events for Cardinal Health

Questions and answers

Why was this device recalled?

FDA's record gives the reason for recall as: "Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20."

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. 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.

Where was the product distributed?

FDA's distribution pattern field reads: "Nationwide Distribution."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 1 Aug 2016. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.