Device recall: Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal…

Class II FDA enforcement event 82008. Recall start date: 27 Dec 2018. Status in the FDA record: Terminated. Termination date: 29 Jun 2020.

Reason for recall, in the words of FDA

Curity All Purpose Sponges were not sterilized and distributed

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

Cardinal Health 200, LLC started this device recall on 27 Dec 2018. The firm address in the FDA record is in Mansfield, MA. FDA put the recall in Class II. FDA event 82008 has 1 product record. The first FDA enforcement report date is 6 Mar 2019. The record gives the status Terminated, with the termination date 29 Jun 2020.

FDA enforcement report The 1 product record

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 countries of Canada, Colombia.

Recalling firm

Cardinal Health 200, LLC, Mansfield, MA.

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

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

Products

1 product record in the event.

FDA event 82008: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-0957-2019	Curity All Purpose Sponges, Non-woven, 4 Ply, 4" x 4" (10.2 cm x 10.2 cm) Product Code: 8044 - Product Usage: Ideal for applying ointments, prepping, wiping needles, cleaning slides and more Rayon/polyester blend construction Highly absorbent.	10,400 units (13 cases, 800 units/case)	Class II	Terminated	6 Mar 2019

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: 1Median of the firm: 3
Events of the firm on the register: 59

Other events of the firm

Other FDA enforcement events of Cardinal Health 200, LLC
Initiated	Product (first record)	Type	Class	Records
29 Jul 2026	Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY DH , Catal	Device	Class II	12
14 Jul 2026	Cardinal Health Presource Kits: 1) FAT GRAFT ADD KIT , Catalog Number: 21-4720B; 2) TRAY FAT GRAFT ADD , Catalog Number:	Device	Class II	8
2 Mar 2026	Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Wa	Drug	Class I	1
27 Feb 2026	Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777	Device	Class II	1
26 Dec 2025	Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 888857	Device	Class II	1
12 Nov 2025	ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-st	Device	Class II	1
18 Sep 2025	Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC TUBE 10FR 36IN 8888264929E ENFit" SA	Device	Class II	6
13 May 2025	SCD Comfort Knee Length Small, SKU 84021; Kendall SCD Small Comfort sleeves when used with the Kendall SCD Smartflow Con	Device	Class II	3
2 May 2025	Catalog No. 8888160119; Umbilical Vessel Catheter Insertion Tray with 2.5 and 5 French UVCs	Device	Class II	6
8 Nov 2024	Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGH	Device	Class II	10

Cardinal Health 200, LLC: all 59 events

Official channels

FDA enforcement report Z-0957-2019The 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 82008. https://recallregister.com/fda/ii/82008/. 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 countries of Canada, Colombia.
What quantity of product is in FDA event 82008?: The FDA record gives this quantity: 10,400 units (13 cases, 800 units/case)
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.