Z-1068-2019Class II

Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20...

Name: Z-1068-2019 Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20...
Creator: Medical Action Industries Inc
Published: 2019-03-01
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2019-03-01 / Terminated / root cause: sterility

FDA source

Medical Action Industries Inc began a recall of Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300... on 2019-03-01. FDA classified it as Class II and gives the reason as "Potential lack of sterility assurance". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1068-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-01
Posted: 2019-03-28
Terminated: 2021-04-06
Recalling firm: Medical Action Industries, Inc. 306
Product: Laparotomy Sponge with the following product description and model numbers: 1. Lap 18X18 XR (5 each/pack, 20 pack/case) - Model Number 300, 450, SM40018, V300; 2. Lap 18X18 XR (5 each/pack, 40 pack/case) - Model Number 400, 404, V400, V450; 3. Lap 18X18 XR w/ring (5 each/pack, 40 pack/case) - Model Number 402; 4. Lap 4X18 XR (5 each/pack, 40 pack/case) - Model Number 407; 5. Lap 12X12 XR (5 each/pack, 40 pack/case) - Model Number 411; 6. Lap 12X12 XR w/ring (5 each/pack, 40 pack/case) - Model Number 412; 7. Lap 8X36 XR (5 each/pack, 40 pack/case) - Model Number 419; 8. Lap 17X26 XR (5 each/pack, 20 pack/case) - Model Number 426;
Product code: GDY Gauze/Sponge, Internal, X-Ray Detectable
Reason for recall: Potential lack of sterility assurance
Root cause tag: sterility
FDA root cause: Under Investigation by firm
Action: Medical Action Industries notified customers on about 03/01/2019, via "URGENT: MEDICAL DEVICE NOTIFICATION OF RECALL." Instructions for end-users included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, complete and return the provided Recall Response Form, and arrange for the return of all affected product on hand. Instructions for distributors included to examine inventory for affected product, remove any affected product and immediately place it in quarantine, notify any customers if affected product was further distributed, complete and return the provided Recall Response Form once all further distributed product is accounted for and those customers have responded, and arrange for the return of all affected product on hand. For replacement product, please contact MAI Customer Service at 1-800-645-7042.
Quantity in commerce: 228,300 packs (5 units/pack)
Distribution: Distributed nationwide to AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WV, WY. Also distributed to Canada and Saudi Arabia.
Product codes and lots: 1. Model Number (Lot Number, Expiration Date): 300 (000252968, 11/08/2022), 450 (1808JK318A, 08/30/2023), 450 (1807JK318A, 07/20/2023), SM40018 (1807JK323A, 07/20/2023), V300 (0000253083, 11/12/2022); 2. Model Number (Lot Number, Expiration Date): 400 (1808JK301B, 08/30/2023), 400 (1807JK301A, 07/20/2023), 404 (1808JK306A, 08/20/2023), V400 (1807JK319A, 07/20/2023), V450 (1808JK320A, 08/20/2023), V450 (1808JK320B, 08/30/2023); 3. Model Number (Lot Number, Expiration Date): 402 (1808JK304B, 08/30/2023), 402 (1808JK304A, 08/20/2023); 4. Model Number (Lot Number, Expiration Date): 407 (1808JK308A, 08/20/2023), 407 (1807JK308A, 07/20/2023); 5.Model Number (Lot Number, Expiration Date): 411 (1808JK311A, 08/20/2023), 411 (1808JK311B, 08/30/2023); 6. Model Number (Lot Number, Expiration Date): 412 (1808JK312B, 08/30/2023), 412 (1807JK312A, 07/20/2023), 412 (1808JK312A, 08/20/2023); 7. Model Number (Lot Number, Expiration Date): 419 (1807JK313A, 07/20/2023); 8. Model Number (Lot Number, Expiration Date): 426 (1808JK316B, 08/30/2023), 426 (1808JK316A, 08/20/2023);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1068-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1068-2019	Class II	Terminated	Voluntary: Firm initiated	2019-04-03	2019-03-28

Product code GDY

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)