Medical Action Industries Inc: Medical Device Recall in 2019 - (Recall #: Z-1068-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: March 1, 2019

Date Posted: April 3, 2019

Recall Number: Z-1068-2019

Event ID: 82289

Reason for Recall:

Potential lack of sterility assurance

Status: Terminated

Product Quantity: 228,300 packs (5 units/pack)

Code Information:

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);

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated