Reported Apr 3, 2019 · Terminated

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

Medical Action Industries Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medical Action Industries Inc · 25 Heywood Rd · Arden, NC · 28704-9302

Is this the product you have?

8 of 8 products

Products covered by this recall
Model / numberProduct as published
300Lap 18X18 XR (5 each/pack, 20 pack/case) - , 450, SM40018, V300
400Lap 18X18 XR (5 each/pack, 40 pack/case) - , 404, V400, V450
402Lap 18X18 XR w/ring (5 each/pack, 40 pack/case)
407Lap 4X18 XR (5 each/pack, 40 pack/case)
411Lap 12X12 XR (5 each/pack, 40 pack/case)
412Lap 12X12 XR w/ring (5 each/pack, 40 pack/case)
419Lap 8X36 XR (5 each/pack, 40 pack/case)
426Lap 17X26 XR (5 each/pack, 20 pack/case)
Lot codes and dates

7 of 7 products

Products covered by this recall
#Product as published
1Model 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)
2Model 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)
3Model Number (Lot Number, Expiration Date): 402 (1808JK304B, 08/30/2023), 402 (1808JK304A, 08/20/2023)
4Model 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)
5Model Number (Lot Number, Expiration Date): 412 (1808JK312B, 08/30/2023), 412 (1807JK312A, 07/20/2023), 412 (1808JK312A, 08/20/2023)
6Model Number (Lot Number, Expiration Date): 419 (1807JK313A, 07/20/2023)
7Model Number (Lot Number, Expiration Date): 426 (1808JK316B, 08/30/2023), 426 (1808JK316A, 08/20/2023)
Amount recalled
228,300 packs (5 units/pack)

Where it was sold

Why it was recalled

Potential lack of sterility assurance

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 6, 2021 · Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.