The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1068-2019·Announced 2019-04-03

Medical Action Industries Recalls Laparotomy Sponges Due to Sterility Concerns

Medical Action Industries is recalling specific lots of laparotomy sponges due to a potential lack of sterility assurance. The affected products were distributed nationwide and to Canada and Saudi Arabia.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential lack of sterility assurance in a medical device, which poses a risk of harm even though no injuries have been reported.

Plain-English summary

Medical Action Industries Inc is recalling specific model numbers of Laparotomy Sponges. The recall is due to a potential lack of sterility assurance in the affected products. The recall covers 228,300 packs, with each pack containing 5 units.

The affected products include various sizes and configurations of laparotomy sponges, such as Lap 18X18 XR, Lap 4X18 XR, and Lap 12X12 XR. Specific lot numbers and expiration dates are listed in the agency's recall record. The products were distributed nationwide to numerous US states, as well as to Canada and Saudi Arabia.

Healthcare facilities and consumers should check their inventory for the specific model numbers and lot numbers listed in the recall. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No illnesses or injuries have been reported in connection with this recall.

The recalled product

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…
Manufacturer
Medical Action Industries Inc
Category
Medical Device — Surgical Sponges
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. Model Number (Lot Number
  • Expiration Date): 300 (000252968
  • 11/08/2022)
  • 450 (1808JK318A
  • 08/30/2023)
  • 450 (1807JK318A
  • 07/20/2023)
  • SM40018 (1807JK323A
  • V300 (0000253083
  • 11/12/2022)
  • 2. Model Number (Lot Number
  • Expiration Date): 400 (1808JK301B
  • 400 (1807JK301A
  • 404 (1808JK306A
  • 08/20/2023)
  • V400 (1807JK319A
  • V450 (1808JK320A
  • V450 (1808JK320B
  • 3. Model Number (Lot Number
  • Expiration Date): 402 (1808JK304B

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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