FDA Medical Device Recalls (openFDA)
Medical Action Industries Inc: Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
- Recall number
- Z-0681-2019
- Recalling firm
- Medical Action Industries Inc
- Product
- Laparotomy Sponge, XR No Loop, Single-Use, Sterile, 18'' x 18'' pre-washed with bands without handles, 5 sponges/pack, 40 packs/case. X-Ray Detectable, 1 Non-Absorbent outer wrap. intended use: Laparotomy sponges are intended for use inside the body, surgical incision, or for application to internal organs or structure to control bleeding, absorb fluid, or protect organs or structures from abrasions, drying, or contamination.
- Status
- Terminated
- Initiated
- 2018-11-27
- Posted
- not on file
- Terminated
- 2019-02-08
- Reason
- Potential compromise of product sterility due to breach of sterile barrier.
- Root cause
- Under Investigation by firm
- Action
- Medical Action Industries notified customers on about 11/27/2018 via "URGENT MEDICAL DEVICE NOTICE OF RECALL" Letter. Consignees were instructed to immediately examine inventory, quarantine all affected product, notify customers if the affected product was further distributed, and complete and return the recall response form. For consignees with affected product in inventory, Medical Action Industries will issue a Returned Materials Authorization (RMA) to return affected product.
- Quantity
- 13 cases (2,600 sponges)
- Distribution
- Devices were distributed in 5 U.S states: MN, WA, NY, MA and MI. No product was distributed outside of the US.
- Lot, serial or model codes
- Model Number: 403, Lot Number: 1806JK305A, Expiration Date: 06/20/2023, UDI (Pack): 10809160000113, UDI (Case): 50809160000111
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDY
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28