FDA Medical Device Recalls (openFDA)
Covidien: Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Recall number
- Z-1330-2024
- Recalling firm
- Covidien
- Product
- Situate Laparotomy Sponge, RF and X-ray Detectable, REF: L1818-04P01C-1
- Status
- Open, Classified
- Initiated
- 2024-02-21
- Posted
- 2024-03-21
- Terminated
- not on file
- Reason
- Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this incorrect product wasn't steam pre-treated prior to sterilization, and has no RF tag, which if non-sterile, may lead to infection, tissue trauma, and sepsis, and if in the scannable area, would lead a "CLEAR" display.
- Root cause
- Labeling mix-ups
- Action
- On 2/21/24, recall notices were mailed to customers and distributors who were asked to do the following: 1) Do not use impacted products. 2) Remove, quarantine, and return all unused affected product. 3) This communication needs to be passed to all those who need to be aware within your organization where impacted devices have been transferred, and to any other associated organizations that may be impacted by this action. 4) Complete and return the customer confirmation form to rs.gmbmitgfca@medtronic.com Customers with questions can contact the firm at 800-962-9888 Option 2.
- Quantity
- 755,800
- Distribution
- US Nationwide distribution including in the states of AK, AL, AZ, CA, CO, FL, GA, IA, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, RI, TN, TX, UT, VA, WA, WI, WV.
- Lot, serial or model codes
- UDI-DI: 20884521700953, 10884521700956. Lots: 230504KF, 220903KF, 221102KF
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GDY
- Firm FEI
- 3026612481
- Firm city
- Lafayette
- Firm state
- CO
- 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