FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI
- Recall number
- Z-1094-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Sterile Procedural Trays, labeled as the following: a. CELEBRATION ROBOTIC CDS b. DAVINCI CDS UCC-LF c. ROBOTICS PACK-LF d. ROBOTICS PACK-LF e. ROBOTIC PACK f. PELVISCOPY PACK-LF g. CUSTOM LITHOTOMY ROBOT PACK h. PERI GYN PACK i. ROBOTICS PACK j. LAP HYSTO PACK k. PK, ROBOTICS-ACCESSORY l. OBS PACK m. LAPAROSCOPY/D&C PACK n. PERI GYN RECTAL PACK o. TVT p. DAVINCI DT-LF q. ROBOTICS SI
- Status
- Open, Classified
- Initiated
- 2022-11-17
- Posted
- 2023-02-06
- Terminated
- not on file
- Reason
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Root cause
- Device Design
- Action
- Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.
- Quantity
- 1,212 cases (2,101 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Lot, serial or model codes
- a. CELEBRATION ROBOTIC CDS, Item Number: CDS983612C, Case UDI/GTIN: 40884389768687, Unit UDI/GTIN: 10884389768686, Lot Number: 22KBE707,22JBX839,22JBX843; b. DAVINCI CDS UCC-LF, Item Number: CDS984663G, Case UDI/GTIN: 40193489323772, Unit UDI/GTIN: 10193489323771, Lot Number: 22JBX614; c. ROBOTICS PACK-LF, Item Number: DYNJ0038258B, Case UDI/GTIN: 40889942902089, Unit UDI/GTIN: 10889942902088, Lot Number: 22IBO524,22HBV626,22HBV627; d. ROBOTICS PACK-LF, Item Number: DYNJ0046667A, Case UDI/GTIN: 40889942160397, Unit UDI/GTIN: 10889942160396, Lot Number: 22JMA806,22IMC899; e. ROBOTIC PACK, Item Number: DYNJ04135B, Case UDI/GTIN: 40888277893536, Unit UDI/GTIN: 10888277893535, Lot Number: 22JBX625,22IBE470; f. PELVISCOPY PACK-LF, Item Number: DYNJ0843760G, Case UDI/GTIN: 40193489899161, Unit UDI/GTIN: 10193489899160, Lot Number: 22IDC034; g. CUSTOM LITHOTOMY ROBOT PACK, Item Number: DYNJ35094C, Case UDI/GTIN: 40889942764991, Unit UDI/GTIN: 10889942764990, Lot Number: 22IBR203; h. PERI GYN PACK, Item Number: DYNJ39021B, Case UDI/GTIN: 40195327191048, Unit UDI/GTIN: 10195327191047, Lot Number: 22JBI763,22IBJ622; i. ROBOTICS PACK, Item Number: DYNJ42016B, Case UDI/GTIN: 40888277938312, Unit UDI/GTIN: 10888277938311, Lot Number: 22JBQ809,22IBG293; j. LAP HYSTO PACK, Item Number: DYNJ43888, Case UDI/GTIN: 40888277073273, Unit UDI/GTIN: 10888277073272, Lot Number: 22JBC458; k. PK, ROBOTICS-ACCESSORY, Item Number: DYNJ52985F, Case UDI/GTIN: 40193489215824, Unit UDI/GTIN: 10193489215823, Lot Number: 22IBK173,22IBK797,22HBG975; l. OBS PACK, Item Number: DYNJ65258B, Case UDI/GTIN: 40193489829496, Unit UDI/GTIN: 10193489829495, Lot Number: 22IBD122; m. LAPAROSCOPY/D&C PACK, Item Number: DYNJ67569A, Case UDI/GTIN: 40195327191529, Unit UDI/GTIN: 10195327191528, Lot Number: 22JBQ481; n. PERI GYN RECTAL PACK, Item Number: DYNJ82556, Case UDI/GTIN: 40195327198269, Unit UDI/GTIN: 10195327198268, Lot Number: 22IBO110; o. TVT, Item Number: DYNJ900506B, Case UDI/GTIN: 40889942576518, Unit UDI/GTIN: 10889942576517, Lot Number: 22IBV025; p. DAVINCI DT-LF, Item Number: DYNJ900569G, Case UDI/GTIN: 40193489861434, Unit UDI/GTIN: 10193489861433, Lot Number: 22JBB568; q. ROBOTICS SI, Item Number: DYNJ902659D, Case UDI/GTIN: 40889942692416, Unit UDI/GTIN: 10889942692415, Lot Number: 22IBG173,22IBG174
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OKV
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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