FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
- Recall number
- Z-3092-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline ReNewal Reprocessed Covidien LigaSure Blunt Tip, Sealer/Divider, Nano-Coated, Compatible w/ FT10 37cm FT10 SW Version 4.0.1.15 or lower. Item Number: LF1837CR.
- Status
- Open, Classified
- Initiated
- 2024-05-07
- Posted
- 2024-09-10
- Terminated
- not on file
- Reason
- Potential for an incomplete seal on the packaging tray.
- Root cause
- Under Investigation by firm
- Action
- Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.
- Quantity
- 3,618 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Item Number: LF1837CR. UDI/DI: 20888277680392 (case), 10888277680395 (each). Lot Numbers: 487233, 487315, 487475, 487511, 499861, 499917, 500068, 500138, 500201, 500290, 500341, 500500, 500502, 500522, 500524, 500610, 500614, 500656, 500657, 507286, 507341, 507381, 507382, 507384, 507389, 507390, 507575, 513875, 514206, 514498, 514503, 514611, 514613, 514635, 514636, 514848, 514849, 514850, 514851, 514852, 514853, 514854, 514855, 514856, 515029, 515030, 515031, 515032, 515033, 515034, 515035, 515036, 515037, 515038, 515187, 515188, 515189, 515190, 515191, 515192, 515193, 515194, 515195, 515196, 515197, 515242, 515243, 515244, 515245, 515285, 515286, 515287, 515288, 515338, 515339, 515419, 515420, 515421, 515422, 515423, 515424, 515425, 515426, 515427, 515428, 515429, 515430, 515431, 515432, 515433, 515466, 515467, 515468, 515469, 515470, 515471, 515567, 515673, 515674, 515675, 515676, 515677, 515678, 515679, 515680, 515681, 515682, 515683, 515684, 515685, 515686, 515761, 515763, 515833, 515839, 515949, 515950, 515951, 516078, 516079, 516080, 516081, 516082, 516083, 516084, 516085, 516086, 516089, 516090, 516211, 516212, 516220, 516222, 516223, 516224, 516225, 516257, 516258, 516259, 516260, 516265, 516266, 516268, 516269, 516271, 516272, 516274, 516275, 516277, 516299, 516397, 516506, 516546, 516547, 516548, 516719, 516720, 516724, 516725, 516726, 516727, 516732, 516733, 516747, 516748, 516750, 516753, 516755, 516761, 516762, 516763, 516764, 516765, 516766, 516767, 516769, 516770, 516771, 516772, 516773, 516774, 516775, 516867, 516868, 516871, 516878, 516880, 517095, 517096, 517097, 517209, 517210, 517211, 517212, 517213, 517214, 517215, 517246, 517249, 517429, 517430, 517431, 517433, 517435, 517436, 517694, 517695, 517696, 517697, 517698, 517699, 517700, 517702, 517703, 517704, 517705, 517779, 517780, 517781, 517782, 517783, 517784, 517785, 517786, 517932, 518016, 518017, 518019, 518020, 518021, 518022, 518023, 518024, 518025, 518026, 518027, 518028, 518029, 518150, 518152, 518154, 518155, 518157, 518158, 518289, 518292, 518532, 518533, 518534, 518535, 518536, 518537, 518538, 518539, 518541, 518542, 518621, 518633, 518670, 518819, 518822, 518830.
- 510(k) numbers
- ["K160333"]
- PMA numbers
- not on file
- Product code
- NUJ
- 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