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Medline Femoral Pack and FEVAR Kits
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MEDICAL DEVICE RECALLMODERATE

Medline Femoral Pack and FEVAR Kits

Medline recalls Femoral Pack and FEVAR kits due to potentially contaminated component.

What to do

If you have a Medline Femoral Pack (SKU DYNJ909393A) or FEVAR kit (SKU DYNJ910295D), stop using it immediately and contact Medline Industries for instructions on returning the product and obtaining a replacement.

Recalled
Listed
Updated
Recall No.
Z-3019-2026
Agency
FDA
Firm
Medline Industries, LP
Recall ID
99507
Status
ONGOING

Why it was recalled

Medline Industries is recalling two convenience kits, the Femoral Pack (SKU DYNJ909393A) and the FEVAR kit (SKU DYNJ910295D), because they contain a component that may be contaminated. The component was recalled by its manufacturer due to potential contamination.

Is mine affected?

This recall covers 14 products. Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Medline convenience kits labeled

ProductLot codeRecall #UDI-DI
as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W; 6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F; 7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C; 8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F; 9) OPEN HEART, Medline Kit SKU DYNJ910947; 10) CV, Medli–Z-3020-202610198459405266, 40198459405267, 10198459791673, 40198459791674, 10198459123542, 40198459123543, 10198459275814, 40198459275815, 10198459275814, 40198459275815, 10198459385605, 40198459385606, 10198459504877, 40198459504878, 10198459168499, 40198459168490, 10198459168499, 40198459168490, 10198459308581, 40198459308582
as25LMF531, 25JML577, 25JBM473, 26DDB085, 26DDA481, 26CDA102, 25KLA074Z-3029-202610198459385636, 40198459385637, 10198459385636, 40198459385637, 10198459539374, 40198459539375, 10198459255069, 40198459255060, 10198459255069, 40198459255060, 10198459255069, 40198459255060, 10198459419614, 40198459419615
as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470G; 6) CV PART 1 AND 2, Medline Kit SKU DYNJ908879G; 7) GENERAL ROBOTIC, Medline Kit SKU DYNJ910178A; 8) AMB GYN LAPAROSCOPY KT, Medline Kit SKU DYNJ910281B; 9) DIEP FLAP, Medline Kit SKU DYNJ910832A; 10) C-SECT–Z-3024-202610198459729614, 40198459729615, 10198459697739, 40198459697730, 10198459697739, 40198459697730, 10198459219221, 40198459219222, 10198459219221, 40198459219222, 10195327076344, 40195327076345, 10195327678562, 40195327678563, 10198459377419, 40198459377410, 10198459320682, 40198459320683, 10198459586385, 40198459586386
as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline Kit SKU DYNJ900203N; 6) GYN LAPAROSCOPY, Medline Kit SKU DYNJ900541Q; 7) ROBOTIC, Medline Kit SKU DYNJ903485K; 8) ROBOTIC GYN, Medline Kit SKU DYNJ905230K; 9) LAPAROSCOPIC GYN AND COLON, Medline Kit SKU DYNJ9060–Z-3025-202610198459521959, 40198459521950, 10198459521959, 40198459521950, 10195327657222, 40195327657223, 10198459289286, 40198459289287, 10198459289286, 40198459289287, 10198459289521, 40198459289522, 10198459289521, 40198459289522, 10198459510144, 40198459510145, 10198459510144, 40198459510145, 10198459602283, 40198459602284
as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S25LLA853Z-3021-202610198459312557, 40198459312558
as: LTP CDS-LF, Medline kit SKU CDS980375M25JBE079Z-3023-202610198459447327, 40198459447328
as26EMF986, 25IBP434, 26BBA665, 25KBR602, 25JBH531, 25KBL876, 25JBS218Z-3028-202610198459794292, 40198459794293, 10195327599461, 40195327599462, 10195327433376, 40195327433377, 10195327433376, 40195327433377, 10195327433376, 40195327433377, 10198459556838, 40198459556839, 10198459556838, 40198459556839
as26AMC355, 25JBR465, 25LMB480, 26FMB173Z-3022-202610198459385421, 40198459385422, 10198459279324, 40198459279325, 10198459255250, 40198459255251, 10198459790591, 40198459790592
Show all 14 products
ProductLot codeRecall #UDI-DI
as25LBR956, 25KBP729, 26EBN087, 25JBK543, 26FMC227, 26DMK551, 26DMB880Z-3027-202610198459385827, 40198459385828, 10198459385827, 40198459385828, 10195327306830, 40195327306831, 10195327306793, 40195327306794, 10198459794285, 40198459794286, 10198459293207, 40198459293208, 10198459293207, 40198459293208
as25ILA297, 26CBT178Z-3019-202610195327613945, 40195327613946, 10198459586477, 40198459586478
as26FMC710, 26DMG417, 25KMI628, 26ABJ549, 26ABI899, 25LBT433Z-3026-202610198459495625, 40198459495626, 10198459495625, 40198459495626, 10198459523946, 40198459523947, 10198459599569, 40198459599560, 10198459599569, 40198459599560, 10198459599569, 40198459599560
as26CLA636, 26DBG173, 26CBT177, 26DBL480, 26CBQ902, 25IBR180, 26ADA465, 25LBU940, 25IBU845, 26ABI051, 25KBH197, 26BBB487, 25IBS529, 26CBM128, 25JBI549, 25IBP079, 25LBC312, 25KBM427, 26DBO888, 26DBF153–10198459729614, 40198459729615, 10198459697739, 40198459697730, 10198459219221, 40198459219222, 10195327076344, 40195327076345, 10195327678562, 40195327678563, 10198459377419, 40198459377410, 10198459320682, 40198459320683, 10198459586385, 40198459586386, 10198459425653, 40198459425654, 10198459302299, 40198459302290, 10198459302329, 40198459302320, 10198459302336, 40198459302337, 10198459326103, 40198459326104, 10198459714511, 40198459714512
as26FBU894, 26BBF959, 25KMH001, 26ABN671, 25JBT511, 26DBT722, 25JBL333, 25KBF320, 25JBS159, 26AMH304, 26AME001, 26ADA977, 25HDB674, 25KBN172, 25KBH190, 25KBE469, 26AMD191, 26DMF990, 25IBP437, 25ILA566, 25KLA664, 26CBS107–10198459521959, 40198459521950, 10195327657222, 40195327657223, 10198459289286, 40198459289287, 10198459289521, 40198459289522, 10198459510144, 40198459510145, 10198459602283, 40198459602284, 10198459255083, 40198459255084, 10198459520532, 40198459520533, 10198459501616, 40198459501617, 10198459556579, 40198459556570, 10198459539886, 40198459539887, 10198459716799, 40198459716790, 10195327609627, 40195327609628, 10195327609733, 40195327609734, 10198459556586, 40198459556587, 10198459611025, 40198459611026
as26FMA487, 26GMA017, 25LMG706, 25JBY147, 25JBR361, 25LMH727, 25JME689, 25JMF804, 25IMG539, 25LLA930, 25LLA516, 25LLA196, 25KLA552, 25KBD555, 25JBS919, 25JBM122, 25KBF034–10198459405266, 40198459405267, 10198459791673, 40198459791674, 10198459123542, 40198459123543, 10198459275814, 40198459275815, 10198459385605, 40198459385606, 10198459504877, 40198459504878, 10198459168499, 40198459168490, 10198459308581, 40198459308582, 10198459208928, 40198459208929, 10198459361616, 40198459361617

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification