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U.S. Department of Health and Human Services

Class 2 Device Recall Medline

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 Class 2 Device Recall Medlinesee related information
Date Initiated by FirmApril 27, 2026
Date PostedJune 12, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2422-2026
Recall Event ID 98951
Product Classification laparoscopy kit - Product Code FDE
ProductMedline convenience kits: ABD PACK DYNJ81673B BARIATRIC DYNJ902515K BARIATRIC + DYNJ904119O BARIATRIC CDS CDS983883J BWNBORO LAP CHOLE PACK-LF DYNJ32836B CCSB KARIN JWIRE LUMPECTOMY DYNJ910459B CHRISTUS CHILDRENS LAP CHOLE DYNJ61165G CUH MINOR PACK-LF DYNJ60095B FREE FLAP CUSTOM PACK B DYNJ82736B FREE NIPPLE GRAFT DYNJ911160B GEN MINOR DYNJ900906L GEN SURG LAPAROSCOPY PACK DYNJ55248F GEN SURG MINOR PACK DYNJ69142F GENERAL LAP DYNJ61475A DYNJT3759 GENERAL LAP PACK DYNJ61515I DYNJT4452 GENERAL LAP PACK-LF DYNJ37208D GENERAL LAPAROSCOPY DYNJ905870G GENERAL LAPAROSCOPY PACK DYNJ17443T DYNJ45263B DYNJT4504 LAP CHOLE DYNJ45664D DYNJ912005 LAP CHOLE PACK DYNJ81695B LAP CHOLE PACK-LF DYNJ0614113C DYNJ0618369V LAP CHOLE PROCEDURE-LF CDS981184D LAP CHOLE RFD DYNJ906302F LAP CHOLE SURGICOUNT DYNJ45531G LAP CHOLE TOTE DYNJ908339F LAP GASTRIC BYPASS CDS CDS860146M LAP GASTRIC PACK DYNJ62065A LAP HERNIA RFD DYNJ906301F LAP PACK DYNJ38871J DYNJ51389A LAPAROSCOPIC CDS920082AC LAPAROSCOPIC PACK DYNJ52605K LAPAROSCOPIC PACK-LF PHS41736G LAPAROSCOPY PACK DYNJT8313 LAPAROSCOPY PACK-LF DYNJ02309D DYNJ0551175T LAPAROSCOPY UM RF DYNJ902324D LAPAROSCOPY-LF DYNJ903241B LAPAROTOMY PACK-LF DYNJ21091O LARGE ABDOMINAL PACK-LF PHS41737D LEX GENERAL LAPAROSCOPY DYNJ900969K MINOR GENERAL PACK DYNJT3884 MINOR PACK-LF DYNJ0105608I MINOR PK DYNJ61335D MINOR PROCEDURE CDS CDS981793G PEDIATRIC MOSES DYNJ58864B PK, GEN-LAPAROSCOPY DYNJ53837B RMC GENERAL LAPAROSCOPIC DYNJ907087C ROBOTIC GENERAL DYNJ906861D SM-GENERAL LAP PACK-LF DYNJ0780078W SMJ GENERAL ABDOMINAL PACK-LF DYNJ25765Q UOFL HOSP GENERAL LAPAROSCOPY DYNJ909321A
Code Information DYNJ81673B UDI-DI 10195327494728 Lot 26AMA776 DYNJ902515K UDI-DI 10195327662608 Lot 25KBO749 DYNJ904119O UDI-DI 10198459073151 Lots 26ABB899 26ABI225 26ABJ235 CDS983883J UDI-DI 10198459429798 Lot 25KBK403 DYNJ32836B UDI-DI 10195327037369 Lot 25LMF151 DYNJ910459B UDI-DI 10198459477409 Lot 26AML096 DYNJ61165G UDI-DI 10198459386701 Lots 25LBO683 26ABE316 DYNJ60095B UDI-DI 10198459413377 Lots 25KBB960 25LBO686 DYNJ82736B UDI-DI 10198459038907 Lot 25LMG794 DYNJ911160B UDI-DI 10198459398001 Lot 26AMB749 DYNJ900906L UDI-DI 10198459408526 Lot 26AMG179 DYNJ55248F UDI-DI 10195327633486 Lot 25KBA350 DYNJ69142F UDI-DI 10198459478499 Lot 25LMF407 DYNJ61475A UDI-DI 10195327605797 Lot 25JBT649 DYNJT3759 UDI-DI 10198459351037 Lot 25KBJ720 DYNJ61515I UDI-DI 10198459542992 Lot 25KBI633 DYNJT4452 UDI-DI 10198459460678 Lot 25JBR785 DYNJ37208D UDI-DI 10195327434182 Lot 25LBJ032 DYNJ905870G UDI-DI 10198459394591 Lots 25JBP623 25LBR135 DYNJ17443T UDI-DI 10195327692971 Lot 25KBJ329 DYNJ45263B UDI-DI 10193489852394 Lot 25KBH088 DYNJT4504 UDI-DI 10198459456701 Lot 25LMI354 DYNJ45664D UDI-DI 10193489898514 Lot 25KBB002 DYNJ912005 UDI-DI 10198459597121 Lot 25KBT433 DYNJ81695B UDI-DI 10198459023453 Lot 25LMJ938 DYNJ0614113C UDI-DI 10198459352539 Lot 25KBC852 DYNJ0618369V UDI-DI 10889942826599 Lot 26BBC627 CDS981184D UDI-DI 10193489324815 Lot 26AMG257 DYNJ906302F UDI-DI 10198459419850 Lot 25KBG656 DYNJ45531G UDI-DI 10195327006037 Lots 25JBR413 25LBN719 26BBD403 DYNJ908339F UDI-DI 10198459409554 Lot 25KBM957 CDS860146M UDI-DI 10195327224547 Lots 25KBK359 26ABG747 26ABQ780 DYNJ62065A UDI-DI 10193489273472 Lot 25LMH990 DYNJ906301F UDI-DI 10198459419843 Lot 25LBA148 DYNJ38871J UDI-DI 10198459240218 Lot 25LMJ264 DYNJ51389A UDI-DI 10889942881222 Lot 25LBR750 CDS920082AC UDI-DI 10198459237324 Lot 25KBR576 DYNJ52605K UDI-DI 10198459254789 Lot 25LMG367 PHS41736G UDI-DI 10198459438745 Lot 25LMG005 DYNJT8313 UDI-DI 10198459697159 Lot 26CBD042 DYNJ02309D UDI-DI 10198459134432 Lot 25LBP128 DYNJ0551175T UDI-DI 10198459533419 Lot 25KBE001 DYNJ902324D UDI-DI 10198459125683 Lot 25KBQ907 DYNJ903241B UDI-DI 10193489818987 Lot 26ABF331 DYNJ21091O UDI-DI 10198459485183 Lots 25KBA313 26CBD177 PHS41737D UDI-DI 10198459438752 Lot 25LMG512 DYNJ900969K UDI-DI 10198459452314 Lot 26ABG612 DYNJT3884 UDI-DI 10198459366840 Lot 25JBX326 DYNJ0105608I UDI-DI 10198459533259 Lots 25KBA344 25KBM306 25LBE190 DYNJ61335D UDI-DI 10195327128586 Lot 25KBA763 CDS981793G UDI-DI 10198459493683 Lot 25KBT360 DYNJ58864B UDI-DI 10198459346965 Lot 25LBP018 DYNJ53837B UDI-DI 10193489209730 Lot 25LBP490 DYNJ907087C UDI-DI 10198459201301 Lot 26AMA102 DYNJ906861D UDI-DI 10198459293702 Lot 26AMC100 DYNJ0780078W UDI-DI 10195327633929 Lots 25JME845 25LMK134 DYNJ25765Q UDI-DI 10198459603679 Lot 25LMG846 DYNJ909321A UDI-DI 10195327545628 Lot 25KBT731
FEI Number 1417592
Recalling Firm/
Manufacturer
Medline Industries, LP
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information ContactHaley Barclay
800-633-5463
Manufacturer Reason
for Recall
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
FDA Determined
Cause 2
Process control
ActionFirm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
Quantity in Commerce49,654 kits total
DistributionUS Nationwide distribution. OUS distribution pending.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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