| Date Initiated by Firm | April 27, 2026 |
| Date Posted | June 12, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2422-2026 |
| Recall Event ID |
98951 |
| Product Classification |
laparoscopy kit - Product Code FDE
|
| Product | Medline 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 Contact | Haley 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 |
| Action | Firm 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 Commerce | 49,654 kits total |
| Distribution | US Nationwide distribution. OUS distribution pending. |
| Total Product Life Cycle | TPLC 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.
|