| Date Initiated by Firm | April 27, 2026 |
| Date Posted | June 12, 2026 |
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-2436-2026 |
| Recall Event ID |
98951 |
| Product Classification |
Orthopedic tray - Product Code OJH
|
| Product | Medline convenience kits:
ACD
DYNJ904999J
ACDF
DYNJ907336B
DYNJ910821A
ACDF PACK
DYNJ81098C
ACL
DYNJ911996
ACL ACCESSORY PACK
DYNJ86584B
ACL- LF
DYNJ905281B
ACL PACK
DYNJ67271A
ALIF
DYNJ904848L
ANTERIOR CERVICAL
DYNJ901355J
ARTHROSCOPY
DYNJ908193B
ARTHROSCOPY PACK-LF
DYNJ42963M
DYNJ52268B
ARTHROSCOPY SHOULDER
DYNJ908684A
BACK CDS-LF
CDS983364G
BACK PACK
DYNJT4339
CDH SPINE PACK
DYNJ908828D
CERVICAL CDS
DYNJ903477J
CMC ORTHO BACK TRAY
SYNJ10272B
CRANIOTOMY
DYNJ911853
CRANIOTOMY ROOSEVELT PACK
DYNJ58358F
CUSTOM HAND PACK-LF
DYNJ0537135V
CUSTOM SPINAL PACK
DYNJT7544
DISCECTOMY PACK
DYNJ86770
DJ ORTHO SPINE
DYNJ48980M
EXTREMITY PACK-LF
DYNJT4161
FOOT PACK
DYNJ53179D
GENERAL ORTHO-ACNW
DYNJ84891
GILMORE SHOULDER SCOPE PACK
DYNJ58002
GV LUMBAR LAMINECTOMY PK
DYNJ46938L
HAND PACK
DYNJ63113B
DYNJ69662A
DYNJT5855
HAND-LF
DYNJ903263B
KIT LAMINECTOMY
DYNJ908806C
KNEE ARTHROSCOPY
DYNJ902056C
DYNJ904846I
KNEE ARTHROSCOPY-LF
DYNJ905871F
KNEE SCOPE
DYNJ906986G
LAMINECTOMY
DYNJ904847K
DYNJ909505D
LAMINECTOMY CDS
CDS983115K
LAMINECTOMY CERVICAL DISC-LF
DYNJ905286G
LAMINECTOMY NEURO PACK
DYNJ58356F
LAMINECTOMY SPINE
DYNJ904139L
LOWER EXTREMITY PACK
DYNJ63114C
LUMBAR CERVICAL PACK-LF
DYNJ0101088G
LUMBAR LAMI
DYNJ905020J
LUMBAR LAMINECTOMY
DYNJ53707
LUMBAR LAMINECTOMY PACK
DYNJT4386
MAIN/LAMINECTOMY PACK-LF
DYNJ0565499AN
NJ SPINE SPECIALIST PACK
DYNJ58706F
OHOW SPINE-BACK PACK
DYNJ910097A
ORTHO NECK CDS-LF
CDS983134C
ORTHO PACK-LF
DYNJ37202G
ORTHO SPINE
DYNJ40221G
OSC BEACH CHAIR SHOULDER-LF
DYNJ905282C
PACC PETRIE ACL ADD ON PACK-LF
DYNJ58290D
PACK,ARTHROSCOPY ASC
DYNJ65484A
PACK,POSTERIOR SPINAL FUSION
DYNJ906892B
PAD LATERAL SPINE
DYNJ902158L
DYNJ902158M
PAD POSTERIOR SPINE
DYNJ902142L
PK-SPINE
DYNJ58259A
PODIATRY PACK
DYNJ62288D
POST SPINE PACK
DYNJ20509R
POSTERIOR SPINAL FUSION
DYNJ903250B
RFT ARTHROSCOPY PACK
DYNJ43956C
RFT SHOULDER PACK-NOBLE
DYNJ36331D
SA SHOULDER #2 BORDEN
DYNJ56501A
SHOULDER
DYNJ900893M
DYNJ904184I
SHOULDER ARTHROSCOPY
DYNJ904842G
SHOULDER PACK
DYNJ83483
SHOULDER PACK-LF
DYNJ42973N
SHOULDER SCOPE PACK NTX
DYNJ68399C
SPINAL PACK
DYNJ49692G
SPINE
DYNJ910451A
SPINE PACK
DYNJ20147O
DYNJ84971
DYNJ86044A
DYNJ86308C
DYNJ88917
DYNJS3069
DYNJT4163
DYNJT8396
ST CHARLES TOTAL HIP
DYNJ909593C
TOTAL HIP
DYNJ910906D
TOTAL HIP PACK
DYNJ64156B
TOTAL JOINT
DYNJ904186G
TOTAL KNEE PACK
DYNJ60967
DYNJ61409A
WMC ORTHO SPINE WMC-LF
DYNJ902528M
XLIF
DYNJ910795B |
| Code Information |
DYNJ904999J
UDI-DI 10195327305024
lot 26DBJ301
DYNJ907336B
UDI-DI 10198459084300
lot 26DBF966
DYNJ910821A
UDI-DI 10198459453359
lots
25KBH623
26BBL877
26BBM089
DYNJ81098C
UDI-DI 10198459357107
lots
25JBR783
25KBD860
DYNJ911996
UDI-DI 10198459596230
lots
25LBI311
25LBV123
26ABN955
DYNJ86584B
UDI-DI 10198459410604
lot
25LMH561
DYNJ905281B
UDI-DI 10195327063191
lot 25KBD109
DYNJ67271A
UDI-DI 10195327626822
lot 25JBV609
DYNJ904848L
UDI-DI 10198459217500
lot 26DBK390
DYNJ901355J
UDI-DI 10198459224775
lot 25LBK865
DYNJ908193B
UDI-DI 10198459521720
lot 25LBD958
DYNJ42963M
UDI-DI 10198459611834
lot 26AMB027
DYNJ52268B
UDI-DI 10195327432423
lots
25LBC027
26CBA143
DYNJ908684A
UDI-DI 10198459500510
lot 26AMH337
CDS983364G
UDI-DI 10195327432508
lot 26BBR233
DYNJT4339
UDI-DI 10198459448720
lot 26CBC179
DYNJ908828D
UDI-DI 10198459512919
lots
25KMC466
26AMG065
DYNJ903477J
UDI-DI 10195327565206
lots
26AMG182
26AMG272
SYNJ10272B
UDI-DI 10195327006532
lot 25LBO306
DYNJ911853
UDI-DI 10198459559372
lot 25KBI658
DYNJ58358F
UDI-DI 10198459105029
lots
25JBX146
25LBP519
DYNJ0537135V
UDI-DI 10195327556389
lots
25KBG081
25LBP178
26BBC915
DYNJT7544
UDI-DI 10198459631399
lots 25LBN779
DYNJ86770
UDI-DI 10195327674229
lot 25KBJ623
DYNJ48980M
UDI-DI 10195327533694
lot 25LMK166
DYNJT4161
UDI-DI 10198459410741
lot 25JBA211
DYNJ53179D
UDI-DI 10198459574658
lot 25LMH296
DYNJ84891
UDI-DI 10195327434151
lot 25JBT703
DYNJ58002
UDI-DI 10889942807383
lot 25LBO695
DYNJ46938L
UDI-DI 10198459090103
lot 25JBS479
DYNJ63113B
UDI-DI 10195327131449
lot 25KBJ559
DYNJ69662A
UDI-DI 10198459132360
lot 25JBX052
DYNJT5855
UDI-DI 10198459515057
lots
25JBV938
25LBO691
DYNJ903263B
UDI-DI 10889942754014
lot 26CBQ083
DYNJ908806C
UDI-DI 10198459285868
lot 25LMJ639
DYNJ902056C
UDI-DI 10195327422103
lots
25JBU940
25LBR965
DYNJ904846I
UDI-DI 10198459217579
lot 26CBS964
DYNJ905871F
UDI-DI 10198459206252
lot 25LBA302
DYNJ906986G
UDI-DI 10198459610226
lot 26AMJ169
DYNJ904847K
UDI-DI 10198459217586
lot 25KBR022
DYNJ909505D
UDI-DI 10198459594229
lot 25LMJ127
CDS983115K
UDI-DI 10198459579608
lot 25LBE987
DYNJ905286G
UDI-DI 10198459248184
lots
26AMA067
26AMH307
DYNJ58356F
UDI-DI 10198459104923
lot
25LBR764
DYNJ904139L
UDI-DI 10198459528583
lot 25JBT916
DYNJ63114C
UDI-DI 10193489870206
lot 25JBX122
DYNJ0101088G
UDI-DI 10198459619960
lot 25LBQ608
DYNJ905020J
UDI-DI 10198459548314
lot 25KBJ908
DYNJ53707
UDI-DI 10889942441082
lots
25LBP985
26CBR371
DYNJT4386
UDI-DI 10198459457609
lot 25KBK189
DYNJ0565499AN
UDI-DI 10195327318352
lot 25JMF339
DYNJ58706F
UDI-DI 10198459124877
lot 26CBC852
DYNJ910097A
UDI-DI 10198459504785
lot 26AMD592
CDS983134C
UDI-DI 10195327147655
lot 25KBT474
DYNJ37202G
UDI-DI 10195327685393
lots
25JBS464
25LBR525
DYNJ40221G
UDI-DI 10198459448515
lot 25LMJ294
DYNJ905282C
UDI-DI 10195327393069
lot 25KBM844
DYNJ58290D
UDI-DI 10195327513467
lot 25LBQ039
DYNJ65484A
UDI-DI 10195327303501
lot 25LMB980
DYNJ906892B
UDI-DI 10198459168611
lots
25KBG661
26BBC906
DYNJ902158L
UDI-DI 10198459453021
lot 25LBD928
DYNJ902158M
UDI-DI 10198459681721
lot 26DBK385
DYNJ902142L
UDI-DI 10198459452970
lot 25LBA949
DYNJ58259A
UDI-DI 10193489734034
lots
25JBY406
25LBM865
DYNJ62288D
UDI-DI 10195327605827
lots
25JBA294
25KBB258
DYNJ20509R
UDI-DI 10198459277849
lots
25LMH654
26AMB105
DYNJ903250B
UDI-DI 10889942755288
lot 25KBM855
DYNJ43956C
UDI-DI 10193489970708
lot 25KBL821
DYNJ36331D
UDI-DI 10198459416446
lot 25LMH136
DYNJ56501A
UDI-DI 10195327310752
lot 25LMI162
DYNJ900893M
UDI-DI 10198459408632
lots
25KMB298
26AMB284
DYNJ904184I
UDI-DI 10198459640704
lot 26CBO500
DYNJ904842G
UDI-DI 10198459217753
lot 25LBC835
DYNJ83483
UDI-DI 10195327268916
lot 25KBH325
DYNJ42973N
UDI-DI 10198459621178
lot 26AMA642
DYNJ68399C
UDI-DI 10195327341763
lot 26BBD183
DYNJ49692G
UDI-DI 10195327347352
lot 26AMA587
DYNJ910451A
UDI-DI 10198459365560
lot
25KBG700
26ABF330
DYNJ20147O
UDI-DI 10198459377617
lot 25JBA158
DYNJ84971
UDI-DI 10195327442620
lot 26BBC185
DYNJ86044A
UDI-DI 10198459404351
lot 25LBQ169
DYNJ86308C
UDI-DI 10198459425233
lot 25LBQ110
DYNJ88917
UDI-DI 10198459215926
lot 25LMF333
DYNJS3069
UDI-DI 10888277058286
lot 25LBC215
DYNJT4163
UDI-DI 10198459410758
lot 26BBC139
DYNJT8396
UDI-DI 10198459704871
lot 26CBE087
DYNJ909593C
UDI-DI 10198459523816
lot 25LBB787
DYNJ910906D
UDI-DI 10198459472626
lot 25KBJ090
DYNJ64156B
UDI-DI 10195327678746
lots
25KBC275
25LBC916
26CBC871
DYNJ904186G
UDI-DI 10198459002922
lots
25KBG639
25LBB568
DYNJ60967
UDI-DI 10193489537918
lot 25LMJ893
DYNJ61409A
UDI-DI 10193489778595
lots
25LMH863
26AMC051
DYNJ902528M
UDI-DI 10198459445873
lot 25KBU092
DYNJ910795B
UDI-DI 10198459594205
lot 25LMH707
|
| 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.
|