Limited official informationFDA Medical Device Enforcement ReportsRecall date: Jun 24, 2026

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING...

Full official product description

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837 | Medline convenience kits: DAVINCI MAIN DYNJ908031D | 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 | Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAROSCOPY CDS CDS982371I GYN LAPAROSCOPY CDS #34-RF CDS920099S GYN LAPAROSCOPY PACK DYNJT3887 DYNJT6876 GYN ROBOTIC CDS CDS984228K GYN ROBOTICS DYNJ911843 KIT LABOR DELIVERY TUBAL LIGAT DYKMBNDL165C ROBOTIC LAP CHOLE CDS CDS985442J ROBOTIC PACK DYNJ84725B DYNJ910594B ROBOTIC SURGERY PACK DYNJ53711B ROBOTICS PACK DYNJ83622C UOFL GYN LAPAROSCOPY DYNJ909322B WMC ROBOTIC PACK - LF DYNJ902583O | BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011A

Verification delayed

The last verified facts remain visible. Last successful verification: Aug 3, 2026, 7:43 PM UTC. A temporary source failure does not mean the recall changed.

Official information is incomplete

Missing: action, consumer scope. The page is public for lookup but excluded from search indexing and advertising.

1Is my item affected?

Compare the complete identifiers. Name similarity alone is not a confirmed match.

Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBSI CVC DRESSING CHANGE KIT EBSI1585 PICC DRESSING CHANGE TRAY EBSI1621 PORT ACCESS KIT EBSI1837; Medline convenience kits: DAVINCI MAIN DYNJ908031D; plus 3 additional official variants listed below.

Identifiers to compare

  • UDI 10653160382850
  • UDI 10653160356875
  • UDI 10193489111538
  • UDI 10653160354796
  • UDI 10653160358336
  • UDI 10653160388555
  • UDI 10198459632297
  • UDI 10195327305024
  • UDI 10198459084300
  • UDI 10198459453359
  • UDI 10198459357107
  • UDI 10198459596230
  • UDI 10198459410604
  • UDI 10195327063191
  • UDI 10195327626822
  • UDI 10198459217500
  • UDI 10198459224775
  • UDI 10198459521720
  • UDI 10198459611834
  • UDI 10195327432423
  • UDI 10198459500510
  • UDI 10195327432508
  • UDI 10198459448720
  • UDI 10198459512919
  • UDI 10195327565206
  • UDI 10195327006532
  • UDI 10198459559372
  • UDI 10198459105029
  • UDI 10195327556389
  • UDI 10198459631399
  • UDI 10195327674229
  • UDI 10195327533694
  • UDI 10198459410741
  • UDI 10198459574658
  • UDI 10195327434151
  • UDI 10889942807383
  • UDI 10198459090103
  • UDI 10195327131449
  • UDI 10198459132360
  • UDI 10198459515057
  • UDI 10889942754014
  • UDI 10198459285868
  • UDI 10195327422103
  • UDI 10198459217579
  • UDI 10198459206252
  • UDI 10198459610226
  • UDI 10198459217586
  • UDI 10198459594229
  • UDI 10198459579608
  • UDI 10198459248184
  • UDI 10198459104923
  • UDI 10198459528583
  • UDI 10193489870206
  • UDI 10198459619960
  • UDI 10198459548314
  • UDI 10889942441082
  • UDI 10198459457609
  • UDI 10195327318352
  • UDI 10198459124877
  • UDI 10198459504785
  • UDI 10195327147655
  • UDI 10195327685393
  • UDI 10198459448515
  • UDI 10195327393069
  • UDI 10195327513467
  • UDI 10195327303501
  • UDI 10198459168611
  • UDI 10198459453021
  • UDI 10198459681721
  • UDI 10198459452970
  • UDI 10193489734034
  • UDI 10195327605827
  • UDI 10198459277849
  • UDI 10889942755288
  • UDI 10193489970708
  • UDI 10198459416446
  • UDI 10195327310752
  • UDI 10198459408632
  • UDI 10198459640704
  • UDI 10198459217753
  • UDI 10195327268916
  • UDI 10198459621178
  • UDI 10195327341763
  • UDI 10195327347352
  • UDI 10198459365560
  • UDI 10198459377617
  • UDI 10195327442620
  • UDI 10198459404351
  • UDI 10198459425233
  • UDI 10198459215926
  • UDI 10888277058286
  • UDI 10198459410758
  • UDI 10198459704871
  • UDI 10198459523816
  • UDI 10198459472626
  • UDI 10195327678746
  • UDI 10198459002922
  • UDI 10193489537918
  • UDI 10193489778595
  • UDI 10198459445873
  • UDI 10198459594205
  • UDI 10195327517977
  • UDI 10198459247972
  • UDI 10198459697135
  • UDI 10198459543005
  • UDI 10198459597466
  • UDI 10198459044106
  • UDI 10195327140656
  • UDI 10198459366871
  • UDI 10198459583148
  • UDI 10198459044113
  • UDI 10198459555206
  • UDI 10198459634284
  • UDI 10198459476686
  • UDI 10198459366949
  • UDI 10198459563768
  • UDI 10198459023538
  • UDI 10198459607172
  • UDI 10198459443848
  • UDI 10198459441806
  • UDI 10198459194702
  • UDI 10888277783614
  • Lot 2025103090
  • Lot 2025120890
  • Lot 2025110690
  • Lot 2025102190
  • Lot 2025110390
  • Lot 2025102990
  • Lot 26AMB067
  • Lot 26DBJ301
  • Lot 26DBF966
  • Lot 25KBH623
  • Lot 25JBR783
  • Lot 25LBI311
  • Lot 25LMH561
  • Lot 25KBD109
  • Lot 25JBV609
  • Lot 26DBK390
  • Lot 25LBK865
  • Lot 25LBD958
  • Lot 26AMB027
  • Lot 25LBC027
  • Lot 26AMH337
  • Lot 26BBR233
  • Lot 26CBC179
  • Lot 25KMC466
  • Lot 26AMG182
  • Lot 25LBO306
  • Lot 25KBI658
  • Lot 25JBX146
  • Lot 25KBG081
  • Lot 25LBN779
  • Lot 25KBJ623
  • Lot 25LMK166
  • Lot 25JBA211
  • Lot 25LMH296
  • Lot 25JBT703
  • Lot 25LBO695
  • Lot 25JBS479
  • Lot 25KBJ559
  • Lot 25JBX052
  • Lot 25JBV938
  • Lot 26CBQ083
  • Lot 25LMJ639
  • Lot 25JBU940
  • Lot 26CBS964
  • Lot 25LBA302
  • Lot 26AMJ169
  • Lot 25KBR022
  • Lot 25LMJ127
  • Lot 25LBE987
  • Lot 26AMA067
  • Lot 25LBR764
  • Lot 25JBT916
  • Lot 25JBX122
  • Lot 25LBQ608
  • Lot 25KBJ908
  • Lot 25LBP985
  • Lot 25KBK189
  • Lot 25JMF339
  • Lot 26CBC852
  • Lot 26AMD592
  • Lot 25KBT474
  • Lot 25JBS464
  • Lot 25LMJ294
  • Lot 25KBM844
  • Lot 25LBQ039
  • Lot 25LMB980
  • Lot 25KBG661
  • Lot 25LBD928
  • Lot 26DBK385
  • Lot 25LBA949
  • Lot 25JBY406
  • Lot 25JBA294
  • Lot 25LMH654
  • Lot 25KBM855
  • Lot 25KBL821
  • Lot 25LMH136
  • Lot 25LMI162
  • Lot 25KMB298
  • Lot 26CBO500
  • Lot 25LBC835
  • Lot 25KBH325
  • Lot 26AMA642
  • Lot 26BBD183
  • Lot 26AMA587
  • Lot 25KBG700
  • Lot 25JBA158
  • Lot 26BBC185
  • Lot 25LBQ169
  • Lot 25LBQ110
  • Lot 25LMF333
  • Lot 25LBC215
  • Lot 26BBC139
  • Lot 26CBE087
  • Lot 25LBB787
  • Lot 25KBJ090
  • Lot 25KBC275
  • Lot 25KBG639
  • Lot 25LMJ893
  • Lot 25LMH863
  • Lot 25KBU092
  • Lot 25LMH707
  • Lot 25LBB534
  • Lot 25KBM585
  • Lot 26CBD040
  • Lot 25JBV094
  • Lot 25LBE810
  • Lot 25KBH343
  • Lot 25KBO172
  • Lot 25JBX564
  • Lot 25KBM646
  • Lot 26ABF608
  • Lot 25LBC203
  • Lot 25LBR024
  • Lot 25JBT926
  • Lot 25JBA329
  • Lot 25KBJ104
  • Lot 25KBF929
  • Lot 25LBR740
  • Lot 25LBD961
  • Lot 25LBC041
  • Lot 25LBB738
  • Lot 25KBB849

5 official variants

Affected variants from the official event record
Product or modelCodes and lotsQuantityRecall number
Medline convenience kits: CMH CENTRAL LINE DRESSING CHANGE KIT EBSI1705A CVC/PICC/MIDLINE DRESSING CHANGE KIT EBSI1057A DIALYSIS DRESSING CHANGE EBSI1498 EBS...EBSI1705A UDI-DI 10653160382850 Lot 2025103090 EBSI1057A UDI-DI 10653160356875 Lot 2025120890 EBSI1498 UDI-DI 10193489111538 Lot 2025110690 EBSI1585 UDI-DI 10653160354796 Lot 2025102190 EBSI1621 UDI-DI 10653160358336 Lot 2025110390 EBSI1837 UDI-DI 10653160388555 Lot 202510299049,654 kits totalZ-2438-2026
Medline convenience kits: DAVINCI MAIN DYNJ908031DDYNJ908031D UDI-DI 10198459632297 lot 26AMB06749,654 kits totalZ-2434-2026
Medline convenience kits: ACD DYNJ904999J ACDF DYNJ907336B DYNJ910821A ACDF PACK DYNJ81098C ACL DYNJ911996 ACL ACCESSORY PACK DYNJ86584B ACL- LF DYNJ905281B...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 25LMH70749,654 kits totalZ-2436-2026
Medline convenience kits: DAVINCI DYNJ905836D DAVINCI-LF DYNJ905293I GENERAL ROBOTICS PACK DYNJT8308 GYN LAP CDS860087Q GYN LAPAROSCOPY DYNJ910084C GYN LAPAR...DYNJ905836D UDI-DI 10195327517977 Lot 25LBB534 DYNJ905293I UDI-DI 10198459247972 Lot 25KBM585 DYNJT8308 UDI-DI 10198459697135 Lot 26CBD040 CDS860087Q UDI-DI 10198459543005 Lots 25JBV094 25LBP061 DYNJ910084C UDI-DI 10198459597466 Lot 25LBE810 CDS982371I UDI-DI 10198459044106 Lots 25KBH343 26CBN241 CDS920099S UDI-DI 10195327140656 Lot 25KBO172 DYNJT3887 UDI-DI 10198459366871 Lot 25JBX564 DYNJT6876 UDI-DI 10198459583148 Lot 25KBM646 CDS984228K UDI-DI 10198459044113 Lot 26ABF608 DYNJ911843 UDI-DI 10198459555206 Lot 25LBC203 DYKMBNDL165C UDI-DI 10198459634284 Lot 25LBR024 CDS985442J UDI-DI 10198459476686 Lot 25JBT926 DYNJ84725B UDI-DI 10198459366949 Lot 25JBA329 DYNJ910594B UDI-DI 10198459563768 Lot 25KBJ104 DYNJ53711B UDI-DI 10198459023538 Lots 25KBF929 25LBB875 DYNJ83622C UDI-DI 10198459607172 Lots 25LBR740 26CBJ460 DYNJ909322B UDI-DI 10198459443848 Lot 25LBD961 DYNJ902583O UDI-DI 10198459441806 Lot 25LBC04149,654 kits totalZ-2431-2026
BLOCK TRAY DYNJRA2119A INDWELLING NERVE BLOCK DYNJRA1011ADYNJRA2119A UDI-DI 10198459194702 lot 25LBB738 DYNJRA1011A UDI-DI 10888277783614 lots 25KBB849 25LBB73449,654 kits totalZ-2416-2026

2What is the risk?

The agency's statement is shown without a site-authored severity score.

Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.

Agency classification: Class II

3What should I do?

Only instructions associated with this recall event qualify as an action.

Consumer action is not available in the associated official record. The site does not infer or generate a replacement.

Verify on the official source

The linked agency record controls if any information differs.

Official evidence

Official scope

Distribution reported by the agency

US Nationwide distribution. OUS distribution pending.

Distribution is context, not a confirmed item match. Compare the model, lot, UPC, NDC, or serial number above.

Material change history

  • : affectedSummary changed in the official record.
  • : affectedSummary changed in the official record.