CLASS II ONGOING Device recall · Reported 30 Oct 2024 · FDA Enforcement Report
Medline medical procedure convenience kits, labeled as: EYE PACK recalled
Medline Industries LP - Northfield is recalling Medline medical procedure convenience kits, labeled as: EYE PACK, distributed nationwide in the US. The recall was initiated on 4 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0178-2025
- FDA event ID
- 95415
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2024
- FDA classified
- 23 Oct 2024
- Reported
- 30 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Contact Lenses & Eye Devices
Timeline
| 4 Sep 2024 | Recall initiated by company | |
| 23 Oct 2024 | Classified by FDA | +49 days |
| 30 Oct 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24573K; 4) EYE PACK, REF DYNJ30327A; 5) BASIC CATARACT PACK, REF DYNJ36868F; 6) BASIC RETINA PACK, REF DYNJ40811A; 7) OPHTHALMOLOGY PACK CKHA-LF, REF DYNJ41769A; 8) CATARACT PACK WRO-LF, REF DYNJ41861; 9) EYE PACK, REF DYNJ43911; 10) PHACO PACK, REF DYNJ44748I; 11) DR DRUMMOND EYE PACK, REF DYNJ45344G; 12) OPHTHALMIC PACK, REF DYNJ47275A; 13) CATARACT PACK, REF DYNJ49412B; 14) CATARACT PACK, REF DYNJ50948A; 15) CATARACT PACK, REF DYNJ50948A; 16) CATARACT DR MALONE PACK, REF DYNJ51590A; 17) CATARACT DR MALONE PACK, REF DYNJ51590A; 18) CUSTOM EYE TRAY, REF DYNJ51821B; 19) EYE SURGERY PACK, REF DYNJ53097C; 20) CATARACT KIT, REF DYNJ53944; 21) EYE PACK, REF DYNJ54847D; 22) PK, OPHTH-EYE, REF DYNJ55070B; 23) EYE PACK, REF DYNJ55320D; 24) PK, OPHTH-RETINA, REF DYNJ59253B; 25) RETINA PACK, REF DYNJ60515; 26) ASED KIT, REF DYNJ60745D; 27) CATARACT PACK, REF DYNJ61321B; 28) EYE PACK, REF DYNJ61862A; 29) CATARACT PACK DR FREDERICK, REF DYNJ63163; 30) CATARACT DR ESTOPINAL, REF DYNJ63164; 31) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 32) EYE CATARACT (BASIC EYE), REF DYNJ63272C; 33) HMSL EYE PACK, REF DYNJ64537A; 34) EYE PACK, REF DYNJ65271C; 35) CMC ODS OPHTHALMIC PACK, REF DYNJ66832; 36) BASIC CATARACT PACK, REF DYNJ69165D; 37) BASIC CATARACT PACK, REF DYNJ69165D; 38) LIFESPAN VITRECTOMY PACK, REF DYNJ80082; 39) CATARACT PACK WITH NO TUB, REF DYNJ80232; 40) RETINA PACK, REF DYNJ80483; 41) RETINA PACK, REF DYNJ81640; 42) WESTFALL OCCUPLASTY, REF DYNJ81796A; 43) EYE PACK, REF DYNJ83799C; 44) OPHTHALMIC PACK, REF DYNJ85275; 45) CATARACT, REF DYNJ908059A; 46) EYE TRAY 1-LF, REF LLSCAEYE01A; 47) PHACO PACK, REF LYN011PHNHD; 48) PHACO PACK, REF LYN011PHNHD; 49) SPECIALTY BESSER PACK, REF LYN023BPSSD; 50) SPECIALTY BESSER PACK, REF LYN023BPSSD; 51) SPECIALTY BESSER PACK, REF LYN023BPSSD; 52) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 53) BASIC OPHTHALMIC PACK, REF LYN023BSBLB; 54) OPHTHALMIC PACK, REF LYN023OPSOB; 55) CATARACT PACK CLEARSIGHT CTR, REF LYN024CACSB; 56) BASIC CATARACT PACK, REF LYN030BCSDB; 57) CATARACT PACK SEVEN SPRINGS, REF LYN030CPSSA; 58) AIKEN CATARACT PACK II, REF LYN030CTAKG; 59) AIKEN CATARACT PACK II, REF LYN030CTAKG; 60) AIKEN CATARACT PACK II, REF LYN030CTAKG; 61) VA EYE II-LF, REF LYN030VAEYA; 62) VA EYE II-LF, REF LYN030VAEYA; 63) CATARACT PACK, REF LYN035CTSEC; 64) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 65) EYES OF YORK DR BENZ CATARACT, REF LYN037DBEYM; 66) OPHTHALMIC PACK, REF LYN041OPFCC; 67) OPHTHALMIC PACK, REF LYN041OPFCC; 68) OPHTHALMIC PACK, REF LYN041OPFCC; 69) OPHTHALMIC PACK, REF LYN041OPFCC; 70) CATARACT PACK, REF LYN042CPFEG; 71) OPTHALMIC PACK-LF, REF PHS529724000B; 72) CATARACT PACK, REF VAL001CPMEB; 73) CATARACT PACK, REF VAL001CPMEB; 74) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 75) THE SURGERY CENTER CATARACT, REF VAL002CATSG; 76) RETINA PACK PIEDMONT EYE, REF VAL003REPEA; 77) CATARACT PACK, REF VAL009CAAHC; 78) RENAISSANCE CAT PACK, REF VAL009CAREA; 79) CATARACT TENAYA SURGERY CENTER, REF VAL009CATEA; 80) CATARACT PACK, REF VAL009CTSGA; 81) DOUGHERTY LASER VISION- NEW II, REF VAL009EYDLC; 82) RETINA PACK-TRINITY GROUP, REF VAL009RETGA; 83) RENAISSANCE VIT PACK, REF VAL009VIREA; 84) CATARACT PACK APERTURE, REF VAL011CTVAA; 85) OPHTHALMIC PACK, REF VAL022BSOMD; 86) CATARACT PACK - INST OF OKLA, REF VAL024CAIOD; 87) EYE PACK, REF VAL024EYTRB; 88) CATARACT PACK, REF VAL026CTNFC; 89) EYE PACK, REF VAL029EYGSB; 90) INTRAOCULAR PACK, REF VAL031IOGCB; 91) CATARACT, REF VAL035CPAEC; 92) CATARACT PACK 2, REF VAL036CABRD; 93) BRINTON VISION ICL PACK, REF VAL037ICBVG; 94) EYE PACK, REF VAL038BSCID; 95) CATARACT PACK EYECARE CONSULT, REF VAL038CTECB; 96) EYE PACK SC OF SOUTHWOODS, REF VAL041EPSWA; 97) BOOZMAN HOF PACK 2, REF VAL042EYBHC; 98) CATARACT PACK WILD
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Questions about this recall
Why was it recalled?
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Which lots are affected?
1) REF DYNJ19492L, UDI/DI 40195327368587 (each), 10195327368586 (case), Lot Numbers: 24ABE741; 2) REF DYNJ22354L, UDI/DI 40195327239924 (each), 10195327239923 (case), Lot Numbers: 23LBN139; 3) REF DYNJ24573K, UDI/DI 40195327144303 (each), 10195327144302 (case), Lot Numbers: 23KBB931; 4) REF DYNJ30327A, UDI/DI 40193489997089 (each), 10193489997088 (case), Lot Numbers: 24ABB714; 5) REF DYNJ36868F, UDI/DI 40888277897060 (each), 10888277897069 (case), Lot Numbers: 23KBD160; 6) REF DYNJ40811A, UDI/DI 40888277014634 (each), 10888277014633 (case), Lot Numbers: 23KBE584; 7) REF DYNJ41769A, UDI/DI 40888277267825 (each), 10888277267824 (case), Lot Numbers: 23KBB744; 8) REF DYNJ41861, UDI/DI 40888277020741 (each), 10888277020740 (case), Lot Numbers: 23KBB746; 9) REF DYNJ43911, UDI/DI 40888277073617 (each), 10888277073616 (case), Lot Numbers: 23LBQ741; 10) REF DYNJ44748I, UDI/DI 40193489273459 (each), 10193489273458 (case), Lot Numbers: 23LBP074; 11) REF DYNJ45344G, UDI/DI 40195327402922 (each), 10195327402921 (case), Lot Numbers: 23LBU068; 12) REF DYNJ47275A, UDI/DI 40888277571946 (each), 10888277571945 (case), Lot Numbers: 24ABE470; 13) REF DYNJ49412B, UDI/DI 40889942935278 (each), 10889942935277 (case), Lot Numbers: 24ABD256; 14) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 24ABC786; 15) REF DYNJ50948A, UDI/DI 40195327117550 (each), 10195327117559 (case), Lot Numbers: 23KBA350; 16) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers: 23LBN087; 17) REF DYNJ51590A, UDI/DI 40193489721387 (each), 10193489721386 (case), Lot Numbers: 23KBE531; 18) REF DYNJ51821B, UDI/DI 40193489963374 (each), 10193489963373 (case), Lot Numbers: 23KBE568; 19) REF DYNJ53097C, UDI/DI 40889942721376 (each), 10889942721375 (case), Lot Numbers: 24ABC180; 20) REF DYNJ53944, UDI/DI 40889942450689 (each), 10889942450688 (case), Lot Numbers: 23LBR325; 21) REF DYNJ54847D, UDI/DI 40193489266659 (each), 10193489266658 (case), Lot Numbers: 23LBI510; 22) REF DYNJ55070B, UDI/DI 40193489800686 (each), 10193489800685 (case), Lot Numbers: 23LBU001; 23) REF DYNJ55320D, UDI/DI 40195327429219 (each), 10195327429218 (case), Lot Numbers: 24ABD339; 24) REF DYNJ59253B, UDI/DI 40193489269322 (each), 10193489269321 (case), Lot Numbers: 24ABB328; 25) REF DYNJ60515, UDI/DI 40193489510240 (each), 10193489510249 (case), Lot Numbers: 24ABE890; 26) REF DYNJ60745D, UDI/DI 40193489949309 (each), 10193489949308 (case), Lot Numbers: 24ABA754; 27) REF DYNJ61321B, UDI/DI 40193489794411 (each), 10193489794410 (case), Lot Numbers: 23KBF225; 28) REF DYNJ61862A, UDI/DI 40195327216826 (each), 10195327216825 (case), Lot Numbers: 23KBC772; 29) REF DYNJ63163, UDI/DI 40193489721585 (each), 10193489721584 (case), Lot Numbers: 23LBL330; 30) REF DYNJ63164, UDI/DI 40193489721592 (each), 10193489721591 (case), Lot Numbers: 23LBN120; 31) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 24ABC862; 32) REF DYNJ63272C, UDI/DI 40195327532254 (each), 10195327532253 (case), Lot Numbers: 23KBI662; 33) REF DYNJ64537A, UDI/DI 40195327518494 (each), 10195327518493 (case), Lot Numbers: 24ABC540; 34) REF DYNJ65271C, UDI/DI 40193489957946 (each), 10193489957945 (case), Lot Numbers: 23KBC696; 35) REF DYNJ66832, UDI/DI 40193489389051 (each), 10193489389050 (case), Lot Numbers: 23KBE083; 36) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23LBP941; 37) REF DYNJ69165D, UDI/DI 40195327224340 (each), 10195327224349 (case), Lot Numbers: 23KBE571; 38) REF DYNJ80082, UDI/DI 40195327012008 (each), 10195327012007 (case), Lot Numbers: 24ABD342; 39) REF DYNJ80232, UDI/DI 40195327017065 (each), 10195327017064 (case), Lot Numbers: 23LBN193; 40) REF DYNJ80483, UDI/DI 40195327045341 (each), 10195327045340 (case), Lot Numbers: 24ABC583; 41) REF DYNJ81640, UDI/DI 40195327129478 (each), 10195327129477 (case), Lot Numbers: 23LBK169; 42) REF DYNJ81796A, UDI/DI 40195327570386 (each), 10195327570385 (case), Lot Numbers: 23LBN670; 43) REF DYNJ83799C, UDI/DI 40195327443932 (each), 10195327443931 (case), Lot Numbers: 23LBP953; 44) REF DYNJ85275, UDI/DI 40195327484690 (each), 10195327484699 (case), Lot Numbers: 24ABA128; 45) REF DYNJ908059A, UDI/DI 40195327125432 (each), 10195327125431 (case), Lot Numbers: 23LBT833; 46) REF LLSCAEYE01A, UDI/DI 40884389376981 (each), 10884389376980 (case), Lot Numbers: 23KBB457; 47) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABD326; 48) REF LYN011PHNHD, UDI/DI 40193489234405 (each), 10193489234404 (case), Lot Numbers: 24ABA918; 49) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 24ABA470; 50) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23LBN465; 51) REF LYN023BPSSD, UDI/DI 40193489640954 (each), 10193489640953 (case), Lot Numbers: 23KBF760; 52) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABC586; 53) REF LYN023BSBLB, UDI/DI 40889942336242 (each), 10889942336241 (case), Lot Numbers: 24ABD327; 54) REF LYN023OPSOB, UDI/DI 40889942375791 (each), 10889942375790 (case), Lot Numbers: 24ABD328; 55) REF LYN024CACSB, UDI/DI 40195327095735 (each), 10195327095734 (case), Lot Numbers: 23LBN673; 56) REF LYN030BCSDB, UDI/DI 40193489457965 (each), 10193489457964 (case), Lot Numbers: 24ABH583; 57) REF LYN030CPSSA, UDI/DI 40195327128549 (each), 10195327128548 (case), Lot Numbers: 23KBD385; 58) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 24ABA502; 59) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBP443; 60) REF LYN030CTAKG, UDI/DI 40193489465946 (each), 10193489465945 (case), Lot Numbers: 23LBQ089; 61) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABA893; 62) REF LYN030VAEYA, UDI/DI 40195327242917 (each), 10195327242916 (case), Lot Numbers: 24ABD329; 63) REF LYN035CTSEC, UDI/DI 40889942532026 (each), 10889942532025 (case), Lot Numbers: 23KBC621; 64) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23LBQ090; 65) REF LYN037DBEYM, UDI/DI 40193489473910 (each), 10193489473919 (case), Lot Numbers: 23KBD746; 66) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 24ABD867; 67) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBN722; 68) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23LBA842; 69) REF LYN041OPFCC, UDI/DI 40889942357841 (each), 10889942357840 (case), Lot Numbers: 23KBD251; 70) REF LYN042CPFEG, UDI/DI 40193489219372 (each), 10193489219371 (case), Lot Numbers: 23KBC622; 71) REF PHS529724000B, UDI/DI 40195327166022 (each), 10195327166021 (case), Lot Numbers: 23KBE642; 72) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 24ABE054; 73) REF VAL001CPMEB, UDI/DI 40195327205455 (each), 10195327205454 (case), Lot Numbers: 23LBH892; 74) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 24ABN974; 75) REF VAL002CATSG, UDI/DI 40195327250417 (each), 10195327250416 (case), Lot Numbers: 23KBC653; 76) REF VAL003REPEA, UDI/DI 40889942968382 (each), 10889942968381 (case), Lot Numbers: 24ABF774; 77) REF VAL009CAAHC, UDI/DI 40195327260300 (each), 10195327260309 (case), Lot Numbers: 23KBB402; 78) REF VAL009CAREA, UDI/DI 40193489462242 (each), 10193489462241 (case), Lot Numbers: 23KBC624; 79) REF VAL009CATEA, UDI/DI 40889942872399 (each), 10889942872398 (case), Lot Numbers: 24ABA924; 80) REF VAL009CTSGA, UDI/DI 40193489577540 (each), 10193489577549 (case), Lot Numbers: 24ABA478; 81) REF VAL009EYDLC, UDI/DI 40195327302291 (each), 10195327302290 (case), Lot Numbers: 24ABE052; 82) REF VAL009RETGA, UDI/DI 40193489676991 (each), 10193489676990 (case), Lot Numbers: 23LBQ654; 83) REF VAL009VIREA, UDI/DI 40193489462259 (each), 10193489462258 (case), Lot Numbers: 24ABA925; 84) REF VAL011CTVAA, UDI/DI 40889942005568 (each), 10889942005567 (case), Lot Numbers: 23KBC625; 85) REF VAL022BSOMD, UDI/DI 40889942760214 (each), 10889942760213 (case), Lot Numbers: 23LBQ097; 86) REF VAL024CAIOD, UDI/DI 40193489491525 (each), 10193489491524 (case), Lot Numbers: 23KBB700; 87) REF VAL024EYTRB, UDI/DI 40193489426008 (each), 10193489426007 (case), Lot Numbers: 23LBN467; 88) REF VAL026CTNFC, UDI/DI 40193489458412 (each), 10193489458411 (case), Lot Numbers: 23LBA843; 89) REF VAL029EYGSB, UDI/DI 40193489550727 (each), 10193489550726 (case), Lot Numbers: 23KBT152; 90) REF VAL031IOGCB, UDI/DI 40889942307198 (each), 10889942307197 (case), Lot Numbers: 24ABA898; 91) REF VAL035CPAEC, UDI/DI 40889942537373 (each), 10889942537372 (case), Lot Numbers: 23KBE643; 92) REF VAL036CABRD, UDI/DI 40195327196159 (each), 10195327196158 (case), Lot Numbers: 23KBC657; 93) REF VAL037ICBVG, UDI/DI 40193489868136 (each), 10193489868135 (case), Lot Numbers: 23KBC628; 94) REF VAL038BSCID, UDI/DI 40888277761767 (each), 10888277761766 (case), Lot Numbers: 23KBC629; 95) REF VAL038CTECB, UDI/DI 40889942867883 (each), 10889942867882 (case), Lot Numbers: 23LBP453; 96) REF VAL041EPSWA, UDI/DI 40193489394550 (each), 10193489394559 (case), Lot Numbers: 24ABA469; 97) REF VAL042EYBHC, UDI/DI 40195327033249 (each), 10195327033248 (case), Lot Numbers: 23KBD595; 98) REF VAL046CAWCA, UDI/DI 40193489846721 (each), 10193489846720 (case), Lot Numbers: 23LBM013; 99) REF VAL047VIVOA, UDI/DI 40193489375122 (each), 10193489375121 (case), Lot Numbers: 23LBM392; 100) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23LBQ099; 101) REF VAL048TSCCA, UDI/DI 40195327250455 (each), 10195327250454 (case), Lot Numbers: 23KBC660; 102) REF VAL050CTFEI, UDI/DI 40193489368063 (each), 10193489368062 (case), Lot Numbers: 24ABA899; 103) REF VAL050EEPKB, UDI/DI 40195327267149 (each), 10195327267148 (case), Lot Numbers: 24ABA472; 104) REF VAL050ITKEA, UDI/DI 40195327134090 (each), 10195327134099 (case), Lot Numbers: 23KBK068; 105) REF VAL050REBOB, UDI/DI 40193489833653 (each), 10193489833652 (case), Lot Numbers: 24ABA477; 106) REF VAL050VIAHD, UDI/DI 40195327195565 (each), 10195327195564 (case), Lot Numbers: 23JBU308; 107) REF VAL054CAMAA, UDI/DI 40193489228114 (each), 10193489228113 (case), Lot Numbers: 23LBQ100; 108) REF VAL059DKSWB, UDI/DI 40193489667951 (each), 10193489667950 (case), Lot Numbers: 23KBE384; 109) REF VAL075EYLSA, UDI/DI 40889942804345 (each), 10889942804344 (case), Lot Numbers: 23LBP466; 110) REF VAL089EYRUA, UDI/DI 40193489438162 (each), 10193489438161 (case), Lot Numbers: 23LBP468
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
32 other products · FDA event 95415This product is part of a recall event; the main page for the event is Medline medical procedure convenience kits, labeled as recalled.
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