CLASS II ONGOING Device recall · Reported 23 Apr 2025 · FDA Enforcement Report
Medline Convenience kits used for various procedures: T A PACK recalled
Medline Industries LP - Northfield is recalling Medline Convenience kits used for various procedures: T A PACK, distributed nationwide in the US. The recall was initiated on 3 Mar 2025 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-1597-2025
- FDA event ID
- 96510
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Mar 2025
- FDA classified
- 17 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Pacemakers & Defibrillators
Timeline
| 3 Mar 2025 | Recall initiated by company | |
| 17 Apr 2025 | Classified by FDA | +45 days |
| 23 Apr 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
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 Convenience kits used for various procedures: 1) T A PACK, Model Number: DYNJ67791A; 2) NASAL PACK, Model Number: DYNJ66514; 3) ENT PACK, Model Number: DYNJ67775A; 4) T/A ENDO PACK, Model Number: DYNJ83158; 5) T & A PACK, Model Number: DYNJ0634878I; 6) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 7) TONSIL PACK, Model Number: DYNJ44525C; 8) ENT TRAY, Model Number: DYNJ44391K; 9) ENT PACK, Model Number: DYNJ49300D; 10) NASAL PACK, Model Number: DYNJ61555B; 11) HEAD AND NECK, Model Number: DYNJ57287A; 12) SINUS ENDOSCOPY-LF, Model Number: DYNJ36720F; 13) ENT PACK, Model Number: DYNJ54035B; 14) ENT PACK, Model Number: DYNJ36516; 15) FESS PACK, Model Number: DYNJ59502B; 16) T AND A PACK, Model Number: DYNJ80790; 17) PK,ENT, Model Number: DYNJ57583; 18) ENT/LAP PACK, Model Number: DYNJ84876; 19) TONSIL PACK, Model Number: DYNJ50109B; 20) TONSIL, Model Number: DYNJ908452C; 21) CSS SINUS PACK, Model Number: DYNJ17005I; 22) ENT, Model Number: DYNJ910514; 23) ADULT ENT - OAKBEND, Model Number: DYNJ905762; 24) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 25) ENT PACK, Model Number: DYNJ31453D; 26) ENT PACK, Model Number: DYNJ59447A; 27) TONSIL PACK, Model Number: DYNJ26441R; 28) ORAL ENT PACK, Model Number: DYNJ58408A; 29) ENT PACK, Model Number: DYNJ51085; 30) DR LANO NASAL CHRISTUS, Model Number: DYNJ61196A; 31) ENT PACK, Model Number: DYNJ66178D; 32) BWNBORO EENT PACK-LF, Model Number: DYNJ37551A; 33) HEAD AND NECK PACK, Model Number: DYNJ68872F; 34) EENT PACK, Model Number: DYNJ50301C; 35) ENT PACK, Model Number: DYNJ40498B; 36) SHN-C-THYROIDECTOMY-LF, Model Number: DYNJ46869A; 37) MINOR CYSTO PACK, Model Number: DYNJ58727D; 38) TONSILS AND ADENOIDS, Model Number: DYNJ45171C; 39) T&A PACK, Model Number: DYNJ56543J; 40) ENT PACK, Model Number: DYNJ54035B; 41) TONSIL PACK, Model Number: DYNJ50109B; 42) ENT PACK, Model Number: DYNJ40139D; 43) NASAL/SEPTO PACK, Model Number: DYNJ32099A; 44) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 45) ENT PACK, Model Number: DYNJ53573A; 46) CHS ENT PACK II, Model Number: DYNJCH908; 47) SIMPLE NECK DISSECTION, Model Number: DYNJ47481F; 48) TONSIL PACK, Model Number: DYNJ81479A; 49) E.N.T. TRAY, Model Number: DYNJ22357K; 50) NASAL PACK, Model Number: DYNJ39317B; 51) HEAD AND NECK PACK, Model Number: DYNJ54321D; 52) T A PACK, Model Number: DYNJ67791A; 53) ENT PACK, Model Number: DYNJ42451B; 54) HEAD AND NECK PACK-FOX, Model Number: DYNJ53348C; 55) HEAD AND NECK PACK, Model Number: DYNJ58596B; 56) SINUS PACK, Model Number: DYNJ56262; 57) ENT PACK, Model Number: DYNJ51085; 58) TONSIL T AND A PACK SHD, Model Number: DYNJ68417C; 59) ENT PACK, Model Number: DYNJ48595; 60) T AND A PACK-LF, Model Number: DYNJ52611; 61) HEAD AND NECK PACK, Model Number: DYNJ81897B; 62) ENSEMBLE ORL THYROIDE-LF, Model Number: DYNJ43390A; 63) EENT PACK-LF, Model Number: DYNJ34728D; 64) ENT, Model Number: DYNJ910514; 65) TONSIL ADENOID CKHA-LF, Model Number: DYNJ41771C; 66) ENT PACK, Model Number: DYNJ68679B; 67) PACK,T & A ASC, Model Number: DYNJ906914; 68) EENT SPLIT PACK-LF, Model Number: LLSCAENT01; 69) ENT PACK, Model Number: DYNJ83603; 70) ENT PACK, Model Number: DYNJ32247; 71) PPM-ICD PACK-LF, Model Number: DYNJ15949D; 72) ENT PACK, Model Number: DYNJ31453D; 73) SINOSCOPY PACK-LF, Model Number: DYNJ25600L; 74) T & A PACK, Model Number: DYNJ38978C; 75) CSC-N T&A, Model Number: DYNJ50870D; 76) ENT I-LF, Model Number: DYNJS0702; 77) ENT KIT, Model Number: DYNJ902836F; 78) ENT PACK, Model Number: DYNJ66039B; 79) TONSIL CDS, Model Number: DYNJ907844D; 80) PACK,T & A ASC, Model Number: DYNJ906914
Where it was distributed
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
Questions about this recall
Why was it recalled?
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Which lots are affected?
1) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24IBE758; 2) DYNJ66514, UDI-DI: 10193489359282(each), 40193489359283(case), Lot Number: 24IBE817; 3) DYNJ67775A, UDI-DI: 10193489996258(each), 40193489996259(case), Lot Number: 24IBG346; 4) DYNJ83158, UDI-DI: 10195327236885(each), 40195327236886(case), Lot Number: 24IBG449; 5) DYNJ0634878I, UDI-DI: 10195327694500(each), 40195327694501(case), Lot Number: 24IBG548; 6) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24IBG570; 7) DYNJ44525C, UDI-DI: 10193489232042(each), 40193489232043(case), Lot Number: 24IBG608; 8) DYNJ44391K, UDI-DI: 10195327457648(each), 40195327457649(case), Lot Number: 24IBG848; 9) DYNJ49300D, UDI-DI: 10193489297287(each), 40193489297288(case), Lot Number: 24IBH734; 10) DYNJ61555B, UDI-DI: 10195327608101(each), 40195327608102(case), Lot Number: 24IBH769; 11) DYNJ57287A, UDI-DI: 10193489854152(each), 40193489854153(case), Lot Number: 24IBH959; 12) DYNJ36720F, UDI-DI: 10198459079306(each), 40198459079307(case), Lot Number: 24IBQ081; 13) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24IBQ933; 14) DYNJ36516, UDI-DI: 10884389544112(each), 40884389544113(case), Lot Number: 24IBR105; 15) DYNJ59502B, UDI-DI: 10193489372939(each), 40193489372930(case), Lot Number: 24IBR121; 16) DYNJ80790, UDI-DI: 10195327079482(each), 40195327079483(case), Lot Number: 24IBR337; 17) DYNJ57583, UDI-DI: 10889942755332(each), 40889942755333(case), Lot Number: 24IBR873; 18) DYNJ84876, UDI-DI: 10195327431778(each), 40195327431779(case), Lot Number: 24IBR895; 19) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24IBS352; 20) DYNJ908452C, UDI-DI: 10195327610937(each), 40195327610938(case), Lot Number: 24JBD799; 21) DYNJ17005I, UDI-DI: 10193489241860(each), 40193489241861(case), Lot Number: 24JBF130; 22) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24JBK654; 23) DYNJ905762, UDI-DI: 10193489507966(each), 40193489507967(case), Lot Number: 24JBK682; 24) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBK897; 25) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24JBM367; 26) DYNJ59447A, UDI-DI: 10193489707663(each), 40193489707664(case), Lot Number: 24JBM926; 27) DYNJ26441R, UDI-DI: 10198459085888(each), 40198459085889(case), Lot Number: 24JBN335; 28) DYNJ58408A, UDI-DI: 10889942969029(each), 40889942969020(case), Lot Number: 24JBN611; 29) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24JBN781; 30) DYNJ61196A, UDI-DI: 10195327604240(each), 40195327604241(case), Lot Number: 24JBN797; 31) DYNJ66178D, UDI-DI: 10198459100307(each), 40198459100308(case), Lot Number: 24JBN811; 32) DYNJ37551A, UDI-DI: 10888277585720(each), 40888277585721(case), Lot Number: 24JBT022; 33) DYNJ68872F, UDI-DI: 10198459079269(each), 40198459079260(case), Lot Number: 24JBT065; 34) DYNJ50301C, UDI-DI: 10198459052330(each), 40198459052331(case), Lot Number: 24JBT456; 35) DYNJ40498B, UDI-DI: 10193489806779(each), 40193489806770(case), Lot Number: 24JBV199; 36) DYNJ46869A, UDI-DI: 10198459069949(each), 40198459069940(case), Lot Number: 24JBV309; 37) DYNJ58727D, UDI-DI: 10198459048425(each), 40198459048426(case), Lot Number: 24JBV608; 38) DYNJ45171C, UDI-DI: 10889942485260(each), 40889942485261(case), Lot Number: 24JBV814; 39) DYNJ56543J, UDI-DI: 10195327453602(each), 40195327453603(case), Lot Number: 24JBW129; 40) DYNJ54035B, UDI-DI: 10195327680541(each), 40195327680542(case), Lot Number: 24JBW183; 41) DYNJ50109B, UDI-DI: 10198459115776(each), 40198459115777(case), Lot Number: 24JBW623; 42) DYNJ40139D, UDI-DI: 10195327663506(each), 40195327663507(case), Lot Number: 24JBX313; 43) DYNJ32099A, UDI-DI: 10195327610890(each), 40195327610891(case), Lot Number: 24JBY276; 44) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24JBY278; 45) DYNJ53573A, UDI-DI: 10193489201635(each), 40193489201636(case), Lot Number: 24JBY404; 46) DYNJCH908, UDI-DI: 10193489393347(each), 40193489393348(case), Lot Number: 24KBA907; 47) DYNJ47481F, UDI-DI: 10195327067335(each), 40195327067336(case), Lot Number: 24KBB421; 48) DYNJ81479A, UDI-DI: 10195327378370(each), 40195327378371(case), Lot Number: 24KBB455; 49) DYNJ22357K, UDI-DI: 10193489926736(each), 40193489926737(case), Lot Number: 24KBB793; 50) DYNJ39317B, UDI-DI: 10889942775729(each), 40889942775720(case), Lot Number: 24KBC590; 51) DYNJ54321D, UDI-DI: 10195327679323(each), 40195327679324(case), Lot Number: 24KBC663; 52) DYNJ67791A, UDI-DI: 10193489941715(each), 40193489941716(case), Lot Number: 24KBC754; 53) DYNJ42451B, UDI-DI: 10193489740318(each), 40193489740319(case), Lot Number: 24KBC910; 54) DYNJ53348C, UDI-DI: 10195327453565(each), 40195327453566(case), Lot Number: 24KBD155; 55) DYNJ58596B, UDI-DI: 10195327635947(each), 40195327635948(case), Lot Number: 24KBD243; 56) DYNJ56262, UDI-DI: 10889942624331(each), 40889942624332(case), Lot Number: 24KBD661; 57) DYNJ51085, UDI-DI: 10889942117284(each), 40889942117285(case), Lot Number: 24KBE334; 58) DYNJ68417C, UDI-DI: 10195327341633(each), 40195327341634(case), Lot Number: 24KBE396; 59) DYNJ48595, UDI-DI: 10888277915183(each), 40888277915184(case), Lot Number: 24KBE590; 60) DYNJ52611, UDI-DI: 10889942300853(each), 40889942300854(case), Lot Number: 24KBF355; 61) DYNJ81897B, UDI-DI: 10198459155710(each), 40198459155711(case), Lot Number: 24KBF577; 62) DYNJ43390A, UDI-DI: 10889942670321(each), 40889942670322(case), Lot Number: 24KBG019; 63) DYNJ34728D, UDI-DI: 10198459061851(each), 40198459061852(case), Lot Number: 24KBG035; 64) DYNJ910514, UDI-DI: 10198459021411(each), 40198459021412(case), Lot Number: 24KBG072; 65) DYNJ41771C, UDI-DI: 10889942599189(each), 40889942599180(case), Lot Number: 24KBG178; 66) DYNJ68679B, UDI-DI: 10195327129095(each), 40195327129096(case), Lot Number: 24KBG186; 67) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24KBG371; 68) LLSCAENT01, UDI-DI: 10080196120802(each), 40080196120803(case), Lot Number: 24KBG399; 69) DYNJ83603, UDI-DI: 10195327284886(each), 40195327284887(case), Lot Number: 24KBG953; 70) DYNJ32247, UDI-DI: 10884389203873(each), 40884389203874(case), Lot Number: 24KBG965; 71) DYNJ15949D, UDI-DI: 10195327573805(each), 40195327573806(case), Lot Number: 24KBG993; 72) DYNJ31453D, UDI-DI: 10195327286224(each), 40195327286225(case), Lot Number: 24KBG996; 73) DYNJ25600L, UDI-DI: 10889942686247(each), 40889942686248(case), Lot Number: 24KBH226; 74) DYNJ38978C, UDI-DI: 10195327583590(each), 40195327583591(case), Lot Number: 24KBH242; 75) DYNJ50870D, UDI-DI: 10195327165666(each), 40195327165667(case), Lot Number: 24KBH280; 76) DYNJS0702, UDI-DI: 10080196798728(each), 40080196798729(case), Lot Number: 24KBI176; 77) DYNJ902836F, UDI-DI: 10198459002816(each), 40198459002817(case), Lot Number: 24KBI638; 78) DYNJ66039B, UDI-DI: 10195327151997(each), 40195327151998(case), Lot Number: 24KBL783; 79) DYNJ907844D, UDI-DI: 10195327387334(each), 40195327387335(case), Lot Number: 24KBP945; 80) DYNJ906914, UDI-DI: 10193489280173(each), 40193489280174(case), Lot Number: 24LBA080
Where was it sold?
Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
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
33 other products · FDA event 96510This product is part of a recall event; the main page for the event is Medline Convenience kits used for various procedures: Nail Pack recalled.
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