Recall
FDAHealthJanuary 7, 2026

Medline Industries, LP — Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401

⚠️ Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
January 7, 2026

Worldwide distribution - US Nationwide.

What's affected?

Product
Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CSModel Number: DYNJP8401
Lot code
72525030011

Additional details

1) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525030011; 2) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525050004; 3) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100025; 4) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525100068; 5) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525020012; 6) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525040038; 7) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060015; 8) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525060041; 9) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080004; 10) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525080039; 11) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120082; 12) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120084; 13) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72519120097; 14) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520020055; 15) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030039; 16) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030064; 17) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520030074; 18) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520050047; 19) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060018; 20) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520060019; 21) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520070016; 22) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080003; 23) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080004; 24) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520080059; 25) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520100068; 26) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120003; 27) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72520120004; 28) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521040001; 29) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050060; 30) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050064; 31) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521050167; 32) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521060070; 33) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070019; 34) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521070099; 35) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521080017; 36) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090001; 37) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521090015; 38) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100005; 39) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521100033; 40) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110009; 41) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521110016; 42) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120009; 43) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72521120031; 44) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522010013; 45) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522020010; 46) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522030020; 47) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522040019; 48) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050012; 49) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522050015; 50) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060019; 51) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522060052; 52) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522070003; 53) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522080008; 54) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110004; 55) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522110040; 56) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72522120006; 57) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100020; 58) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523100063; 59) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523110004; 60) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72523120076; 61) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010036; 62) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524010087; 63) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524030056; 64) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524040002; 65) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524050034; 66) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060001; 67) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060034; 68) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524060098; 69) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524070001; 70) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524080004; 71) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090003; 72) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524090078; 73) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100004; 74) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524100099; 75) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524110013; 76) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72524120003; 77) DYNJP1050UG, UDI-DI: 10080196573509(each), 40080196573500(case), Lot Number: 72525010001; 78) DYNJP8401, UDI-DI: 10080196740710(each), 40080196740711(case), Lot Number: 72521080034

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 193157 units.

View original FDA notice →

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