Recall archive / FDA device enforcement
See complete list in RES, exceeds character limit. Medline Surgical Gowns — FDA record Z-2129-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- See complete list in RES, exceeds character limit. Medline Surgical Gowns
- Reason
- 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.
- Classification
- Class II
- Recalling firm
- Medline Industries, LP
- Quantity
- 70376042 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2129-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525050165; 2) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070175; 3) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525070223; 4) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100047; 5) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100144; 6) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525100377; 7) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525020078; 8) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525040212; 9) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525060247; 10) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080205; 11) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525080306; 12) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525090277; 13) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30522040040; 14) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100129; 15) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30524100146; 16) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 30525010225; 17) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120001; 18) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72523120083; 19) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010047; 20) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524010092; 21) DYNJP2001, UDI-DI: 10080196073641(each), 40080196073642(case), Lot Number: 72524120004; 22) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050067; 23) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525050068; 24) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070040; 25) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070088; 26) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525070143; 27) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525070001; 28) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100019; 29) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100119; 30) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100124; 31) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525100187; 32) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100026; 33) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525100098; 34) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525020140; 35) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 72525020013; 36) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525040083; 37) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060001; 38) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060206; 39) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525060207; 40) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080067; 41) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080138; 42) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525080226; 43) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090032; 44) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090122; 45) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525090257; 46) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110045; 47) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30525110109; 48) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110009; 49) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110013; 50) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30519110023; 51) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010003; 52) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010007; 53) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010008; 54) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010012; 55) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520010015; 56) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520020032; 57) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520030005; 58) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520040007; 59) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520040089; 60) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520050017; 61) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520050018; 62) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060001; 63) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060002; 64) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060003; 65) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060056; 66) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060058; 67) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060061; 68) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520060063; 69) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070059; 70) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070079; 71) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070086; 72) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070092; 73) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070115; 74) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520070130; 75) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080058; 76) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080087; 77) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080090; 78) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520080092; 79) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520110018; 80) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30520110019; 81) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521010001; 82) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521100004; 83) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521100005; 84) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521110002; 85) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30521120059; 86) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010006; 87) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010007; 88) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010010; 89) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010034; 90) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522010035; 91) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030014; 92) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030121; 93) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030145; 94) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522030146; 95) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040040; 96) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040047; 97) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522040049; 98) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522050018; 99) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522060039; 100) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522070017; 101) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522070106; 102) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522100070; 103) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522110015; 104) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120036; 105) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120047; 106) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30522120183; 107) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010061; 108) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010066; 109) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010107; 110) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523010143; 111) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523020026; 112) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523020034; 113) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523030061; 114) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523050087; 115) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523050108; 116) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523060004; 117) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523060023; 118) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523080049; 119) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523090004; 120) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523100151; 121) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523110078; 122) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523110161; 123) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30523120112; 124) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524010007; 125) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524010008; 126) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524050302; 127) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524050303; 128) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524090183; 129) DYNJP2001S, UDI-DI: 10080196304660(each), 40080196304661(case), Lot Number: 30524100229; ... |
The agency lot list is longer than this excerpt. Read the complete list at the official source.
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- May 13, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- May 7, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.