Recall archive / FDA device enforcement
Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOP... — FDA record Z-2704-2024
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 Mar 22, 2024. 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
- Medline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO KIT, REF DYKE1462A; c) ENDOSCOPY KIT, REF DYKE1431B; d) ENDOSCOPY KIT, REF DYKE1623B; e) GENERAL LAPAROSCOPY, REF DYNJ902385I; f) GENERAL LAPAROSCOPY, REF DYNJ905508G; g) GENERAL LAPAROSCOPY V, REF DYNJS2032D; h) LAP APPY, REF DYNJ902383I; i) LAP CHOLE, REF DYNJ9062767D; j) LAP CHOLE, REF DYNJ907187A; k) MAJOR, REF DYNJ904768B; l) MAJOR, REF DYNJ905520F; m) MAJOR, REF DYNJ907154A; n) MAJOR SURGICAL, REF DYNJ905005C; o) MINOR, REF DYNJ907155A; p) MINOR SET UP, REF DYNJ909748; q) RHYZOTOMY, REF DYNJ902288I;
- Reason
- A slight dimensional variation which has the potential for increased difficulty fitting into outer canister.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 22891 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2704-2024
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 | a) REF DYNJ905000D, UDI/DI 40195327316908 (case), 10195327316907 (unit), Lot Numbers: 23BBG363, 23CBN659, 23GBH840, 23HBE163, 23IBJ724, 23KBW116; b) REF DYKE1462A, UDI/DI 40889942620167 (case), 10889942620166 (unit), Lot Numbers: 22FDC042, 22JDB988, 22LBJ315, 23BBL256, 23CBU426, 23EBH275, 23FBK205, 23IBF933; c) REF DYKE1431B, UDI/DI 40889942632313 (case), 10889942632312 (unit), Lot Numbers: 22EME324, 22FMG304, 22HMH828, 22JMC383, 22LMC594, 23AMH794, 23BMF552, 23CME449, 23DMA460, 23FMF461, 23HMD372, 23JMB833, 23LMC072; d) REF DYKE1623B, UDI/DI 40193489424943 (case), 10193489424942 (unit), Lot Numbers: 22EBN239, 22FBQ906, 22JBS556, 23ABD205, 23DBD052, 23FBD026, 23HBQ564, 23KBQ077; e) REF DYNJ902385I, UDI/DI 40193489978279 (case), 10193489978278 (unit), Lot Numbers: 22IBL707, 23ABF810, 23ABS802, 23CBE830, 23CBM190, 23EBC428, 23FBU051, 23HBV225, 23KBR543; f) REF DYNJ905508G, UDI/DI 40195327269075 (case), 10195327269074 (unit), Lot Numbers: 22LME748, 22LMF477, 22LMI027, 23AMB893, 23AMG865, 23EMA933, 23EMB427, 23GMB051, 23HMI600, 23IMG463, 23KMB250; g) REF DYNJS2032D, UDI/DI 40193489214155 (case), 10193489214154 (unit), Lot Numbers: 22JDA825, 22LDB688, 23HDC128, 23KDA676; h) REF DYNJ902383I, UDI/DI 40193488978590 (case), 10193489978599 (unit), Lot Numbers: 22FBF410, 22FBM118, 22GBV826, 22KBJ795, 22LBB636, 23ABM564, 23DBI048, 23EBJ423, 23FBC990, 23HBS791, 23JBR485, 23KBQ988; i) REF DYNJ9062767D, UDI/DI 40195327511037 (case), 10195327511036 (unit), Lot Numbers: 23JBH731; j) REF DYNJ907187A, UDI/DI 40193489970525 (case), 10193489970524 (unit), Lot Numbers: 22EMH533, 22FME336, 22LMB229, 23AME424, 23AMJ064; k) REF DYNJ904768B, UDI/DI 40195327137183 (case), 10195327137182 (unit), Lot Numbers: 22EMG657, 22FMH099, 22IMA134, 22IMD626, 22JMF012, 23BMC481, 23BMG491, 23EMF946, 23GMB885, 23JMJ232, 23LMD177; l) REF DYNJ905520F, UDI/DI 40195327421367 (case), 10195327421366 (unit), Lot Numbers: 23HME815, 23HMH202, 23IMA899, 23JMC171, 23KMH256; m) REF DYNJ907154A, UDI/DI 40193489970341 (case), 10193489970340 (unit), Lot Numbers: 22FMH851, 22IMA525, 22LMF668, 23BMG402, 23DMD186, 23DME333, 23EMF068, 23HMD762, 23HMH492, 23KMC012; n) REF DYNJ905005C, UDI/DI 40195327316946 (case), 10195327316945 (unit), Lot Numbers: 23ABL864, 23CBF410, 23DBF768, 23GBS885, 23IBD450; o) REF DYNJ907155A, UDI/DI 40193489970273 (case), 10193489970272 (unit), Lot Numbers: 22KME231, 22LME429, 23AMF052, 23EMF507, 23JMA490; p) REF DYNJ909748, UDI/DI 40195327468218 (case), 10195327468217 (unit), Lot Numbers: 23IMI101, 23KMB382; q) REF DYNJ902288I, UDI/DI 40195327442225 (case), 10195327442224 (unit), Lot Numbers: 23GBD871, 23IBT374, 23KBD099; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide - US Nationwide and the countries of Panama, Mexico, Canada, Qatar, El Salvador, Oman, Colombia, Singapore.
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
- Aug 28, 2024
- Recall initiation date
- Mar 22, 2024
- Center classification date
- Aug 22, 2024
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.