--- title: "Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, R... — FDA record Z-0161-2025 | Is It on Recall" description: "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" url: https://isitonrecall.com/recall/fda-device-z-0161-2025-medline-brand-medical-procedure-convenience-kits-labeled-as-1-cysto-cds-ref-cds983525d-2-cysto-cds-r/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS9835... — FDA record Z-0161-2025 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 Sep 4, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, REF DYNJ25834B; 4) CYSTO PACK, REF DYNJ35569C; 5) PAVILION MINOR PACK, REF DYNJ40724D; 6) CYSTOSCOPY PACK, REF DYNJ41105C; 7) MINOR PACK, REF DYNJ42132A; 8) RECTAL PRONE PACK, REF DYNJ43380A; 9) HERNIA APPENDECTOMY TEGH-LF, REF DYNJ46716; 10) CYSTO PACK, REF DYNJ47821F; 11) CYSTO PACK, REF DYNJ48978C; 12) CYSTO PACK, REF DYNJ50428C; 13) MID HUDSON CYSTO PACK, REF DYNJ53418B; 14) CYSTO PACK-LF, REF DYNJ55479D; 15) CYSTO PACK, REF DYNJ58445A; 16) MINOR PACK, REF DYNJ58566B; 17) CSTM PK GEN NEW ENGL SURG, REF DYNJ59431; 18) RIDGEWOOD LAP PACK-LF, REF DYNJ60077A; 19) FLEXIBLE CYS PACK, REF DYNJ62111C; 20) CYSTO PACK, REF DYNJ65830A; 21) MAIN & ODS CYSTO PACK, REF DYNJ66821A; 22) PROCEDURE CYSTO PACK, REF DYNJ68883; 23) CYSTO PACK, REF DYNJ69729; 24) MINOR SURGERY PACK, REF DYNJ80004; 25) LAPAROSCOPY PACK, REF DYNJ80763; 26) LAPAROSCOPY PACK, REF DYNJ80763; 27) CYSTO PACK, REF DYNJ82626; 28) MINOR PACK, REF DYNJ83155; 29) SY CYSTO, REF DYNJ900583M; 30) CYSTO, REF DYNJ905569B; 31) CYSTO, REF DYNJ907541A; 32) SET UP PACK-LF, REF LLSCASET01; 33) MAJOR PACK, REF SYNJ910011B - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: MEDLINE INDUSTRIES, LP - Northfield - **Quantity**: 5972 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0161-2025 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0161-2025%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). 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) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 24ABW238; 2) REF CDS983525D, UDI/DI 40195327429905 (each) 10195327429904 (case), Lot Numbers: 23KBU714; 3) REF DYNJ25834B, UDI/DI 40193489849555 (each) 10193489849554 (case), Lot Numbers: 24ABG332; 4) REF DYNJ35569C, UDI/DI 40195327498253 (each) 10195327498252 (case), Lot Numbers: 23LBL736; 5) REF DYNJ40724D, UDI/DI 40195327420773 (each) 10195327420772 (case), Lot Numbers: 24ABG713; 6) REF DYNJ41105C, UDI/DI 40193489969659 (each) 10193489969658 (case), Lot Numbers: 24ABA628; 7) REF DYNJ42132A, UDI/DI 40195327385270 (each) 10195327385279 (case), Lot Numbers: 23LBS108; 8) REF DYNJ43380A, UDI/DI 40888277265913 (each) 10888277265912 (case), Lot Numbers: 23KBD028; 9) REF DYNJ46716, UDI/DI 40888277597069 (each) 10888277597068 (case), Lot Numbers: 23LBM976; 10) REF DYNJ47821F, UDI/DI 40193489956796 (each) 10193489956795 (case), Lot Numbers: 24ABC507; 11) REF DYNJ48978C, UDI/DI 40195327325948 (each) 10195327325947 (case), Lot Numbers: 23LBP883; 12) REF DYNJ50428C, UDI/DI 40195327504039 (each) 10195327504038 (case), Lot Numbers: 23LBN301; 13) REF DYNJ53418B, UDI/DI 40195327372270 (each) 10195327372279 (case), Lot Numbers: 23LBO773; 14) REF DYNJ55479D, UDI/DI 40195327416769 (each) 10195327416768 (case), Lot Numbers: 23LBL444; 15) REF DYNJ58445A, UDI/DI 40195327585953 (each) 10195327585952 (case), Lot Numbers: 23LBU911; 16) REF DYNJ58566B, UDI/DI 40195327243228 (each) 10195327243227 (case), Lot Numbers: 23KBC919; 17) REF DYNJ59431, UDI/DI 40888277741257 (each) 10888277741256 (case), Lot Numbers: 24ABG210; 18) REF DYNJ60077A, UDI/DI 40193489862905 (each) 10193489862904 (case), Lot Numbers: 23LBO542; 19) REF DYNJ62111C, UDI/DI 40195327312146 (each) 10195327312145 (case), Lot Numbers: 23LBP204; 20) REF DYNJ65830A, UDI/DI 40195327588732 (each) 10195327588731 (case), Lot Numbers: 23LBR366; 21) REF DYNJ66821A, UDI/DI 40193489974929 (each) 10193489974928 (case), Lot Numbers: 23KBQ852; 22) REF DYNJ68883, UDI/DI 40193489848329 (each) 10193489848328 (case), Lot Numbers: 23KBC527; 23) REF DYNJ69729, UDI/DI 40193489973267 (each) 10193489973266 (case), Lot Numbers: 24ABD664; 24) REF DYNJ80004, UDI/DI 40195327005192 (each) 10195327005191 (case), Lot Numbers: 23LBP094; 25) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 24ABG464; 26) REF DYNJ80763, UDI/DI 40195327076611 (each) 10195327076610 (case), Lot Numbers: 23LBU050; 27) REF DYNJ82626, UDI/DI 40195327199488 (each) 10195327199487 (case), Lot Numbers: 24ABN216; 28) REF DYNJ83155, UDI/DI 40195327236855 (each) 10195327236854 (case), Lot Numbers: 23LBV474; 29) REF DYNJ900583M, UDI/DI 40195327061853 (each) 10195327061852 (case), Lot Numbers: 24ABU214; 30) REF DYNJ905569B, UDI/DI 40193489995672 (each) 10193489995671 (case), Lot Numbers: 24ABJ966; 31) REF DYNJ907541A, UDI/DI 40195327054268 (each) 10195327054267 (case), Lot Numbers: 23KBT202; 32) REF LLSCASET01, UDI/DI 40080196120681 (each) 10080196120680 (case), Lot Numbers: 23LBM079; 33) REF SYNJ910011B, UDI/DI 40195327246809 (each) 10195327246808 (case), Lot Numbers: 24ABS212 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution Worldwide distribution - US Nationwide and the countries of Canada, Panama. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Alaska](https://isitonrecall.com/state/alaska/) - [Alabama](https://isitonrecall.com/state/alabama/) - [Arkansas](https://isitonrecall.com/state/arkansas/) - [Arizona](https://isitonrecall.com/state/arizona/) - [California](https://isitonrecall.com/state/california/) - [Colorado](https://isitonrecall.com/state/colorado/) - [Connecticut](https://isitonrecall.com/state/connecticut/) - [Delaware](https://isitonrecall.com/state/delaware/) - [Florida](https://isitonrecall.com/state/florida/) - [Georgia](https://isitonrecall.com/state/georgia/) - [Hawaii](https://isitonrecall.com/state/hawaii/) - [Iowa](https://isitonrecall.com/state/iowa/) - [Idaho](https://isitonrecall.com/state/idaho/) - [Illinois](https://isitonrecall.com/state/illinois/) - [Indiana](https://isitonrecall.com/state/indiana/) - [Kansas](https://isitonrecall.com/state/kansas/) - [Kentucky](https://isitonrecall.com/state/kentucky/) - [Louisiana](https://isitonrecall.com/state/louisiana/) - [Massachusetts](https://isitonrecall.com/state/massachusetts/) - [Maryland](https://isitonrecall.com/state/maryland/) - [Maine](https://isitonrecall.com/state/maine/) - [Michigan](https://isitonrecall.com/state/michigan/) - [Minnesota](https://isitonrecall.com/state/minnesota/) - [Missouri](https://isitonrecall.com/state/missouri/) - [Mississippi](https://isitonrecall.com/state/mississippi/) - [Montana](https://isitonrecall.com/state/montana/) - [North Carolina](https://isitonrecall.com/state/north-carolina/) - [North Dakota](https://isitonrecall.com/state/north-dakota/) - [Nebraska](https://isitonrecall.com/state/nebraska/) - [New Hampshire](https://isitonrecall.com/state/new-hampshire/) - [New Jersey](https://isitonrecall.com/state/new-jersey/) - [New Mexico](https://isitonrecall.com/state/new-mexico/) - [Nevada](https://isitonrecall.com/state/nevada/) - [New York](https://isitonrecall.com/state/new-york/) - [Ohio](https://isitonrecall.com/state/ohio/) - [Oklahoma](https://isitonrecall.com/state/oklahoma/) - [Oregon](https://isitonrecall.com/state/oregon/) - [Pennsylvania](https://isitonrecall.com/state/pennsylvania/) - [Rhode Island](https://isitonrecall.com/state/rhode-island/) - [South Carolina](https://isitonrecall.com/state/south-carolina/) - [South Dakota](https://isitonrecall.com/state/south-dakota/) - [Tennessee](https://isitonrecall.com/state/tennessee/) - [Texas](https://isitonrecall.com/state/texas/) - [Utah](https://isitonrecall.com/state/utah/) - [Virginia](https://isitonrecall.com/state/virginia/) - [Vermont](https://isitonrecall.com/state/vermont/) - [Washington](https://isitonrecall.com/state/washington/) - [Wisconsin](https://isitonrecall.com/state/wisconsin/) - [West Virginia](https://isitonrecall.com/state/west-virginia/) - [Wyoming](https://isitonrecall.com/state/wyoming/) ## Dates in the source - **Report date**: Oct 30, 2024 - **Recall initiation date**: Sep 4, 2024 - **Center classification date**: Oct 23, 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. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0161-2025%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [MEDLINE INDUSTRIES, LP - Northfield records](https://isitonrecall.com/brand/medline-industries-lp-northfield/)