--- title: "See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model N... — FDA record Z-2109-2026 | Is It on Recall" description: "Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated ster" url: https://isitonrecall.com/recall/fda-device-z-2109-2026-see-full-list-in-res-exceeds-character-limit-1-gyn-laparoscopy-cds-model-number-cds981504g-2-bap-nor/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC ... — FDA record Z-2109-2026 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: See full list in RES, exceeds character limit 1) GYN LAPAROSCOPY CDS, Model Number: CDS981504G; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407P; 3) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 4) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 5) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 6) ROBOTIC-LF, Model Number: CDS984543D; 7) ROBOTIC-LF, Model Number: CDS984543F; 8) ROBOTIC-LF, Model Number: CDS984543G; 9) ROBOTIC-LF, Model Number: CDS984543I; 10) GYN CDS, Model Number: CDS984860F; 11) GYN LAP PELVI, Model Number: CDS985423G; 12) GYN KIT, Model Number: DYKM1657A; 13) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 14) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 15) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 16) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 17) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 18) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 19) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 20) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 21) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 22) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; - **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**: 15806 units - **Agency-reported status**: Ongoing - **Source record identifier**: Z-2109-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2109-2026%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) CDS981504G, UDI-DI: 10195327157968(each), 40195327157969(case), Lot Number: 25BDB744; 2) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23EBE997; 3) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23GBL921; 4) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23GBO574; 5) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23IBC607; 6) CDS982407P, UDI-DI: 10195327110116(each), 40195327110117(case), Lot Number: 23JBQ095; 7) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 8) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 18) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 19) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 20) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 21) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 22) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 23) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 24) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 25) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 26) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 27) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 28) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 29) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 30) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24AMJ461; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 36) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 37) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 38) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 39) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 40) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 41) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 42) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 43) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 44) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 45) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 46) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 47) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 48) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 49) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 50) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 51) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 52) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 53) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 54) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 55) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 56) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 57) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 58) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 59) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 60) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 61) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 62) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24DBS388; 63) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24FBC411; 64) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24GBK948; 65) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24IBV184; 66) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 67) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABJ213; 68) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABL615; 69) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBA024; 70) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBP181; 71) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21EBG218; 72) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21FBP762; 73) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21HBK337; 74) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBC127; 75) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBX803; 76) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBP646; 77) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBY301; 78) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22BBR618; 79) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22CBX517; 80) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22FBI695; 81) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22HBL832; 82) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 22JBC546; 83) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23KBA328; 84) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23LBE369; 85) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24ABX678; 86) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24CBJ465; 87) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24DBV608; 88) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24JBD270; 89) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBF533; 90) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBI207; 91) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25FBR662; 92) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25GBX843; 93) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25HBB957; 94) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21ABI984; 95) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21BBG518; 96) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21EBK837; 97) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBP369; 98) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBU222; 99) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21IBL095; 100) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21JBJ225; 101) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21KBQ606; 102) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL283; 103) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL299; 104) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22CBX518; 105) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22HBP253; 106) DYKMBNDL168A, UDI-DI: 10195327240806(each), 40195327240807(case), Lot Number: 23FBJ346; 107) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBJ568; 108) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBV008; 109) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24HBK278; 110) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25ABS671; 111) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25BBF014; 112) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25FBJ143; 113) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25HBC798; 114) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBG179; 115) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBQ333; 116) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21ABJ086; 117) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21BBG520; 118) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21FBP714; 119) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21HBK341; 120) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21IBO770; 121) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21LBJ751; 122) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22GBZ017; 123) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22HBB985; 124) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ABJ861; 125) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21BLA496; 126) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21DLA017; 127) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA256; 128) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA352; 129) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA658; 130) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21HLA598; 131) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21JLA896; 132) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA163; 133)... | The agency lot list is longer than this excerpt. [Read the complete list at the official source](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2109-2026%22). 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](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**: 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. ## 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-2109-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [Medline Industries, LP records](https://isitonrecall.com/brand/medline-industries-lp/)