Recall archive / FDA device enforcement
Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS98... — FDA record Z-1415-2026
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
- Medline Convenience Kits: 1) ROBOTIC GYN CDS-1, Model Number: CDS982893I; 2) GYN LAPAROSCOPY CDS, Model Number: CDS983300J; 3) NHP ROBOTIC GYNE CDS, Model Number: CDS984243G; 4) ROBOTIC-LF, Model Number: CDS984543D; 5) ROBOTIC-LF, Model Number: CDS984543F; 6) ROBOTIC-LF, Model Number: CDS984543G; 7) ROBOTIC-LF, Model Number: CDS984543I; 8) GYN CDS, Model Number: CDS984860F; 9) GYN LAP PELVI, Model Number: CDS985423G; 10) GYN KIT, Model Number: DYKM1657A; 11) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL100; 12) KIT ROBOTICS GYN, Model Number: DYKMBNDL109; 13) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116D; 14) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116F; 15) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119; 16) KIT GYN VAGINAL MAJOR, Model Number: DYKMBNDL119A; 17) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168; 18) KIT GYN ABDOMINAL MAJOR, Model Number: DYKMBNDL168A; 19) KIT THORACIC ROBOTIC LOBECTOMY, Model Number: DYKMBNDL184D; 20) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91; 21) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92; 22) KIT GYN ONCOLOGY, Model Number: DYKMBNDL92A; 23) KIT GYN ABDOMINAL, Model Number: DYKMBNDL92C; 24) KIT GYN LAP, Model Number: DYKMBNDL94; 25) KIT GYN LAP, Model Number: DYKMBNDL94A; 26) KIT GYN LAP, Model Number: DYKMBNDL94C; 27) KIT GYN LAP, Model Number: DYKMBNDL94D; 28) GYN LAPAROSCOPY PACK-LF, Model Number: DYNJ0281948N; 29) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372F; 30) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372G; 31) PROSTATE ROBOTIC PACK, Model Number: DYNJ0347372I; 32) HEALTH ALL GYN LAP PACK-LF, Model Number: DYNJ28252G; 33) GYN OPERATIVE LAP PACK-LF, Model Number: DYNJ30005G; 34) OB PACK, Model Number: DYNJ32706B; 35) ROBOTIC UROLOGY-RF, Model Number: DYNJ38844N; 36) ENSEMBLE GYNE LAPAROTOMIE-LF, Model Number: DYNJ47550C; 37) GYN LAP PACK, Model Number: DYNJ47714A; 38) TASC GYN LAP, Model Number: DYNJ49191B; 39) ROBOTIC PACK, Model Number: DYNJ49705K; 40) GYN LAPAROSCOPY PACK, Model Number: DYNJ50348F; 41) NWH GYN LAPAROSCOPY, Model Number: DYNJ50439F; 42) FH LAPAROSCOPIC GYN PK-LF, Model Number: DYNJ51795F; 43) GYN LAPAROSCOPY PACK, Model Number: DYNJ52569B; 44) LAVH PACK, Model Number: DYNJ55862; 45) PK, GEN-LAPAROSCOPY, Model Number: DYNJ57607A; 46) GYN LAPAROSCOPY MRNGSD, Model Number: DYNJ58321A; 47) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079B; 48) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079C; 49) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079D; 50) GYN LAPAROSCOPY PACK, Model Number: DYNJ63079F; 51) GYN DAVINCI PACK, Model Number: DYNJ64266; 52) DAVINCI PACK, Model Number: DYNJ66298D; 53) GYN LAPAROSCOPY, Model Number: DYNJ67269; 54) GENERAL GYN PACK, Model Number: DYNJ68710; 55) LAP GYN PACK, Model Number: DYNJ69419A; 56) LAP GYN PACK, Model Number: DYNJ69419D; 57) GYN LAPAROSCOPY, Model Number: DYNJ81492A; 58) PK, ROBOTIC GYN & GU-ROSE MEDI, Model Number: DYNJ81761A; 59) GYN PACK, Model Number: DYNJ83475A; 60) ROBOTIC XI PACK, Model Number: DYNJ84783; ...
- 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
- 12418 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1415-2026
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) CDS982893I, UDI-DI: 10889942208050(each), 40889942208051(case), Lot Number: 24IBO240; 2) CDS983300J, UDI-DI: 10193489425048(each), 40193489425049(case), Lot Number: 21CDB781; 3) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBX440; 4) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23CBN644; 5) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 23ABC549; 6) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22OBM422; 7) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22KBD152; 8) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22JBC547; 9) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22HBV491; 10) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22GBP114; 11) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22FBV462; 12) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 22BBL450; 13) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21VBA272; 14) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21IBM804; 15) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21HBN807; 16) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21GBI171; 17) CDS984243G, UDI-DI: 10193489872521(each), 40193489872522(case), Lot Number: 21EBA117; 18) CDS984543D, UDI-DI: 10195327072322(each), 40195327072323(case), Lot Number: 22CBC587; 19) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22OBL925; 20) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22KMD619; 21) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22JMA223; 22) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMG671; 23) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22HMB259; 24) CDS984543F, UDI-DI: 10195327115647(each), 40195327115648(case), Lot Number: 22GBD616; 25) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 24BMH483; 26) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23LMA864; 27) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23JMC376; 28) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23IMA629; 29) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMH282; 30) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23GMF425; 31) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23FMI171; 32) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23EMI460; 33) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23DMA508; 34) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23CMC582; 35) CDS984543G, UDI-DI: 10195327299637(each), 40195327299638(case), Lot Number: 23BMD680; 36) CDS984543I, UDI-DI: 10195327637071(each), 40195327637072(case), Lot Number: 24CMH050; 37) CDS984860F, UDI-DI: 10193489261974(each), 40193489261975(case), Lot Number: 21ADB205; 38) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21DBV243; 39) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH547; 40) CDS985423G, UDI-DI: 10193489319323(each), 40193489319324(case), Lot Number: 21CBH282; 41) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25LBN225; 42) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25HBS386; 43) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25FBS108; 44) DYKM1657A, UDI-DI: 10198459297410(each), 40198459297411(case), Lot Number: 25DBN805; 45) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21JBD206; 46) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21GBP406; 47) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21EBA097; 48) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21BBG514; 49) DYKMBNDL100, UDI-DI: 10193489477955(each), 40193489477956(case), Lot Number: 21ABI962; 50) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABW347; 51) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABO060; 52) DYKMBNDL109, UDI-DI: 10193489478211(each), 40193489478212(case), Lot Number: 21ABM086; 53) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24DBA349; 54) DYKMBNDL116D, UDI-DI: 10195327608866(each), 40195327608867(case), Lot Number: 24CBF889; 55) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24JBB328; 56) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24IBV184; 57) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24GBK948; 58) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24FBC411; 59) DYKMBNDL116F, UDI-DI: 10198459000706(each), 40198459000707(case), Lot Number: 24DBS388; 60) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22HBL832; 61) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22FBI695; 62) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22CBX517; 63) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 22BBR618; 64) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBY301; 65) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21LBP646; 66) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBX803; 67) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21JBC127; 68) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21HBK337; 69) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21FBP762; 70) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21EBG218; 71) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBP181; 72) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21BBA024; 73) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABL615; 74) DYKMBNDL119, UDI-DI: 10193489479317(each), 40193489479318(case), Lot Number: 21ABJ213; 75) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25HBB957; 76) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25GBX843; 77) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 25FBR662; 78) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBI207; 79) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24KBF533; 80) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24JBD270; 81) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24DBV608; 82) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24CBJ465; 83) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 24ABX678; 84) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23LBE369; 85) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 23KBA328; 86) DYKMBNDL119A, UDI-DI: 10195327241025(each), 40195327241026(case), Lot Number: 22JBC546; 87) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22HBP253; 88) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22CBX518; 89) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL299; 90) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 22ABL283; 91) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21KBQ606; 92) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21JBJ225; 93) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21IBL095; 94) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBU222; 95) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21GBP369; 96) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21EBK837; 97) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21BBG518; 98) DYKMBNDL168, UDI-DI: 10193489477436(each), 40193489477437(case), Lot Number: 21ABI984; 99) DYKMBNDL168A, UDI-DI: 10195327240806(each), 40195327240807(case), Lot Number: 23FBJ346; 100) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBQ333; 101) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25LBG179; 102) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25HBC798; 103) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25FBJ143; 104) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25BBF014; 105) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 25ABS671; 106) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24HBK278; 107) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBV008; 108) DYKMBNDL184D, UDI-DI: 10198459000485(each), 40198459000486(case), Lot Number: 24GBJ568; 109) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22HBB985; 110) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 22GBZ017; 111) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21LBJ751; 112) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21IBO770; 113) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21HBK341; 114) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21FBP714; 115) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21BBG520; 116) DYKMBNDL91, UDI-DI: 10193489477870(each), 40193489477871(case), Lot Number: 21ABJ086; 117) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22HLA664; 118) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELB163; 119) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ELA227; 120) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22DLB036; 121) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22CLA119; 122) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22BLA918; 123) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA331; 124) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 22ALA125; 125) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA284; 126) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21LLA163; 127) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21JLA896; 128) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21HLA598; 129) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA658; 130) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA352; 131) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21ELA256; 132) DYKMBNDL92, UDI-DI: 10193489477351(each), 40193489477352(case), Lot Number: 21DLA017; 133)... |
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 distribution - US Nationwide.
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
- Feb 25, 2026
- Recall initiation date
- Jan 7, 2026
- Center classification date
- Feb 17, 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.