PlainRecalls
FDA Devices Moderate Class II Ongoing

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY

Reported: December 11, 2024 Initiated: October 9, 2024 #Z-0643-2025

Product Description

MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;

Reason for Recall

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Details

Units Affected
13057 units
Distribution
US Nationwide distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 3) GYN MAJOR, REF CDS980998L; 4) ROBOTIC PROCEDURE, REF CDS982128P; 5) ROBOTIC, REF CDS984262N; 6) GYN LAPAROSCOPY, REF CDS984900M; 7) GYN LAPAROSCOPY, REF CDS984900N; 8) DAVINCI PACK-LF, REF DYNJ0101304G; 9) PROSTATE ROBOTIC PACK, REF DYNJ0347372J; 10) URO GYN PACK-LF, REF DYNJ17454N; 11) DB DAVINCI ROBOT PACK-LF, REF DYNJ33592I; 12) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 13) TLH PACK, REF DYNJ42792D; 14) SVMMC GEN ROBOTIC PACK, REF DYNJ43770L; 15) SVMMC ROBOTIC KIDNEY PACK, REF DYNJ43778L; 16) SVMMC GYN ROBOTIC PACK, REF DYNJ43782K; 17) SVMMC ROBOTIC PROSTATE PACK, REF DYNJ43862J; 18) DA VINCI HYSTERECTOMY, REF DYNJ44863O; 19) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864S; 20) LAP-GYN PACK, REF DYNJ44876L; 21) LAP-GYN PACK, REF DYNJ44876M; 22) ROBOT PACK, REF DYNJ45184F; 23) GYN ROBOTIC PACK, REF DYNJ47766Q; 24) ST. ANNE'S MULTI PORT PACK, REF DYNJ48638G; 25) RBTC COLON/KIDNEY PK RFID-LF, REF DYNJ52397M; 26) GYN LAP PACK, REF DYNJ52524C; 27) ROBOTIC PACK, REF DYNJ53650D; 28) LAPAROTOMY PACK, REF DYNJ59079D; 29) ROBOTIC GYN PACK, REF DYNJ62107B; 30) GYN UROL BASIC LAPAROSCOPY, REF DYNJ63326D; 31) FAIRFAX DAVINCI TRAY, REF DYNJ63606C; 32) GYN LAP PACK, REF DYNJ64234B; 33) ROBOT GYN SHARED, REF DYNJ64793A; 34) ROBOT GYN SHARED, REF DYNJ64793B; 35) ROBOT GYN SHARED, REF DYNJ64793C; 36) GYN DAVINCI PACK, REF DYNJ65373A; 37) ROBOT PACK, REF DYNJ67190C; 38) TUBAL LIGATION PACK, REF DYNJ68563A; 39) TUBAL LIGATION PACK, REF DYNJ68563B; 40) DAVINCI GYN PACK, REF DYNJ69169A; 41) GYN LAPAROSCOPY PACK, REF DYNJ69490C; 42) ROBOTIC PACK, REF DYNJ84776A; 43) ROBOTIC LAVH, REF DYNJ901281G; 44) ROBOTIC LAP CHOLE, REF DYNJ901282J; 45) GYN LAPAROTOMY, REF DYNJ902498J; 46) WMC ROBOTIC BASE-LF, REF DYNJ902583M; 47) HHI ROBOTIC CDS, REF DYNJ902953G; 48) HHI ROBOTIC CDS, REF DYNJ902953I; 49) HHI ROBOTIC CDS, REF DYNJ902953J; 50) HHI ROBOTIC CDS, REF DYNJ902953K; 51) ROBOTIC GYN & GU, REF DYNJ903459F; 52) SM DAVINCI, REF DYNJ903539G; 53) WEST GYN LAPAROSCOPY, REF DYNJ904490I; 54) ROBOTIC GYN, REF DYNJ904792C; 55) ROBOTIC GENERAL, REF DYNJ904793B; 56) ROBOT, REF DYNJ906112B; 57) ROBOTIC URO LH, REF DYNJ906445A; 58) ROBOTIC URO LH, REF DYNJ906445B; 59) ROBOTIC URO LH, REF DYNJ906445C; 60) WMC THORACIC ROBOTIC, REF DYNJ907153C; 61) DAVINCI, REF DYNJ907392A; 62) DAVINCI, REF DYNJ907392B; 63) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396B; 64) DAVINCI ROBOTICS-HERNIA, REF DYNJ907396C; 65) GYN LAPAROSCOPY - NTSC, REF DYNJ907407A; 66) GYN LAPAROSCOPY - NTSC, REF DYNJ907407B; 67) ROBOTIC-LF, REF DYNJ907910; 68) ROBOTIC-LF, REF DYNJ907910A; 69) GU DAVINCI KIT, REF DYNJ908783; 70) GU DAVINCI KIT, REF DYNJ908783A; 71) GU DAVINCI PACK - LF, REF DYNJ909398A; 72) GYN LAPAROSCOPY, REF DYNJ910084; 73) MHPB GYN ROBOTIC PACK, REF DYNJ910125;. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 13057 units.
Why was this product recalled?
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 11, 2024. Severity: Moderate. Recall number: Z-0643-2025.