Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported December 11, 2024
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
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Medline Industries, LP - Northfield recalled MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN L… - a moderate-severity action.
MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN L… was recalled by Medline Industries, LP - Northfield in December 11, 2024. Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil w…. Check the official notice for the remedy. Verify recall #Z-0643-2025 with the FDA Devices before acting.
The recall
Medline Industries, LP - Northfield issued this moderate-severity FDA Devices recall-Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil w….
- Moderate
- severity level
- 13K units
- affected scope
- Class II
- classification
- December 11, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0643-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0643-2025) was formally reported on December 11, 2024, with the manufacturer initiating the action on October 9, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Medline Industries, LP - Northfield is listed as the recalling firm, operating out of Northfield, IL. Federal records list the affected scope as 13057 units.
The documented reason for this recall is: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
13057 units
Related Recalls
6
3 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-0643-2025 |
| Date reported | December 11, 2024 |
| Date initiated | October 9, 2024 |
| Recalling firm | Medline Industries, LP - Northfield |
| Firm location | Northfield, IL |
| Affected scope | 13057 units |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0643-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0643-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported December 11, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.