Class II FDA device recall · Z-0646-2025

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2) LAVH CDS, REF CDS983411J; 3) MAJOR VAGINAL, REF CDS983497L; 4) DAY SURG LARGE VAG CDS, REF CDS984995N; 5) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 6) D&C/HYSTEROSCOPY PACK, REF DYNJ01921M; 7) HYSTERECTOMY PACK-LF, REF DYNJ0488471K; 8) VAG HYST PACK-LF, REF DYNJ0532873M; 9) VAG HYST PACK-LF, REF DYNJ0532873N; 10) VAGINAL PROCEDURES PACK-LF, REF DYNJ0750737Q; 11) MINOR VAGINAL #76-RF, REF DYNJ27434R; 12) DB VAG HYSTERECTOMY-LF, REF DYNJ33590I; 13) VAG HYST PACK, REF DYNJ36628L; 14) VAG HYST PACK, REF DYNJ36628M; 15) ROBOTIC HYSTO URO PACK, REF DYNJ40623F; 16) ABDOMINAL HYST PACK, REF DYNJ44848L; 17) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 18) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900O; 19) VAGINAL HYSTERECTOMY PACK, REF DYNJ44900P; 20) URO GYN, REF DYNJ50047G; 21) LAVH NEW BRAUNFELS, REF DYNJ61136D; 22) ABDOMINAL PERINEAL, REF DYNJ63371D; 23) ABDOMINAL HYST FFX, REF DYNJ63631A; 24) VAGINAL HYSTERECTOMY PACK, REF DYNJ67194B; 25) LAVH PACK, REF DYNJ67210A; 26) VAG MINOR PACK, REF DYNJ82216; 27) VAG MINOR PACK, REF DYNJ82216B; 28) ABDOMINAL HYSTERECTOMY, REF DYNJ900091F; 29) VAGINAL, REF DYNJ900292K; 30) GYN LAPAROTOMY, REF DYNJ900296J; 31) LAVH, REF DYNJ900298J; 32) LAVH, REF DYNJ900298K; 33) LITHOTOMY-LF, REF DYNJ900721C; 34) MAJOR VAGINAL-LF, REF DYNJ901807I; 35) ABDOMINAL HYSTERECTOMY, REF DYNJ906478F; 36) VAGINAL HYST, REF DYNJ907220A; 37) PRENTICE GYNE ONCOLOGY KIT, REF DYNJ908792; 38) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795; 39) PRENTICE TOTAL ABD HYST KIT, REF DYNJ908795B; 40) PRENTICE VAG HYST KIT, REF DYNJ908796; 41) PRENTICE VAG HYST KIT, REF DYNJ908796B; 42) KIT LAVH CENTRAL DUPAGE, REF DYNJ908825; 43) KIT PFANNENSTIEL GYN, REF DYNJ908826; 44) KIT VAGINAL HYSTERECTOMY, REF DYNJ908837

Why it was recalled

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

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

85OJF 1) REF CDS760056G, UDI/DI 10195327009656 (each) 40195327009657 (case), Lot Numbers:  24BBQ489, 23KBP697;  2) REF CDS983411J, UDI/DI 10195327150273 (each) 40195327150274 (case), Lot Numbers:  22LDA249, 23CDB670, 23JDA480, 23IDA660;  3) REF CDS983497L, UDI/DI 10195327560980 (each) 40195327560981 (case), Lot Numbers:  24ADA431, 24BDB524;  4) REF CDS984995N, UDI/DI 10195327587963 (each) 40195327587964 (case), Lot Numbers:  24GBH834, 24EBL666, 24ABA667, 24DBI833, 24CBU970, 24CBJ697;  5) REF DYNJ0160684F, UDI/DI 10195327304287 (each) 40195327304288 (case), Lot Numbers:  22LDB323, 22LDC130, 23CDA546;  6) REF DYNJ01921M, UDI/DI 10195327491673 (each) 40195327491674 (case), Lot Numbers:  23IBT540;  7) REF DYNJ0488471K, UDI/DI 10195327046064 (each) 40195327046065 (case), Lot Numbers:  22EBG378, 23CBQ258, 23CBA485, 23KBC614, 23HBP501, 23JBT064, 23IBV599;  8) REF DYNJ0532873M, UDI/DI 10195327083465 (each) 40195327083466 (case), Lot Numbers:  22FMH645, 22HMF692;  9) REF DYNJ0532873N, UDI/DI 10195327249694 (each) 40195327249695 (case), Lot Numbers:  23DMD053;  10) REF DYNJ0750737Q, UDI/DI 10195327196783 (each) 40195327196784 (case), Lot Numbers:  23FMC422;  11) REF DYNJ27434R, UDI/DI 10195327107727 (each) 40195327107728 (case), Lot Numbers:  22EBR089, 23ABM013, 23CBX286;  12) REF DYNJ33590I, UDI/DI 10195327469542 (each) 40195327469543 (case), Lot Numbers:  23JDA425, 23GDB694, 23JDA783;  13) REF DYNJ36628L, UDI/DI 10193489437188 (each) 40193489437189 (case), Lot Numbers:  22HMF864, 23EMB913;  14) REF DYNJ36628M, UDI/DI 10195327437268 (each) 40195327437269 (case), Lot Numbers:  23LMC975, 23LMC305, 24AMC175, 23FMD871;  15) REF DYNJ40623F, UDI/DI 10195327435783 (each) 40195327435784 (case), Lot Numbers:  23IBR215;  16) REF DYNJ44848L, UDI/DI 10195327127565 (each) 40195327127566 (case), Lot Numbers:  22IDA312, 22LDB966;  17) REF DYNJ44863Q, UDI/DI 10195327298227 (each) 40195327298228 (case), Lot Numbers:  23ADA450, 23CDC113, 23CDA613, 23BDA189;  18) REF DYNJ44900O, UDI/DI 10195327127770 (each) 40195327127771 (case), Lot Numbers: 22HDB535, 22KDB315;  19) REF DYNJ44900P, UDI/DI 10195327298548 (each) 40195327298549 (case), Lot Numbers:  22KDB784, 22LDA872, 22LDB908, 23DDA086;  20) REF DYNJ50047G, UDI/DI 10195327107734 (each) 40195327107735 (case), Lot Numbers:  22FBN014, 22LBP709, 23DBJ770, 23CBF613;  21) REF DYNJ61136D, UDI/DI 10195327470302 (each) 40195327470303 (case), Lot Numbers:  23IBN858;  22) REF DYNJ63371D, UDI/DI 10193489983784 (each) 40193489983785 (case), Lot Numbers:  22DBL296, 22FBS033;  23) REF DYNJ63631A, UDI/DI 10193489900309 (each) 40193489900300 (case), Lot Numbers:  22HBC445, 22FBR617, 22LBD142, 23BBQ558, 23GBC822, 23GBT620, 23JBL757;  24) REF DYNJ67194B, UDI/DI 10195327299699 (each) 40195327299690 (case), Lot Numbers:  23ABQ738;  25) REF DYNJ67210A, UDI/DI 10195327150532 (each) 40195327150533 (case), Lot Numbers:  22GBY195, 22GBO568;  26) REF DYNJ82216, UDI/DI 10195327183769 (each) 40195327183760 (case), Lot Numbers:  23HMI516;  27) REF DYNJ82216B, UDI/DI 10195327534820 (each) 40195327534821 (case), Lot Numbers:  23JMG567;  28) REF DYNJ900091F, UDI/DI 10195327075613 (each) 40195327075614 (case), Lot Numbers:  23ABM839, 23HBA598, 23JBR356, 23HBV298, 23IBP601;  29) REF DYNJ900292K, UDI/DI 10193489915730 (each) 40193489915731 (case), Lot Numbers:  22GBK158, 22FBL459, 23DBA365, 22LBH130, 22LBC401, 23EBT068;  30) REF DYNJ900296J, UDI/DI 10193489915754 (each) 40193489915755 (case), Lot Numbers:  22GBT650, 23DBA294, 23EBG706;  31) REF DYNJ900298J, UDI/DI 10193489915167 (each) 40193489915168 (case), Lot Numbers:  22EBB287, 22DBT480, 23DBD352, 22LBC402, 22KBW389;  32) REF DYNJ900298K, UDI/DI 10195327373337 (each) 40195327373338 (case), Lot Numbers:  23GBM311;  33) REF DYNJ900721C, UDI/DI 10193489951608 (each) 40193489951609 (case), Lot Numbers:  22EBO945, 22HBE990, 23ABQ354, 22LBE624, 22KBC673, 23EBV945;  34) REF DYNJ901807I, UDI/DI 10195327496166 (each) 40195327496167 (case), Lot Numbers:  23KDB594, 23IDC225, 24CDB873, 24BDB761;  35) REF DYNJ906478F, UDI/DI 10195327202675 (each) 40195327202676 (case), Lot Numbers:  23GDB463, 23IDB304;  36) REF DYNJ907220A, UDI/DI 10195327329648 (each) 40195327329649 (case), Lot Numbers:  23BME638;  37) REF DYNJ908792, UDI/DI 10195327183264 (each) 40195327183265 (case), Lot Numbers:  23CDA683;  38) REF DYNJ908795, UDI/DI 10195327183288 (each) 40195327183289 (case), Lot Numbers:  23DDB794, 23FDB261, 23JDB336;  39) REF DYNJ908795B, UDI/DI 10195327535049 (each) 40195327535040 (case), Lot Numbers:  24AMA320, 24BMK237, 24AMH044;  40) REF DYNJ908796, UDI/DI 10195327183271 (each) 40195327183272 (case), Lot Numbers:  23IDA364, 23EDA172;  41) REF DYNJ908796B, UDI/DI 10195327535056 (each) 40195327535057 (case), Lot Numbers:  23LMF165;  42) REF DYNJ908825, UDI/DI 10195327185121 (each) 40195327185122 (case), Lot Numbers:  23BDA825, 23EDC464;  43) REF DYNJ908826, UDI/DI 10195327185145 (each) 40195327185146 (case), Lot Numbers:  22LDA975;  44) REF DYNJ908837, UDI/DI 10195327185169 (each) 40195327185160 (case), Lot Numbers:  23IDB086, 23JDA593, 23HDB464, 23HDB110

Recall status

Ongoing — the recall is still being carried out.

Where it was distributed

US Nationwide distribution.

Recall record

Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product type: Devices
Recall number: Z-0646-2025
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Origin: Northfield, IL
Recall initiated: 2024-10-09

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall Z-0646-2025 · Source: openFDA enforcement.