Panels › Obstetrics/Gynecology
Obstetrics/Gynecology devices
180 product codes reviewed by the Obstetrics/Gynecology panel. 4,633 510(k) clearances and 812 recalls in the FDA data, 43% of those recalls name a 510(k).
104510(k)s in 12 months
114recalls in 12 months
351recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| OKV | Obstetrical Kit | 95 | 15 |
| OHM | Cesarean Section Tray | 75 | 14 |
| OHD | Gynecological Laparoscopic Kit | 56 | 22 |
| MLS | Labor And Delivery Kit | 47 | 11 |
| HEB | Tampon, Menstrual, Unscented | 36 | 1 |
| MQF | Catheter, Assisted Reproduction | 36 | 0 |
| OJF | Hysterectomy Kit | 30 | 15 |
| HIF | Insufflator, Laparoscopic | 29 | 15 |
| HGM | System, Monitoring, Perinatal | 28 | 5 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 24 | 0 |
| OHG | Circumcision Tray | 20 | 6 |
| HET | Laparoscope, Gynecologic (And Accessories) | 19 | 0 |
| HHW | Pessary, Vaginal | 17 | 0 |
| HIH | Hysteroscope (And Accessories) | 16 | 4 |
| MQL | Media, Reproductive | 15 | 0 |
Active product codes
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| HGX | Pump, Breast, Powered | 2 | 39 | 0 |
| OHD | Gynecological Laparoscopic Kit | 2 | 0 | 22 |
| HIF | Insufflator, Laparoscopic | 2 | 3 | 15 |
| NUC | Lubricant, Personal | 2 | 15 | 0 |
| OJF | Hysterectomy Kit | 2 | 0 | 15 |
| OKV | Obstetrical Kit | 2 | 0 | 15 |
| OHM | Cesarean Section Tray | 2 | 0 | 14 |
| HIH | Hysteroscope (And Accessories) | 2 | 8 | 4 |
| MLS | Labor And Delivery Kit | 2 | 0 | 11 |
| HGM | System, Monitoring, Perinatal | 2 | 2 | 5 |
| OHG | Circumcision Tray | 2 | 0 | 6 |
| HIS | Condom | 2 | 3 | 1 |
| HEB | Tampon, Menstrual, Unscented | 2 | 2 | 1 |
| HIG | Insufflator, Hysteroscopic | 2 | 2 | 1 |
| MQK | Labware, Assisted Reproduction | 2 | 3 | 0 |
| MQL | Media, Reproductive | 2 | 3 | 0 |
| HIB | Speculum, Vaginal, Nonmetal | 2 | 1 | 1 |
| LKF | Cannula, Manipulator/Injector, Uterine | 2 | 2 | 0 |
| MLT | Pelvic Exam Kit | 2 | 0 | 2 |
| MQG | Accessory, Assisted Reproduction | 2 | 2 | 0 |
| HDB | Extractor, Vacuum, Fetal | 2 | 0 | 1 |
| HFX | Clamp, Circumcision | 2 | 1 | 0 |
| HHW | Pessary, Vaginal | 2 | 1 | 0 |
| HIR | Perineometer | 2 | 1 | 0 |
| KNF | Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | 2 | 1 | 0 |
| KNG | Monitor, Ultrasonic, Fetal | 2 | 1 | 0 |
| LHQ | System, Telethermographic (Adjunctive Use) | 1 | 1 | 0 |
| LQK | Home Uterine Activity Monitor | 2 | 1 | 0 |
| MOL | Condom, Synthetic | 2 | 1 | 0 |
| MQE | Needle, Assisted Reproduction | 2 | 1 | 0 |
| MQF | Catheter, Assisted Reproduction | 2 | 1 | 0 |
| MQH | Microtools, Assisted Reproduction (Pipettes) | 2 | 1 | 0 |
| MRX | System, Assisted Reproduction Laser | 2 | 1 | 0 |
| MSC | Barrier, Std, Oral Sex | 2 | 1 | 0 |
| OQY | Intrauterine Tamponade Balloon | 2 | 1 | 0 |
| PBH | Embryo Image Assessment System, Assisted Reproduction | 2 | 1 | 0 |
| PBQ | Fixation, Non-Absorbable Or Absorbable, For Pelvic Use | 2 | 1 | 0 |
| PFJ | Catheter, Balloon, Dilation Of Cervical Canal Prior To Labor | 2 | 1 | 0 |
| PYT | Device, Fertility Diagnostic, Contraceptive, Software Application | 2 | 1 | 0 |
| SIM | Gynecologic Power Morcellator And Containment System | 2 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) C SECTION, ADM, KIT , CATALOG #MA3HD0326B;
2) C SEC Open, Classified |
OHM | None listed |
| Nov 2, 2026 | Cardinal Health 200, LLC Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as:
1) KIT,LABOR KIT, , CATALOG # MA1JV8300C;
2) KIT,LABOR KIT, Open, Classified |
MLS | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G Open, Classified |
OKV | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
ADVANCE LAPAROSCOPIC
DYNJ911135A
CHN GYN ONCOLOGY
DYNJ906731M Open, Classified |
OJF | None listed |
| Oct 15, 2026 | Medline Industries, LP Convenience Kits containing CONMED AirSeal Access Ports
CHN GYN ONCOLOGY
DYNJ906731K
DYNJ906731L
DYNJ906731N
DAVINCI PROSTATECTOMY
DYNJG901002A
DYNJG901002B
DYNJG901002C
Open, Classified |
OHD | None listed |
| Oct 7, 2026 | AVID Medical, Inc. ABD HYSTERECTOMY;
Model/Item Number (Kit): NAMC438-07; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. GYN LAPAROSCOPY PACK;
Model/Item Number (Kit): NAMC436-12; Open, Classified |
OKV | None listed |
| Oct 7, 2026 | AVID Medical, Inc. DAVINCI LAP/GYN;
Model/Item Number (Kit): WRNM037-16; Open, Classified |
OKV | None listed |
| Sep 25, 2026 | Olympus Corporation of the Americas Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A. Open, Classified |
HIH | K890328 |
| Sep 25, 2026 | Olympus Corporation of the Americas Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A. Open, Classified |
HIH | K890328 |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, LAVH , Catalog Number: PB63VHSTC Open, Classified |
OJF | None listed |
| Sep 25, 2026 | Cardinal Health 200, LLC Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets:
1) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLAC;
2) KIT, GYN LAPAROSCOPY NEW HAN , Catalog Number: PB23GLNLA1;
3) Open, Classified |
OHD | None listed |
| Sep 25, 2026 | American Contract Systems Inc Medical convenience kits containing BD CliniClean Pericare Wipes within BD Urinary Catheter Trays
ABDOMINAL HYSTERECTOMY - 205989
Model No. MHAH55AM
LAVH-LAP COLON
Model No. SPLL54U
VAG HYST Open, Classified |
OJF | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) PBCGLVBLI, Catalog Number: KIT, BLO LAVH ;
2) PB15HYFCY, Catalog Number: KIT, UMMC AB HYST II Open, Classified |
OJF | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, ROBOTIC HYST , Catalog Number: PB41RHRM3;
2) KIT, ROBOTIC HYST , Catalog Number: Open, Classified |
OHM | None listed |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT, BLO ROBOTIC GYN , Catalog Number: PBCGRGB28;
2) KIT , GYN MAJOR BARNES JEWIS, Catalog Number: Open, Classified |
OHD | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
C-SECTION PREP
DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
LABOR CDS
CDS981762B
VAG DELIVERY ADMISSION BAG
DYKA1054F Open, Classified |
MLS | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) C-SECTION PREP, Model Number: DYNJ32702B Open, Classified |
OHM | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits:
1) LABOR CDS, Model Number: CDS981762B;
2) VAG DELIVERY ADMISSION BAG, Model Number: DYKA1054F Open, Classified |
MLS | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F;
2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C;
3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B;
Open, Classified |
OKV | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) LAVH, Medline Kit SKU CDS982273U;
2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L;
3) GYN LAP HYSTERECTOMY CDS, Medline Kit SKU CDS982662Q;
4) CMH VAG HYS Open, Classified |
OJF | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) C-SECTION, Medline Kit SKU DYNJ904612L;
2) C-SECTION, Medline Kit SKU DYNJ911755;
3) AHR C-SECTION KIT, Medline Kit SKU DYNJ912014. Open, Classified |
OHM | None listed |
| Aug 26, 2026 | Medline Industries, LP Medline convenience kits labeled as:
1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q;
2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D;
3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759;
4 Open, Classified |
OHD | None listed |
| Aug 14, 2026 | AVID Medical, Inc. Halyard LAVH PACK, Model/Catalog Number: USAR053-11 Open, Classified |
OKV | None listed |
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