Oct 28, 2026
Z-0123-2027
VOCSN+Pro (Japan), Model Number: PRT-00490-100, Package PN:PRT-00853-100. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Oct 28, 2026
Z-0122-2027
VOCSN+Pro, Model Number:PRT-00490-001, Package PN:PRT-00853-000. used for ventilatory support.
Ventec Life Systems, Inc.
- CBK
- Class I
- Ongoing
Oct 21, 2026
Z-0190-2027
The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a labo…
Radiometer Medical ApS
- CHL
- Class II
- Ongoing
Oct 21, 2026
Z-0189-2027
Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395A
Medline Industries, LP
- KCY
- Class II
- Ongoing
Oct 21, 2026
Z-0188-2027
Vinyl Instrument Guards, labeled as: 1) VENTED INSTRUMENT GUARD 1/16 X 3/4H - WHITE, Model Number 09-1-011; 2) WHITE VENTED INSTRUMENT GUARD 1/16 X 3/4, Model…
Healthmark Industries Co., Inc.
- MDM
- Class II
- Ongoing
Oct 21, 2026
Z-0187-2027
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Ste…
Merit Medical Systems, Inc.
- NEU
- Class II
- Ongoing
Oct 21, 2026
Z-0186-2027
IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50…
INTELERAD MEDICAL SYSTEMS INCORPORATED
- LLZ
- Class II
- Ongoing
Oct 21, 2026
Z-0185-2027
Convenience Kits containing CONMED AirSeal Access Ports KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116G
Medline Industries, LP
- OKV
- Class II
- Ongoing
Oct 21, 2026
Z-0184-2027
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
Medline Industries, LP
- OJF
- Class II
- Ongoing
Oct 21, 2026
Z-0183-2027
Convenience Kits containing CONMED AirSeal Access Ports CHN GYN ONCOLOGY DYNJ906731K DYNJ906731L DYNJ906731N DAVINCI PROSTATECTOMY DYNJG901002A DYNJG901002B DY…
Medline Industries, LP
- OHD
- Class II
- Ongoing
Oct 21, 2026
Z-0182-2027
Convenience Kits containing CONMED AirSeal Access Ports GENERAL DAVINCI DYNJG901004C LAP CHOLE DYNJ88071 ROBOTIC PACK DYNJ50474F
Medline Industries, LP
- LRO
- Class II
- Ongoing
Oct 21, 2026
Z-0181-2027
Convenience Kits containing CONMED AirSeal Access Ports HERNANDEZ DAVINCI ACC BUNDLE M DYNJ911258 KIT ROBOTICS UROLOGY PROSTATE DYKMBNDL116I ROBOTIC CHEST DYNJ…
Medline Industries, LP
- LRO
- Class II
- Ongoing
Oct 21, 2026
Z-0180-2027
Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135 LAP CHOLE DYNJ911660 LAP NISSEN DYNJ911560 UROLOGY LAPAROSCOPIC - 51638…
Medline Industries, LP
- FDE
- Class II
- Ongoing
Oct 21, 2026
Z-0179-2027
Medline surgical convenience kits labeled as: 1) SPINAL CDS, Medline Product Number/SKU CDS940087AM; 2) CUSTOM CRANI, Medline Product Number/SKU DYNJ907697C; 3…
Medline Industries, LP
- OJH
- Class II
- Ongoing
Oct 21, 2026
Z-0178-2027
Medline surgical convenience kits labeled as: OPEN HEART, Medline Product Number/SKU DYNJ902898D
Medline Industries, LP
- OJK
- Class II
- Ongoing
Oct 21, 2026
Z-0177-2027
Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU…
Medline Industries, LP
- OJG
- Class II
- Ongoing
Oct 21, 2026
Z-0176-2027
Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Produc…
Medline Industries, LP
- LRO
- Class II
- Ongoing
Oct 21, 2026
Z-0175-2027
Medline surgical convenience kits labeled as: 1) CV BASIN PACK-LF, Medline Product number/SKU DYNJ0538615K; 2) CV BASIN PACK-LF, Medline product number/SKU DYN…
Medline Industries, LP
- KDD
- Class II
- Ongoing
Oct 21, 2026
Z-0174-2027
Medline surgical convenience kits labeled as: 1) MAIN/LAPAROSCOPY TRANSPLA PACK, Medline product number/SKU DYNJ0656274AC; 2) MAIN/LAPAROSCOPY TRANSPLA PACK, M…
Medline Industries, LP
- FDE
- Class II
- Ongoing
Oct 21, 2026
Z-0173-2027
Medline surgical convenience kits labeled as: 1) EAR, Medline product number/SKU DYNJ909020B; 2) EAR, Medline product number/SKU DYNJ909020A; 3) CAROTID PACK,…
Medline Industries, LP
- OGR
- Class II
- Ongoing
Oct 21, 2026
Z-0172-2027
Medline surgical convenience kits labeled as: VEIN HARVESTING PACK, Medline product number/SKU DYNJ51845D
Medline Industries, LP
- OFG
- Class II
- Ongoing
Oct 21, 2026
Z-0171-2027
Medline surgical convenience kits labeled as: 1) VEIN HARVESTING PACK-LF, Medline product number/SKU DYNJ0826732J; 2) NBMC VASCULAR PACK-LF, Medline product nu…
Medline Industries, LP
- OFF
- Class II
- Ongoing
Oct 21, 2026
Z-0170-2027
Medline surgical convenience kits labeled as: 1) OPEN HEART CDS, Medline product number/SKU CDS840094R; 2) OPEN HEART CDS, Medline product number/SKU CDS840171…
Medline Industries, LP
- OEZ
- Class II
- Ongoing
Oct 21, 2026
Z-0169-2027
1) Product Name AUD OPEN HEART PACK, Medline Kit Number/SKU DYNJ22052I; 2) Product Name AV SHUNT PACK-MARYVIEW, Medline Kit Number/SKU DYNJ24528N; 3) Product N…
Medline Industries, LP
- OES
- Class II
- Ongoing
Oct 21, 2026
Z-0168-2027
Medline surgical convenience kits labeled as: CABG AUXILIARY PACK, Medline Product Number/SKU DYNJ44925D
Medline Industries, LP
- OEQ
- Class II
- Ongoing