Sep 2, 2026
Z-3039-2026
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- 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
Sep 2, 2026
Z-3038-2026
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3037-2026
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3036-2026
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
GE Medical Systems Information Technologies Inc
- MWI
- Class II
- Ongoing
Sep 2, 2026
Z-3035-2026
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Olympus Corporation of the Americas
- GEI
- Class II
- Ongoing
Sep 2, 2026
Z-3034-2026
ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000 and 114093-600
IMRIS Imaging Inc
- KXJ
- Class II
- Ongoing
Sep 2, 2026
Z-3033-2026
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 P…
IMRIS Imaging Inc
- FQO
- Class II
- Ongoing
Sep 2, 2026
Z-3032-2026
healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Test, Model Number PT-SQ-001
Healthmark Industries Co., Inc.
- SDC
- Class II
- Ongoing
Sep 2, 2026
Z-3031-2026
healthmark ProChek-II, Model Number PT-313, PT-201-12
Healthmark Industries Co., Inc.
- SDC
- Class II
- Ongoing
Sep 2, 2026
Z-3030-2026
FUJIFILM Synapse PACS software v7.4.310; radiological image processing system
FUJIFILM Healthcare Americas Corporation
- LLZ
- Class II
- Ongoing
Sep 2, 2026
Z-3029-2026
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Med…
Medline Industries, LP
- OJH
- Class II
- Ongoing
Sep 2, 2026
Z-3028-2026
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 LAPAR…
Medline Industries, LP
- OKV
- Class II
- Ongoing
Sep 2, 2026
Z-3027-2026
Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABDOMINAL CDS, Medline Kit SKU CDS982654L; 3) GYN LAP HYSTERECTOMY CDS, Medlin…
Medline Industries, LP
- OJF
- Class II
- Ongoing
Sep 2, 2026
Z-3026-2026
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…
Medline Industries, LP
- OHM
- Class II
- Ongoing
Sep 2, 2026
Z-3025-2026
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 ROBO…
Medline Industries, LP
- OHD
- Class II
- Ongoing
Sep 2, 2026
Z-3024-2026
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Med…
Medline Industries, LP
- LRO
- Class II
- Ongoing
Sep 2, 2026
Z-3023-2026
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Medline Industries, LP
- FTN
- Class II
- Ongoing
Sep 2, 2026
Z-3022-2026
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY,…
Medline Industries, LP
- FDE
- Class II
- Ongoing
Sep 2, 2026
Z-3021-2026
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Medline Industries, LP
- OGR
- Class II
- Ongoing
Sep 2, 2026
Z-3020-2026
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, M…
Medline Industries, LP
- OEZ
- Class II
- Ongoing
Sep 2, 2026
Z-3019-2026
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Medline Industries, LP
- OES
- Class II
- Ongoing
Sep 2, 2026
Z-3018-2026
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures…
ConMed Corporation
- MAI
- Class II
- Ongoing
Sep 2, 2026
Z-3017-2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Fresenius Medical Care Renal Therapies Group, LLC
- KDI
- Class II
- Ongoing
Sep 2, 2026
Z-3016-2026
Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes: 1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145 2) 949-…
Henry Schein Inc.
- EBF
- Class II
- Ongoing
Sep 2, 2026
Z-3015-2026
Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429 2) 114-3934, Mfr Product Code 148…
Henry Schein Inc.
- EBF
- Class II
- Ongoing