Oct 21, 2026
Z-0141-2027
Brand Name: IOMAX Product Name: IOMAX Cortical Module Model/Catalog Number: 190296-200 UDI-DI code: 00840067100653 Product Description: The IOMAX Cortical Modu…
Cadwell Industries Inc
- GWF
- 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
Oct 21, 2026
Z-0140-2027
BD Phoenix Panel NMIC-306. Catalog Number: 449292.
Becton Dickinson & Co.
- LON
- Class II
- Ongoing
Oct 21, 2026
Z-0139-2027
BD Phoenix Panel NMIC-312. Catalog Number: 449082.
Becton Dickinson & Co.
- LON
- Class II
- Ongoing
Oct 21, 2026
Z-0138-2027
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft…
Medtronic Sofamor Danek USA Inc
- MBP
- Class II
- Ongoing
Oct 21, 2026
Z-0137-2027
Grafton" DBM and Grafton Plus" DBM contain demineralized human bone tissue combined with an inert additive to yield a demineralized bone matrix (DBM) allograft…
Medtronic Sofamor Danek USA Inc
- MBP
- Class II
- Ongoing
Oct 21, 2026
Z-0136-2027
JenaValve Trilogy Delivery Catheter, Size 27MM REF: TRILOGY-DC-L
Jenavalve Technology Inc.
- NPT
- Class II
- Ongoing
Oct 21, 2026
Z-0135-2027
JenaValve Trilogy Delivery Catheter, Size 25MM REF: TRILOGY-DC-M
Jenavalve Technology Inc.
- NPT
- Class II
- Ongoing
Oct 21, 2026
Z-0134-2027
JenaValve Trilogy Delivery Catheter, Size 23MM REF: TRILOGY-DC-S
Jenavalve Technology Inc.
- NPT
- Class II
- Ongoing
Oct 21, 2026
Z-0002-2027
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)
Instrumentation Laboratory
- LCO
- Class I
- Ongoing
Oct 21, 2026
Z-0001-2027
HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic
Instrumentation Laboratory
- LCO
- Class I
- Ongoing
Oct 14, 2026
Z-0119-2027
Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF:…
Intellijoint Surgical, Inc.
- OLO
- Class II
- Ongoing
Oct 14, 2026
Z-0118-2027
HexaVue Focus Integration System, a single, all-in-one system that handles operating room video routing, surgical video integration, and environmental control,…
Steris Corporation
- FTA
- Class II
- Ongoing
Oct 14, 2026
Z-0117-2027
TufTex¿ Over-the-Wire Embolectomy Catheter; Catalog Number: E1651-88;
LeMaitre Vascular, Inc.
- DXE
- Class II
- Ongoing
Oct 14, 2026
Z-0116-2027
T1 Patient Monitor. Operator's Manual: T1 Patient Monitor
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0115-2027
cPM Series Patient Monitor. Operator's Manual: cPM 8/cPM 12
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0114-2027
Passport Series Patient Monitor. Operator's Manuals: 8 / 12 / 12M / 17M / V
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0113-2027
BeneView Series. Operator's Manuals: T5 / T8
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0112-2027
Panorama and Telemetry Monitoring System. Operator's Manuals: TMS-6016/Panorama Telepack-608/TMS60 (TD60).
Mindray DS USA, Inc.
- MSX
- Class III
- Ongoing
Oct 14, 2026
Z-0111-2027
BeneVision Series Telemetry Monitor. Operator's Manuals: TM70/TM80
Mindray DS USA, Inc.
- MSX
- Class III
- Ongoing
Oct 14, 2026
Z-0110-2027
BeneVision N1 and N-Series Patient Monitor. Patient Monitor: N12/N15/N17/N19/N22.
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0109-2027
ePM Series Patient Monitor. Patient Monitor Series: ePM 10M/ePM 12M/ePM 12MA/ ePM 15M/ePM 10A
Mindray DS USA, Inc.
- MHX
- Class III
- Ongoing
Oct 14, 2026
Z-0108-2027
Alphenix INFX-8000C/B5
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Oct 14, 2026
Z-0107-2027
SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC
- JPH
- Class II
- Ongoing
Oct 14, 2026
Z-0106-2027
ABD HYSTERECTOMY; Model/Item Number (Kit): NAMC438-07;
AVID Medical, Inc.
- OKV
- Class II
- Ongoing
Oct 14, 2026
Z-0105-2027
GYN LAPAROSCOPY PACK; Model/Item Number (Kit): NAMC436-12;
AVID Medical, Inc.
- OKV
- Class II
- Ongoing