Nov 4, 2026
Z-0293-2027
Philips Azurion 3 M15. Model Number: 722064, 722222, 722280.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- 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.
75 records
Nov 4, 2026
Z-0292-2027
Philips Azurion 3 M12. Model Numbers: 722063, 722221.
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0291-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000V
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0290-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000F
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0289-2027
ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C
Canon Medical System, USA, INC.
- OWB
- Class II
- Ongoing
Nov 4, 2026
Z-0288-2027
Model Number: 712010.
Philips North America
- IZL
- Class II
- Ongoing
Nov 4, 2026
Z-0286-2027
Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020
ZIEHM-ORTHOSCAN INC
- OXO
- Class II
- Ongoing
Nov 4, 2026
Z-0285-2027
OmniaSecure Model 3930M, LEAD 3930M74 74 CM DF4 MR 3930M74 LEAD 3930M79 79 CM DF4 MR 3930M79 The Medtronic OmniaSecure" Model 3930M lead is a steroid eluting,…
Medtronic, Inc.
- NVY
- Class II
- Ongoing
Nov 4, 2026
Z-0284-2027
ETHILON Nylon Suture, Product Code 697G
Ethicon, LLC
- GAQ
- Class II
- Ongoing
Nov 4, 2026
Z-0210-2027
Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Nov 4, 2026
Z-0209-2027
Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Nov 4, 2026
Z-0208-2027
Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.
Abiomed, Inc.
- OZD
- Class I
- Ongoing
Nov 3, 2026
Z-0356-2027
Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040.
CORIN MEDICAL, LTD.
- JWH
- Class II
- Open, Classified
Nov 3, 2026
Z-0355-2027
Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Remel, Inc
- NGZ
- Class II
- Open, Classified
Nov 3, 2026
Z-0354-2027
TruSystem 7500 Hybrid Plus (FC), Fixed-Installation Operating Table Column, Model/Catalog Number: 1854087
Baxter Healthcare Corporation
- GDC
- Class I
- Open, Classified
Nov 3, 2026
Z-0353-2027
Operating Table TruSystem 7000 U (dV), Model/Catalog Number: 1723633
Baxter Healthcare Corporation
- GDC
- Class I
- Open, Classified
Nov 3, 2026
Z-0352-2027
Operating Table TruSystem 7000 U, Surgical table, universal, Model/Catalog Number: 1604788
Baxter Healthcare Corporation
- GDC
- Class I
- Open, Classified
Nov 3, 2026
Z-0351-2027
Operating table column TS7500 MOBIUS, Hybrid operating table column, Model/Catalog Number: 1704695
Baxter Healthcare Corporation
- GDC
- Class I
- Open, Classified
Nov 3, 2026
Z-0350-2027
TruSystem 7500 surgical table, Model/Catalog Number: 4091000
Baxter Healthcare Corporation
- GDC
- Class I
- Open, Classified
Nov 3, 2026
Z-0349-2027
Cochlear Nucleus Nexa cochlear implant with Contour Advance electrode REF P1979576 Model Number: CI1000 UDI-DI codes: 9321502069847 Cochlear Nucleus CI1000 Ser…
Cochlear Limited
- MCM
- Class III
- Open, Classified
Nov 3, 2026
Z-0348-2027
Veritas Reverse Total Shoulder Replacement, Model/Catalog Number: 3500-140C3, 3500-140U3, 3500-140C1, 3500-140U1, size 1 -2, 40mm Polymer Liner
restor3d Inc.
- PHX
- Class II
- Open, Classified
Nov 3, 2026
Z-0347-2027
Trinias Opera Smart (C16s, F12s)/Opera Grand(C12s,C16s, F12s)/Smart OBL Interventional Fluoroscopic X-Ray System containing C-arm support (MH-500, MH-60),
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
- OWB
- Class II
- Open, Classified
Nov 3, 2026
Z-0346-2027
Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8695P (HSI Item No. 600-9795); Product D…
Henry Schein Inc.
- GAW
- Class II
- Open, Classified
Nov 3, 2026
Z-0345-2027
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Product Description: St…
Henry Schein Inc.
- GAM
- Class II
- Open, Classified
Nov 3, 2026
Z-0344-2027
Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN392V (HSI Item No. 600-9613); Product Description: St…
Henry Schein Inc.
- GAM
- Class II
- Open, Classified