Class IIOngoingZ-3333-2026
Karl Storz Endoscopy recalls HOPKINS Telescope 30¿
Due to incorrect inside packaging label for eyepiece.
Karl Storz EndoscopyCAOct 7, 2026
Recalls: Employee error
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 18 recalls
Class IIOngoingZ-3147-2026
Bayer Medical Care, Inc. recalls MEDRAD¿ Stellant FLEX Syringe Kit used with Stellant FLEX CT Injection System
Some devices may not have been properly sterilized due to a manufacturing sterilization issue.
Bayer Medical Care, In…PASep 23, 2026
Class IIOngoingZ-2649-2026
Carl Zeiss Meditec AG recalls Zeiss Intrabeam Spherical Applicator 1.5 cm REF:304534-6000-557
Spherical applicators (radiation therapy accessory) failed to meet manufacturing specifications.
Carl Zeiss Meditec AGJul 8, 2026
Class IIOngoingZ-1368-2026
Baxter Healthcare Corporation recalls Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 So…
Pumps were released without full testing being performed, including occlusion alarm testing.
Baxter Healthcare Corp…ILFeb 25, 2026
Class IIOngoingZ-1298-2026
Wilson-Cook Medical Inc. recalls Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
Wilson-Cook Medical In…NCFeb 11, 2026
Class IIOngoingZ-1256-2026
Vortex Surgical Inc. recalls Vortex Surgical Lindsell Sutured IOL Marker
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1255-2026
Vortex Surgical Inc. recalls Vortex Surgical 25GA Backflush
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1254-2026
Vortex Surgical Inc. recalls Vortex Surgical TID Pharos Illuminated Depressor
XXX
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1253-2026
Vortex Surgical Inc. recalls Rumex Disposable Diamond Dusted ILM Elevator
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1252-2026
Vortex Surgical Inc. recalls Vortex Surgical I2 Injection Kit
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1251-2026
Vortex Surgical Inc. recalls Tecfen Retractable Membrane Polisher
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026
Class IIOngoingZ-1250-2026
Vortex Surgical Inc. recalls Vortex Surgical 25GA I.D.D. Internal Delivery Device
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Vortex Surgical Inc.MOFeb 11, 2026