Class IIOngoingZ-1943-2026
Healthmark Industries Co., Inc. recalls Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Product does not have FDA clearance.
Healthmark Industries…MIMay 6, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 613–624 of 3,866 recalls
Class IIOngoingZ-1941-2026
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Diversatek HealthcareWIApr 29, 2026
Class IIOngoingZ-1940-2026
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Diversatek HealthcareWIApr 29, 2026
Class IIOngoingZ-1939-2026
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Diversatek HealthcareWIApr 29, 2026
Class IIOngoingZ-1938-2026
Diversatek Healthcare recalls Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
Diversatek HealthcareWIApr 29, 2026
Class IIOngoingZ-1937-2026
Foundation Medicine, Inc. recalls Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within…
Potential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for AutoLys Hamilton STAR.
- Somatic Or Germline Variant Detection System Next Generation Sequencing Oncology Panel
- Software change control
Foundation Medicine, I…MAApr 29, 2026
Class IIOngoingZ-1933-2026
LSL Healthcare Inc. recalls LSL Healthcare Wound Closure Tray
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
Class IIOngoingZ-1932-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
Class IIOngoingZ-1931-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
Class IIOngoingZ-1930-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
Class IIOngoingZ-1929-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026
Class IIOngoingZ-1928-2026
LSL Healthcare Inc. recalls LSL Healthcare
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
LSL Healthcare Inc.ILApr 29, 2026