Class IIOngoingZ-2082-2026
DFI Co., Ltd. recalls One Step 10A in vitro diagnostic test
The devices were distributed without required FDA premarket clearance or approval.
DFI Co., Ltd.May 13, 2026
Recalls: No Marketing Application
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 25–36 of 82 recalls
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 IIOngoingZ-1850-2026
Medline Industries, LP recalls Medline Kits: 1) ARTHROSCOPY PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1849-2026
Medline Industries, LP recalls Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1848-2026
Medline Industries, LP recalls Medline Kits: 1) D AND C PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1847-2026
Medline Industries, LP recalls Medline Kits: 1) HYSTEROSCOPY PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1846-2026
Medline Industries, LP recalls Medline Kits: 1) GYN LAPAROSCOPY PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1845-2026
Medline Industries, LP recalls Medline Kits: 1) LABOR PACK-22025208-LF
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1844-2026
Medline Industries, LP recalls Medline Kits: 1) ARTHROGRAM TRAY
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1843-2026
Medline Industries, LP recalls Medline Kits: 1) SYR CONTROL 8ML ROTATING
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1842-2026
Medline Industries, LP recalls Medline Kits: 1) NEWBORN ADMISSION
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026
Class IIOngoingZ-1841-2026
Medline Industries, LP recalls Medline Kits: 1) BREAST PACK
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Industries, LPILApr 29, 2026