Class IOngoingZ-2593-2025
Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) EXTREMITY PACK
Convenience kits labeled as sterile have not gone through the sterilization process.
Medline Industries, LPILOct 8, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 493–504 of 822 recalls
Class IOngoingZ-2592-2025
Medline Industries, LP recalls Sterile Medline Convenience Kits: 1) MAJOR PACK L-F
Convenience kits labeled as sterile have not gone through the sterilization process.
Medline Industries, LPILOct 8, 2025
Class IIOngoingZ-0027-2026
Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD LONG. Model Number: GB943R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Aesculap AGOct 8, 2025
Class IIOngoingZ-0026-2026
Aesculap AG recalls AESCULAP ELAN 4 FIXED DURAGUARD STANDARD. Model Number: GB942R.
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
Aesculap AGOct 8, 2025
Class IIOngoingZ-0025-2026
Northeast Scientific Inc. recalls NES Reprocessed 2.0mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0024-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.7mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0023-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.4mm RX Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-15…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0022-2026
Northeast Scientific Inc. recalls NES Reprocessed 0.9mm RX Turbo Elite Laser Atherectomy Catheter. Model/Catalog Number:…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0021-2026
Northeast Scientific Inc. recalls NES Reprocessed 2.0mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-420-0…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0020-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-417-1…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0019-2026
Northeast Scientific Inc. recalls NES Reprocessed 1.4mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-414-1…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025
Class IIOngoingZ-0018-2026
Northeast Scientific Inc. recalls NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter. Model Number: R-410-1…
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Northeast Scientific I…CTOct 8, 2025