Class IOngoingZ-2684-2026
Abiomed, Inc. recalls ABIOMED Introducer Kit 23 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Recalls: Under Investigation by firm
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 85–96 of 1,213 recalls
Class IOngoingZ-2683-2026
Abiomed, Inc. recalls ABIOMED Impella CP Introducer Kit 14 Fr
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2682-2026
Abiomed, Inc. recalls ABIOMED Impella CP Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IOngoingZ-2681-2026
Abiomed, Inc. recalls ABIOMED Impella RP Flex with SmartAssist Set
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.…
Abiomed, Inc.MAJul 22, 2026
Class IIOngoingZ-2703-2026
Siemens Healthcare Diagnostics, Inc. recalls Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
The potential for intermittent well-to-well bias on the A1c_E assay on the Atellica CH and Atellica CI analyzer which could cause falsely depressed or falsely elevated HbA1c patient results.
Siemens Healthcare Dia…NYJul 15, 2026
Class IIOngoingZ-2697-2026
Medline Industries, LP recalls Medline Convenience Kits: 1) OPEN HEART PEDS PACK
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9…
Medline Industries, LPILJul 15, 2026
Class IIOngoingZ-2696-2026
Medline Industries, LP recalls Medline Convenience Kits: 1) OPEN HEART PEDS PACK
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9…
Medline Industries, LPILJul 15, 2026
Class IIOngoingZ-2695-2026
Medline Industries, LP recalls Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm general purpose temperature probe-size 9…
Medline Industries, LPILJul 15, 2026
Class IIOngoingZ-2674-2026
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
Zimmer Surgical IncOHJul 8, 2026
Class IIOngoingZ-2673-2026
Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…
Zimmer Surgical IncOHJul 8, 2026
Class IIOngoingZ-2672-2026
W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…
Due to catheter separation
W L Gore & Associates,…AZJul 8, 2026
Class IIOngoingZ-2654-2026
BD SWITZERLAND SARL recalls MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM246…
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
BD SWITZERLAND SARLJul 8, 2026