Recalls and safety alerts from the FDA, newest first.
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. — Olympus Corporation of the Americas · Class II · Ongoing · 3,663 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 440
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000). — Daavlin Distributing Company · Class II · Ongoing · 26 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 117 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 950
Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub score lines in the hub region. — Oscor Inc. · Class I · Ongoing · 1332 units
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate. — ICU Medical, Inc. · Class II · Ongoing · 5059 units
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 200
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 — Orthofix U.S. LLC · Class II · Ongoing · 32 units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device. — Medline Industries, LP · Class II · Ongoing · 163 kits
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 35,430 units
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 — Orthofix U.S. LLC · Class II · Ongoing · 62 units
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 1,223 units
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. — Medtronic Perfusion Systems · Class II · Ongoing
Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. — Argon Medical Devices, Inc · Class I · Ongoing · 850
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 1,574 units
Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization run (Run ID 1183-28782A) performed by STERIS at its Whippany, NJ facility between March 31 and April 1 of 2026. — Maquet Cardiovascular, LLC · Class II · Ongoing · 205 units
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety pawl may not have been performed to confirm proper assembly. If a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work, causing the arm with X-ray tube and col… — GE Medical Systems, LLC · Class II · Ongoing · 24 units
Unilateral external fixation devices may be incorrectly labeled. Minirail M101 was labeled as M103, Minirail M103 was labeled as M101, and Minirail M122 was labeled as M111 — Orthofix U.S. LLC · Class II · Ongoing · 19 units
Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to sterilize the devices. — Olympus Corporation of the Americas · Class II · Ongoing · 1,156 units
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of product include clinically insignificant extension of surgery to find another readily available device. — Medline Industries, LP · Class II · Ongoing · 163 kits
Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product, which may expose a section of instrument arm, which may result in procedure delay or conversion to an alternate minimally invasive approach. Retrospectively reported recall. — Intuitive Surgical, Inc. · Class II · Ongoing · 11113
Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. — Medtronic Perfusion Systems · Class II · Ongoing
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. These manufacturing issues are not visually detectable by the user, and 14Fr or 23Fr Introducers are provided in every pump set. — Abiomed, Inc. · Class I · Ongoing · 5,017 units