The latest headlines across every section, pulled from official and open-access sources.
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 11, 977 units
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator — CareFusion 213, LLC · Class II · Ongoing · 43,066,599 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 1,201 units
Subpotent Drug: Low out of specification assay results performed during long-term stability testing. — Padagis US LLC · Class II · Ongoing · 180,936 tubes
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 993 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 106,301 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 16,156 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 5,762 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 20, 160 units
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). — Bell Pharmaceuticals, Inc · Class II · Ongoing · 31,094 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 · 48 units
Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. There is a risk of syringe loosening or disconnecting from the manifold, resulting in loose connection or complete disconnection. May lead to difficulty connecting syringe, inability to aspirate or inject properly, fluid leakage, or separation of the syringe from th… — Boston Scientific Corporation · Class II · Ongoing · 153,921 (US); 119,274 (OUS)
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 · 87,277 units
Potential for brush heads to break. — Papablic Inc · Class II · Ongoing · 13,400 packs
Potential for brush heads to break. — Papablic Inc · Class II · Ongoing · 14,700 packs
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 · 1,540 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 · 12525 units
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 · 212 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 · 4 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 · 846 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 · 3,241 units
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 · 355 units
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 · 2 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 · 38 units