The latest headlines across every section, pulled from official and open-access sources.
Presence of Particulate Matter: Hair was found in product — Fresenius Kabi USA, LLC · Class II · Ongoing · 59,425 vials
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Presence of Precipitate: medication was crystallizing and particles floating in the bottle — Rising Pharma Holding, Inc. · Class II · Ongoing · 74208 units
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 1.033,266 cartons
Subpotent Drug — Major Pharmaceuticals · Class II · Ongoing · N/A
Lack of Assurance of Sterility — Rohto-Mentholatum (Vietnam) Co., Ltd. · Class II · Ongoing · 353 cartons
Boston Scientific's complaint investigations have identified that a subset of air ingress complaints are associated with hemostatic valve damage related to dilator insertion orientation during device preparation. Valve damage may result in air ingress, potential air embolism, and associated patient harm. This risk can be mitigated by inserting the dilator… — Boston Scientific Corporation · Class II · Ongoing · 74,760 units
Boston Scientific is replacing specific FARASTAR PFA generators which have a configuration that is not compatible for use with the FARAPOINT PFA catheter. — Boston Scientific Corporation · Class II · Ongoing · 6 units
Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. — AVID Medical, Inc. · Class II · Ongoing · 112 kits
Due to manufacturing issues, reperfusion catheters may fractures — Penumbra, Inc. · Class II · Ongoing · N/A
Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change. — Alphatec Spine, Inc. · Class II · Ongoing · 3
For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hype… — Medtronic MiniMed, Inc. · Class II · Ongoing · 3,465
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. — Boston Scientific Corporation · Class II · Ongoing · 18 units
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness. — Medline Industries, LP · Class I · Ongoing · 318 kits
ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE Fluid Warming Sets due to potentially inadequate solvent application at the tubing to return connector bond. — ICU Medical Inc. · Class II · Ongoing · 39,750 units
Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility. — Karl Storz Endoscopy · Class II · Ongoing · 45
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Labeling discrepancy: Devices distributed with Instructions For Use (IFU) did not include FARAPOINT PFA catheter information. — Boston Scientific Corporation · Class II · Ongoing · 1 units
Product may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case condition, rail mechanism may become lodged during operation and movement of the stretcher along the rail may no longer be possible through either powered or manual operation. May cause delays in transport of… — Ferno-Washington Inc · Class II · Ongoing · 278
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. — Medline Industries, LP · Class II · Ongoing · 398 kits
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful. — Medline Industries, LP · Class II · Ongoing · 980 kits
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species. — Medline Industries, LP · Class II · Ongoing · 1601 units