Agency
The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.
Sagent Pharmaceuticals is recalling two lots of Busulfan Injection due to failed impurities and degradation specifications. The affected lots were distributed nationwide.
Golden State Medical Supply Inc. is recalling Primidone 250 mg tablets due to cross-contamination with trace amounts of Acemetacin API. The affected lots are distributed nationwide.
Amerisource Health Services LLC is recalling Primidone Tablets 50 mg due to cross-contamination of the active ingredient with trace amounts of Acemetacin API. The recall affects 225,000 tablets distributed nationwide.
Amerisource Health Services LLC is recalling Primidone 250 mg tablets (Lot 1027583, expiration 09/30/2027) due to cross-contamination with trace amounts of Acemetacin API during manufacturing.
Medline Industries is recalling medical convenience kits containing Namic Manifolds due to particulate matter found in the fluid path. The recall affects three kit models distributed nationwide and internationally.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product packaging, which could compromise sterility and patient safety.
Medline Industries is recalling Namic Angiographic Manifolds because particulate has been found in the fluid path of the devices. The affected units were distributed nationwide in the U.S. and internationally.
Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product, which may compromise sterility.
Medline Industries is recalling the Namic Angiographic Manifold (Product Number 64038402) because particulate matter has been found in the fluid path. This medical device is used in cardiopulmonary bypass procedures.
MICROVENTION INC. is recalling LVIS Intraluminal Support Devices due to dimensional nonconformance and incorrect device configuration that may result from manufacturing commingling, creating risk of vessel injury, thrombosis, or neurological events.
Medline Industries is recalling cardiac medical convenience kits containing Namic Manifolds due to the presence of particulate matter within the fluid path. The affected kits were distributed nationwide and internationally.
Pure Ground Ingredients-Organic Peppermint Leaf Powder is being recalled because the product has the potential to be contaminated with Salmonella. The recall affects wholesale bulk product distributed to California.
Medline Industries is recalling approximately 7,075 units of the Namic Angiographic Manifold (SKU 64038200) due to particulate found in the fluid path. The manifold is used in cardiopulmonary bypass procedures and is distributed across the US and internationally.
Arrow International is recalling Cannon II Plus Hemodialysis Catheters due to a defective sheath introducer that may not split properly, potentially causing withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, and tissue injury.
Medline Industries is recalling medical convenience kits (HEART CATH PACK-LF, Kit Number DYNJ36478B) due to particulate matter found in the fluid path of the Namic Manifold. Affected kits were distributed in the US and internationally.
Medline Industries is recalling multiple cardiac catheterization kits because particulate contamination has been found within the fluid path of the manifolds used in these kits.
Medline is recalling 107 medical convenience kits containing Namic Manifold (TAVI) due to particulate found in the fluid path. The kits were distributed nationwide and internationally.
Windstone Medical Packaging is recalling Custom Convenience Kits containing Medline Namic Angiographic Control Syringes due to risk that the rotating adapter may unwind during use, potentially causing disconnection and exposure to biohazards, blood loss, infection, or air embolism.
Stryker Sustainability Solutions is recalling 107 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility assurance.
Arrow International is recalling Arrow-Clark VectorFlow hemodialysis catheters due to a supplier defect in the sheath introducer that may fail to split properly, potentially causing withdrawal resistance, prolonged procedures, pain, bleeding, and tissue injury.
Kroger Homestyle Cheese and Garlic Croutons are being recalled due to possible Salmonella contamination in the non-fat milk powder used to manufacture the product. The supplier of the milk powder issued a recall, prompting this product recall.
Medline Industries is recalling multiple cardiac catheterization kits due to the presence of particulate matter in the fluid path of manifolds. The affected kits were distributed nationwide and internationally.
Omnicell is recalling rolls of label stock used in the i.v.Station automation device due to potential for mislabeled syringes during IV medication preparation and compounding.
Hologic has recalled Selenia Dimensions Mammography Systems because internal bolts may become loose, missing, or broken over time. The company has received complaints of this issue affecting systems nationwide.
Oasis Medical, Inc. is recalling Oasis Tears PF preservative-free lubricant eye drops nationwide due to lack of assurance of sterility following FDA observations during an inspection.