Recalls in California (page 29)
4209 recalls.
- Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog... recall (Davol, Inc.)
Medical deviceClass IIReported April 29, 2026 · Potential for product to contain foreign matter, confirmed to be inspect fragments. - LeadCare Ultra Blood Lead Test Kit recall (Magellan Diagnostics, Inc.)
Medical deviceClass IIReported April 29, 2026 · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing... - LeadCare¿ Plus Blood Lead Test Kit recall (Magellan Diagnostics, Inc.)
Medical deviceClass IIReported April 29, 2026 · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing... - (1)(2) LeadCare¿ II Blood Lead Test Kit, (3)LeadCare¿ II 5X Blood Lead Test Kit, recall (Magellan Diagnostics, Inc.)
Medical deviceClass IIReported April 29, 2026 · Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing... - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes... recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · Unapproved design changes to the products outside of the 510(k) clearance. - AccuVu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - AccuVu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - AccuVu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - AccuVu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft -Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Soft-Vu Angiographic Catheter recall (Angiodynamics, Inc.)
Medical deviceClass IIReported April 29, 2026 · The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the... - Medline Kits: 1) ARTHROSCOPY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) D AND C PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) HYSTEROSCOPY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) GYN LAPAROSCOPY PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) LABOR PACK-22025208-LF recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) ARTHROGRAM TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) SYR CONTROL 8ML ROTATING recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) NEWBORN ADMISSION recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) BREAST PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) GENERAL LAPAROSCOPY recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) ENT PACK recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) HEART TRANSPLANT BIOPSY recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) PICC TRAY recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) CATH LAB CDS recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) ANGIOGRAPHY PACK-LF recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT recall (Medline Industries, LP)
Medical deviceClass IIReported April 29, 2026 · The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. - CUSA Clarity C7000 Console recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 29, 2026 · Software issue that renders the touch screen unresponsive. - KMUYSL Big Red Barn Farm Animal Playsets Recalled Due to Risk of Serious Injury or Death from Choking; Violates Small Parts Ban; Sold on Amazon by MISSJUNE
Consumer productReported April 24, 2026 · The recalled children's toys violate the small parts ban because the toy is intended for children under three years of age and the fence handles can detach... - Cpzzkq Baby Loungers Recalled Due to Risk of Serious Injury or Death from Suffocation Hazard; Violates Mandatory Standard for Infant Support Cushions; Sold on Amazon by CetoPMax
Consumer productReported April 24, 2026 · The recalled baby loungers violate the mandatory safety standard for infant support cushions because the padding can obstruct an infant's breathing, posing a... - HappyGira Recalls Sweetie Baby and Style Life Eleven Baby Loungers Due to Risk of Serious Injury or Death from Suffocation and Fall Hazards; Violates Mandatory Standard for Infant Sleep Products
Consumer productReported April 24, 2026 · The baby loungers violate the mandatory standard for infant sleep products because the sides are shorter than the minimum side height limit to secure the... - Magnetic Stick Figure Sets Recalled Due to Risk of Serious Injury or Death from Magnet Ingestion; Violate Mandatory Standard for Toys; Sold on Walmart by BlissfulDestiny
Consumer productReported April 24, 2026 · The magnetic stick figures violate the mandatory standard for toys because they contain loose magnets posing an ingestion hazard to children. When high-powered... - 32 Degrees Recalls Heated Socks Due to Burn Hazard
Consumer productReported April 24, 2026 · When worn during high-intensity activities that generate a combination of heat, excessive friction, moisture and pressure, the socks can pose an injury hazard... - Autobrush Recalls Sonic Pro Children's Toothbrush Boxes Due to Risk of Serious Injury or Death from Battery Ingestion; Violates Mandatory Standard for Consumer Products with Coin Batteries
Consumer productReported April 24, 2026 · The recalled delivery boxes violate the mandatory standard for consumer products containing button cell and coin batteries because they contain a lithium coin... - Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by AMZCMJ DGD
Consumer productReported April 24, 2026 · The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious... - Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by TOETOL HOME
Consumer productReported April 24, 2026 · The recalled tower stools can collapse or tip over while in use and a child's torso can fit through the openings on the tower's sides, posing a risk of serious... - Tzumi Electronics Recalls FitRx SmartBell Quick-Select Adjustable Dumbbells Due to Serious Injury from Impact Hazard
Consumer productReported April 24, 2026 · Weight plates can dislodge from the handle during use, posing a risk of serious injury due to impact hazard. - Wiifo Children's Tower Stools Recalled Due to Risk of Serious Injury and Death from Entrapment and Fall Hazards; Imported by Wiifo
Consumer productReported April 24, 2026 · The recalled tower stools can collapse or tip over while in use, and a child's torso can fit through the openings on the tower's sides, posing a risk of... - mGanna Sodium Hydroxide Pellet Bags Recalled Due to Risk of Serious Injury or Death from Chemical Burns and Irritation to the Skin and Eyes; Violate Mandatory Standard for Child-Resistant Packaging; Sold on Amazon by Archie Xpress
Consumer productReported April 24, 2026 · The recalled products contain sodium hydroxide (lye), which must be in child-resistant packaging as required by the Poison Prevention Packaging Act (PPPA). The... - Gentuity HF-OCT Imaging System Model G10-01 recall (Gentuity, LLC)
Medical deviceClass IIReported April 22, 2026 · The potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx and Vis-Rx... - Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL... recall (Clariance-SAS)
Medical deviceClass IIReported April 22, 2026 · Due to a quality issue regarding the presence of burr on the finished cervical plate product. - Cytal Burn Matrix 10x15 cm. Product ID: BMM1015. recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 22, 2026 · Increased rate of out-of-specification endotoxin results. - Cytal Burn Matrix 7x10 cm. Product ID: BMM0710. recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 22, 2026 · Increased rate of out-of-specification endotoxin results. - Cytal Wound Matrix 2-Layer 10x15 cm. Product ID: WSM1015. recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 22, 2026 · Increased rate of out-of-specification endotoxin results. - Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710. recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 22, 2026 · Increased rate of out-of-specification endotoxin results. - Cytal Wound Matrix 2-Layer 5x5 cm. Product ID: WSM0505. recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIReported April 22, 2026 · Increased rate of out-of-specification endotoxin results. - Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only recall (Wilson-Cook Medical Inc.)
Medical deviceClass IIReported April 22, 2026 · Due to increased in complaints their is the potential for endoscopic clipping device to malfunction. - Lidocaine HCl Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Lidocaine HCl injection recall (Huons Co., Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Desmopressin Nasal Spray recall (Apotex Corp.)
DrugClass IIReported April 22, 2026 · Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners. - Magnesium Chloride recall (Avantor Performance Materials LLC)
DrugClass IIIReported April 22, 2026 · Subpotent drug - Blemish Spot Treatment recall (Island Kinetics, Inc. d.b.a. CoValence Laboratories)
DrugClass IIReported April 22, 2026 · Failed Stability Specifications - Memantine Hydrochloride Extended-Release recall (The Harvard Drug Group LLC)
DrugClass IIReported April 22, 2026 · Failed Dissolution Specifications - EPINEPHRINE Injection recall (International Medication Systems Ltd.)
DrugClass IIReported April 22, 2026 · Lack of Assurance of Sterility - Essential Calming Skin Gel recall (Island Kinetics, Inc. d.b.a. CoValence Laboratories)
DrugClass IIIReported April 22, 2026 · Subpotent Drug - Skin Rehab recall (Island Kinetics, Inc. d.b.a. CoValence Laboratories)
DrugClass IIIReported April 22, 2026 · Subpotent Drug - Remedy Gel recall (Island Kinetics, Inc. d.b.a. CoValence Laboratories)
DrugClass IIIReported April 22, 2026 · Subpotent Drug - Albuterol Sulfate Inhalation Solution recall (Nephron SC, LLC)
DrugClass IIReported April 22, 2026 · Labelling: Illegible label - Fluocinonide recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported April 22, 2026 · Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - Fluocinonide recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported April 22, 2026 · Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - Fluocinonide recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIReported April 22, 2026 · Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing. - QC Quality Choice recall (Xiamen Kang Zhongyuan Biotechnology Co., Ltd.)
DrugClass IIReported April 22, 2026 · This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing...