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Medical Device
FDA Devices
FDA DevicesInstinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Wilson-Cook Medical Inc.
FDA DevicesClass II
Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only, Sterile EO
Due to increased in complaints their is the potential for endoscopic clipping device to malfunction.
Apr 22, 2026Wilson-Cook Medical Inc.
RappelConsovolontaire (san...
farine des gourmets bleu - farine des gourmets bleu - 1 kg
taux d'alcaloïdes d'ergot supérieur à la valeur règlementaire
Apr 22, 2026farine des gourmets bleu
PharmaceuticalFDA Drugs
FDA DrugsSkin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA DrugsClass III
Skin Rehab, Calming Skin Gel, Hydrocortisone Balm, hydrocortisone 1%, .53oz net wt. (15.3g) per bottle, Distributed By: A.C.E. Inc., DFW Intl. Airport, Texas 75261, www.RHONDAALLISON.COM. NDC 66915-531-04
Subpotent Drug
Apr 22, 2026Island Kinetics, Inc. d.b.a. CoValence Laboratories
Food & BeverageFDA Food
FDA FoodLabel is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
PURE PALM C/O DVD
FDA FoodClass II
Label is predominantly green with white lettering in a clear plastic clamshell container. Pure Palm dates- Medjool Dates Net Wt. 16OZ UPC: 852160007005
mislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
Apr 22, 2026PURE PALM C/O DVD
RappelConsoGeneral Alert
moulin à grains broyeur portatif
le lubrifiant utilisé pour le moteur (huile minérale ou lubrifiante) peut entrer en contact direct avec le récipient de l'aliment. cela signifie que des traces de lubrifiant, qui ne doivent pas être ingérées, pourraient contaminer tout aliment préparé avec cet appareil. de plus, l'appareil ne dispose d'aucune protection efficace contre un desserrage accidentel de la borne de terre. si un relâchement se produisait, le système de mise à la terre ne fonctionnerait plus correctement. l'utilisateur pourrait donc recevoir un choc électrique.
Apr 22, 2026
PharmaceuticalFDA Drugs
FDA DrugsBupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Huons Co., Ltd.
FDA DrugsClass II
Bupivacaine Hydrochloride 0.75% in 8.25% Dextrose Injection, USP (15 mg/2 mL) (7.5 mg/mL) ampules, Rx only, Manufactured by: Houns Co., Ltd, 100, Bio valley, Je-cheor-Si, Chungcheongbuk-dc, Korea, NDC 73293-0002-1 (2 mL ampule), NDC 73293-0002-2 (50 x 2 Single-dose ampules); Distributed: Brookfield Pharmaceuticals, LLC, Brookfield, WI 53005, Made in S. Korea, NDC 71351-022-02 (ampule), NDC 71351-022-10 (10 count ampules), NDC 71351-022-50 (50 count ampules)
Lack of Assurance of Sterility
Apr 22, 2026Huons Co., Ltd.
PharmaceuticalFDA Drugs
FDA DrugsBlemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Island Kinetics, Inc. d.b.a. CoValence Laboratories
FDA DrugsClass II
Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.
Failed Stability Specifications
Apr 22, 2026Island Kinetics, Inc. d.b.a. CoValence Laboratories
PharmaceuticalFDA Drugs
FDA DrugsSLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Owen Biosciences Inc.
FDA DrugsClass II
SLMD Benzoyl Peroxide Acne Lotion, Benzoyl Peroxide 2.5%, a) 0.7 fl. oz - 21 mL and b) 1.5 fl. oz. - 44mL bottles, SANDRA LEE MD., Distributed by Skin PS Brands, Culver City, CA 90232.
Chemical contamination: Presence of benzene
Apr 22, 2026Owen Biosciences Inc.
Safety Alert
Health Canada
Health CanadaVariax 2 Locking Screw - Non-Sterile
Medical devices
Health CanadaType II
Variax 2 Locking Screw - Non-Sterile
Performance
Apr 22, 2026Medical devices
Safety AlertHealth Canada
Health CanadaAdapter For Head Positioning
Medical devices
Health CanadaType I
Adapter For Head Positioning
Performance
Apr 22, 2026Medical devices
Safety AlertHealth Canada
Health CanadaGino Bambino brand Gluten-Free Pizza Starter Kit recalled due to mould
CFIA
Health CanadaClass 3
Gino Bambino brand Gluten-Free Pizza Starter Kit recalled due to mould
Non harmful (quality or spoilage)
Apr 22, 2026CFIA
Safety AlertHealth Canada
Health CanadaMedline Neuro Sponges
Medical devices
Health CanadaType II
Medline Neuro Sponges
Sterility
Apr 22, 2026Medical devices
Safety AlertHealth Canada
Health CanadaALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia
Marketed health products
Health CanadaGeneral Alert
ALECENSARO (alectinib) and the Risk of Severe Hypertriglyceridemia
New safety information - Product safety - Adverse reaction
Apr 22, 2026Marketed health products
Medical DeviceFDA Devices
FDA DevicesBrand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Clariance-SAS
FDA DevicesClass II
Brand Name: Elegance¿ Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL PLATE, ELEGANCE 2 LEVEL CERVICAL PLATE, ELEGANCE 3 LEVEL CERVICAL PLATE, ELEGANCE 4 LEVEL CERVICAL PLATE Model/Catalog Number: See Excel sheet attached named "FDA 5072 Product Information" Software Version: Not applicable Product Description: The Elegance¿Anterior Cervical plate is designed for use as a cervical plate system. It has a shape which restores the intervertebral height and lordosis. The Elegance¿ Anterior Cervical plate consists in a variety of shapes and sizes of cervical plates with rounded corners, featuring bone screw s holes, locking systems and bone screws. The plates go from one (1) to five (5) levels, and the screws are selfdrilling or self- tapping, and fixed or variable. The fixation is provided by the bone screws inserted into the vertebral body by means of an anterior approach. The Elegance¿plates, as well as the bone screws, are made of compliant ASTM F136 Titanium alloy. It is essential to insert the implants with the instrumentation specifically designed for this purpose. For more description of the instrumentation, read the technical documentation associated to the Elegance¿ Anterior Cervical plate. Detailed information concerning the surgical technique of the Elegance¿Anterior Cervical plate is available upon request, please contact CLARIANCE or its local representative.
Due to a quality issue regarding the presence of burr on the finished cervical plate product.
Apr 22, 2026Clariance-SAS
Medical DeviceFDA Devices
FDA DevicesCytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Cytal Wound Matrix 2-Layer 7x10 cm. Product ID: WSM0710.
Increased rate of out-of-specification endotoxin results.
Apr 22, 2026Integra LifeSciences Corp. (NeuroSciences)
Medical DeviceFDA Devices
FDA DevicesBrand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
THERAKOS DEVELOPMENT LIMITED
FDA DevicesClass II
Brand Name: Cellex Photopheresis System Product Name: CELLEX Photopheresis Kit Model/Catalog Number: CLXUSA Software Version: Not Applicable Product Description: THERAKOS Photopheresis or extracorporeal photopheresis (ECP) is a photoimmune therapy where leukocytes are separated from whole blood via apheresis, combined with a photoactive drug (8-methoxypsoralen) and then exposed to ultraviolet A (UVA) light. All blood components, including the treated leukocytes, are returned to the patient. THERAKOS¿ Photopheresis utilizes the THERAKOS CELLEX System to combine cell separation and photoactivation into a single, closed and sterile circuit. The THERAKOS CELLEX Photopheresis System collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythrocytes to the patient. The buffy coat is passed through the photoactivation module where the drug is activated with a precise amount of UVA light determined by the characteristics of the individual patient s buffy coat. After photoactivation, the buffy coat is immediately returned to the patient s bloodstream. Component: Not Applicable
Increased difficulty in installing the centrifuge bowl onto the centrifuge bowl holder. Improper installation may cause the centrifuge bowl to dislodge, resulting in a broken bowl during the prime cycle or treatment phase, leading to a delay in patient treatment and blood loss.
Apr 22, 2026THERAKOS DEVELOPMENT LIMITED
Medical DeviceFDA Devices
FDA DevicesB Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
B Braun Medical Inc
FDA DevicesClass I
B Braun Hemodialysis Bloodlines, LOW VOL, NO CHAMBER 4.8MM PUMP SEGMENT. Model Number: B3-4630M4705.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Apr 22, 2026B Braun Medical Inc
PharmaceuticalFDA Drugs
FDA DrugsDiscount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
FDA DrugsClass II
Discount Drug Mart Food Market, Cough Drops, Menthol- Cough Suppressant Anesthetic, Honey Lemon, 30-count bag, Distributed By: Drug Mart-Food Fair, Medina, Ohio, 44256, Made in China, NDC: 83698-150-30, UPC: 093351037092.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Apr 22, 2026Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Medical DeviceFDA Devices
FDA DevicesB. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
B Braun Medical Inc
FDA DevicesClass I
B. Braun Hemodialysis Bloodlines, STREAMLINE BLOODLINE SET FOR DIALOG DR. Model Number: SL-2010M2096A.
Potential for the accumulation of small air bubbles in the arterial line due to adherence of blood gases to the tubing under negative pressure.
Apr 22, 2026B Braun Medical Inc
Medical DeviceFDA Devices
FDA DevicesCENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
Medline Industries, LP
FDA DevicesClass II
CENTURION Circumcision Kit, Medline Kit Number/SKU CIT7050F
On lot of Sterile Circumcision Kits was distributed without the required sterilization process and is therefore not sterile.
Apr 22, 2026Medline Industries, LP
Australia ProductsUtility task ve...
Mojo Motorcycles Off-Road LANDBOSS LH1100-D vehicle
The handbrake cable has been incorrectly routed which may result in handbrake malfunction, allowing the vehicle to roll away when parked.
Apr 22, 2026
Safety AlertHealth Canada
Health CanadaTransport Canada Recall - 1995112 - LAND ROVER
TC
Health CanadaGeneral Alert
Transport Canada Recall - 1995112 - LAND ROVER
Powertrain
Apr 22, 2026TC
Medical DeviceFDA Devices
FDA DevicesLinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
Linkbio Corp.
FDA DevicesClass II
LinkBio CORE Workstation, a component of the CORE Shoulder System. Product Code: 87-9136.
The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
Apr 22, 2026Linkbio Corp.
PharmaceuticalFDA Drugs
FDA Drugsexchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
FDA DrugsClass II
exchange select, Menthol- Cough Suppressant Oral Anesthetic, Cough Drops, Menthol Flavor, 30-count bag, Manufactured for Your Military Exchanges By: Medical Group Care, LLC, 1035 Collier Center Way, STE 5, Naples, FL, Made in China, NDC: 83698-581-30, UPC: 614299398887.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on product quality.
Apr 22, 2026Xiamen Kang Zhongyuan Biotechnology Co., Ltd.