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VITEK 2 AST-N447 TEST KIT Product reference 424620

Biomerieux Inc

Jul 15, 2026Biomerieux Inc

VITEK 2 AST-N447 TEST KIT Product reference 424620

Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.

Food & Beverage

FDA Food

Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufactured by LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.

Fresh & Ready Foods LLC

FDA FoodClass I

Fresh to You Burger Chicken Fillet Deluxe with Bacon, SKU 10303, Net wt. 5.9oz. Product is refrigerated. UPC 1 00000 01030 3. Manufactured by LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Deluxe With Bacon sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

Jul 15, 2026Fresh & Ready Foods LLC

Pharmaceutical

FDA Drugs

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

QuVa Pharma, Inc.

FDA DrugsClass II

Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, Compounded drug, QuVa Pharma, 1075 W Park One Dr, Suite 100, Sugar Land, TX 77478, Product code: 70092-1310-46.

Failed Impurities/Degradation Specifications

Jul 15, 2026QuVa Pharma, Inc.

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Elekta, Inc.

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

Jul 15, 2026Elekta, Inc.

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

CMR SURGICAL LIMITED

Jul 15, 2026CMR SURGICAL LIMITED

Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US Model/Catalog Number: V-SS-1020 Software Version: Pratchett 1 version 62.1 Product Description: The Versius Surgical System is a modular, open console, software controlled, electromechanical system designed for surgeons to perform minimally invasive surgery.

Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

Integra LifeSciences Corp. (NeuroSciences)

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

Jul 15, 2026Integra LifeSciences Corp. (NeuroSciences)

OmniTract Surgical Retractor System, which includes 633 of the firm s product codes.

The current Omni-Tract Surgical Retractor System IFU states a dry time of 30 minutes. Integra LifeSciences has identified that the dry time needs to be extended to 90 minutes, 110 minutes, or 120 minutes depending on the sterilization cycle exposure time used.

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

WALLAC OY

Jul 15, 2026Fresh & Ready Foods LLC

GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.

Reduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting of patient results.

Jul 15, 2026WALLAC OY

Food & Beverage

FDA Food

Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufactured By LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.

Fresh & Ready Foods LLC

FDA FoodClass I

Fresh to You Burger Chicken Fillet, SKU 10150, Net wt. 5oz. Product is refrigerated. UPC 1 00000 01015 0. Manufactured By LPK1 Renton, WA. Product was not sold at retail stores and sold only to employees at certain business' breakroom.

Raw breaded chicken patties were inadvertently used in the ready to eat Burger Chicken Fillet sandwich. Raw breaded chicken patties pose a risk of foodborne illness due to the potential presence of Salmonella.

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Encore Medical, LP

Jul 15, 2026Encore Medical, LP

Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 341-14-711 Product Description: Enovis knee devices are for knee arthroplasty.

Due to packaging discrepancy with incorrect product size mixed up.

Food & Beverage

FDA Food

High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR, WHOLE MILK POWDER, SOY LECITHIN RAISINSCONTAINS MILK AND SOY Distributed by Lehi Valley Trading Company of Mesa, AZ.

Lehi Valley Trading Company, Inc

FDA FoodClass I

High Valley Orchard Chocolate Covered Raisins, net wt. 15oz. per package, each case contains 12/15oz. bags. Product is packaged in clear plastic container. UPC on retail container: 0 952348 80170 0. The label of affected product declares: INGREDIENTS: MILK CHOCOLATE (SUGAR, WHOLE MILK POWDER, SOY LECITHIN RAISINSCONTAINS MILK AND SOY Distributed by Lehi Valley Trading Company of Mesa, AZ.

Undeclared Peanut. High Valley Orchard Chocolate Covered Raisins contains unintended undeclared peanut due to mis-packaging.

Jul 15, 2026Lehi Valley Trading Company, Inc

Charlevoisienne and Joe Smoked Meat brand meat products recalled due to Listeria monocytogenes

CFIA

Health CanadaClass 1

Charlevoisienne and Joe Smoked Meat brand meat products recalled due to Listeria monocytogenes

Listeria

Jul 10, 2026CFIA

Australia

Key Sun Kids Cough Homeopathic Product Multipack Lozenges and Kids Cold Homeopathic Product Raspberry Lozenges

TGA

au-tgaMedical Device ...

Key Sun Kids Cough Homeopathic Product Multipack Lozenges and Kids Cold Homeopathic Product Raspberry Lozenges

Key Sun Laboratories Pty Ltd is recalling four batches of lozenges due to the risk of a small metal wire being present in the lozenge....

Jul 9, 2026TGA

The Butcher Barn brand meat products recalled due to undeclared mustard and soy

CFIA

Health CanadaClass 1

The Butcher Barn brand meat products recalled due to undeclared mustard and soy

Mustard - Soy

Jul 9, 2026CFIA

Health CanadaGeneral Alert

Insignia® Gas Ranges recalled due to fire hazard

Consumer product safety

Insignia® Gas Ranges recalled due to fire hazard

Fire hazard

Jul 9, 2026Consumer product safety

Health CanadaGeneral Alert

Cuisinart Propel+ Four Burner 3-In-1 Gas Grills recalled due to a laceration hazard

Consumer product safety

Cuisinart Propel+ Four Burner 3-In-1 Gas Grills recalled due to a laceration hazard

Laceration hazard

Jul 9, 2026Consumer product safety

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Jul 8, 2026Zimmer Surgical Inc

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC Connectors Model/Catalog Number: 60-1812-101-00 Software Version: N/A Product Description: Dual Sterile Extension Hose with PLC Connector Component: N/A

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find another readily available device.

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

Medela Inc

Brand Name: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD / 101033086 Software Version: N/A Product Description: Enteral Extension Set, Length 60 Orange-Striped Minibore Tubing, (Approx. Priming Vol. 2.00 mL), ENFit¿ Component: N/A

May contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in delivery of enteral nutritional fluids or oral medication.

Jul 8, 2026Medela Inc

Baxter Healthcare Corporation

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables

Jul 8, 2026Baxter Healthcare Corporation

Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in conjunction with the side rails of the Upper Back Section H V U component (product code 1909813) on Baxter operating tables

The Adapter for Head Positioning accessory may become loose during patient positioning and unintentionally move when used in conjunction with the side rails of the Upper Back Section H V U component on Baxter operating tables.

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A

TELEFLEX LLC

Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling¿ Wecksorb Neurosponge Strips (Cotton) Model/Catalog Number: 200100 200101 200102 200103 200104 200105 200106 200108 200110 200112 200120 200121 200123 200131 Software Version: N/A Product Description: Wecksorb Neurosponges are made of an absorbent cotton material. Certain Neurosponge varieties are available with an x-ray detectable thread to assist with location within the surgical site. Some Neurosponges (patties) have a string for accountability during the post-surgical verification process. Wecksorb Neurosponges are for use in the protection of tissue during surgical procedures; tissues include the brain and other central nervous system tissues. Neuro sponges are used during cranial and spine surgery to moisten the dura or to cushion against bone edges. They are also used to protect brain tissue under the dura or elsewhere during incision. Component: N/A

Due to out-of-specification, or potential out-of-specification, levels of endotoxins

Jul 8, 2026TELEFLEX LLC

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Zimmer Surgical Inc

Jul 8, 2026Zimmer Surgical Inc

Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC Connectors Model/Catalog Number: 60-4009-101-00 Software Version: N/A Product Description: Single Sterile Extension Hose with PLC Connector Component: N/A

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.

Covidien LLC

Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include the Covidien Shiley Disposable Decannulation Plug are: Product Number / UDI-DI code 4DCFN 10884522006576 4DCFS 10884522006583 4DFEN 10884522006606 6DCFN 10884522006613 6DCFS 10884522006620 6DFEN 10884522006644 8DCFN 10884522006651 8DCFS 40884522006690 8DFEN 10884522006675 10DCFN 20884522006535 10DCFS 10884522006545 10DFEN 10884522006569 The Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.

Due to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.

Jul 8, 2026Covidien LLC

Health CanadaGeneral Alert

Rowenta Cordless Vacuum Cleaners recalled due to fire and burn hazards

Consumer product safety

Rowenta Cordless Vacuum Cleaners recalled due to fire and burn hazards

Burn hazard - Fire hazard

Jul 8, 2026Consumer product safety

Laborie Medical Technologies Corp

Solar GI System (Water Perfusion); Product Name (Catalog Number): Solar GI LGI H2O, 12p, Trolley system (G3-6), Solar GI HRM H2O, 24p, Compact Pole system (G3-7), Solar GI HRM H2O, 24p, Trolley system (G3-8), Solar GI HRM H2O, 36p, Trolley system (G3-12), Solar GI HRAM H2O, 24p, Trolley system (G3-14);