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FDA DevicesOlympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological and gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DevicesMRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light
Due to battery component overheating while charging resulting in melting of internal components and causing smoke.
FDA DevicesOlympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
FDA DevicesOlympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Health CanadaElixir -40 C windshield washer fluid recalled due to improper labelling and lack of child-resistant packaging
Elixir -40 C windshield washer fluid recalled due to improper labelling and lack of child-resistant packaging
Labelling and packaging
Health CanadaTransport Canada Recall - 2025628 - FORD
Transport Canada Recall - 2025628 - FORD
High Voltage
Health CanadaAbiomed Purge Cassette Generation 1 for Impella
Abiomed Purge Cassette Generation 1 for Impella
Performance
Health CanadaMadsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Madsen® AccuScreen® TEOAE/DPOAE/ABR Probe
Performance
Travel Hairdryer XDM 3600
The hairdryer’s motor may overheat, causing the folding switch to fail and the plastic grill to ignite.
Fidget Spinner LED Light Up Pen
The toy doesn’t comply with the mandatory standards for products containing button/coin batteries . The battery isn’t secured, and children could access the button/coin battery. The product is missing warning information about: the dangers of button/coin batteries to children what to do when a person suspects someone has swallowed or placed a button/coin battery inside any part of their body
FDA DevicesMedline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Knee and Humeral socket implants contain incorrect labeling.
FDA DevicesBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Knee and Humeral socket implants contain incorrect labeling.
FDA FoodMung Beans packaged in 4lb polybags; 6-4lb bags per carton
Mung Beans packaged in 4lb polybags; 6-4lb bags per carton
Presence of Thiamethoxam-PESTICIDE
FDA DevicesOlympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DevicesOctopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
Octopus Nuvo Tissue Stabilizer, disposable tissue stabilization system, Product Number TSMICS1
During the manufacturing, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached to the top, contrary to the intended design.
FDA DevicesConvenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Convenience kits used for dialysis maintenance Medline ADD A CATH DIALYSIS KIT SKU ECVC8415A Centurion CENTRAL LINE INSERTION TRAY SKU DT19810 Centurion DIALYSIS BUNDLE WITH NO CATHETTER SKU CVI4310A Medline DIALYSIS CAP CHANGE KIT SKU DYNDC2425 Medline DIALYSIS CHANGE KIT SKU EBSI1453A Centurion HEMODIALYSIS ACCESS KIT SKU DT12970 Medline LARGE BORE, DIALYSIS, ENHANCED SECUREMENT SKU EBSI1741
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesOlympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
FDA DevicesOlympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
FDA FoodIQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305
IQF Blueberry (30lbs. cases and 1400 lbs. totes), product of USA. Product is packaged in polyethylene bag within a corrugated 30lbs. case or packaged in polyethylene liner within a Gaylord 1400lbs. tote. Product was not sold to consumers from retail stores. Willamette Valley Fruit Company 2994 82nd Ave. NE Salem OR 97305
Listeria monocytogenes
FDA DevicesPIE PAK Models: P2HC-A, P2HC-S, P2HC
PIE PAK Models: P2HC-A, P2HC-S, P2HC
Lack of 510K clearance
FDA FoodYO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
YO!MAN CUCUMBER (FRESH HUNAN FLAVOR); Ingredients: Cucumber, chili pepper, edible vegetable oil, salt, water, sugar, brewing vinegar, food additives (monosodium glutamate, sodium dehydroacetate, potassium sorbate, streptoccoccus lactis, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, xanthan gum), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 10 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529602
Product contains undeclared cyclamates.