Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DevicesCentricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
FDA DevicesBrand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Due to adapter not being properly aligned or locked in place.
FDA FoodMultivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
FDA DevicesConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA DevicesCentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
FDA DevicesBattery Charging Station; Model: 0998-00-0802;
Battery Charging Station; Model: 0998-00-0802;
The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue.
FDA DevicesBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
NHTSAVolvo Trucks North America - Instrument Panel Display Failure/FMVSS 101
Volvo Trucks North America - Instrument Panel Display Failure/FMVSS 101
An instrument panel display that fails to show critical safety information, such as the speedometer or warning lights, increases the risk of a crash.
FDA DevicesArtegraft Vascular Graft; REF#: AG740;
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
FDA DevicesMICS3 Angled Sagittal Saw Attachment; Part Number: 210490
MICS3 Angled Sagittal Saw Attachment; Part Number: 210490
A potential issue was identified with the torque strength on the external screws of the MICS3 Angled Sagittal Saw Attachment. These screws, which secure the cover to the Angled Saw Housing, may loosen during use and detach from the attachment.
FDA DevicesConvatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
FDA DrugsBrimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%*, 5 mL, Rx Only, Sterile, Apotex Corp. Manufactured for: Apotex Corp., Weston, FL 33326, NDC 60505-0589-1.
Lack of Assurance of Sterility
FDA FoodGREENWAY FARMS of Georgia GARLIC DILL PICKLES CHIPS Net Wt 16 fl oz (473 ml) UPC 8 57866 00501 0 Produced by: Greenway Farms of Georgia, LLC Roberta, GA Packed by Blue Frog Food, LLC for Green way Farms of Georgia, LLC 5875 Love St Austell, GA 30168
GREENWAY FARMS of Georgia GARLIC DILL PICKLES CHIPS Net Wt 16 fl oz (473 ml) UPC 8 57866 00501 0 Produced by: Greenway Farms of Georgia, LLC Roberta, GA Packed by Blue Frog Food, LLC for Green way Farms of Georgia, LLC 5875 Love St Austell, GA 30168
No process authority
FDA FoodGREENWAY FARMS of Georgia JALAPENO DILL PICKLES CHIPS Net Wt 16 fl oz (473 ml) UPC 8 57866 00506 5 Produced by: Greenway Farms of Georgia, LLC Roberta, GA Packed by Blue Frog Food, LLC for Green way Farms of Georgia, LLC 5875 Love St Austell, GA 30168
GREENWAY FARMS of Georgia JALAPENO DILL PICKLES CHIPS Net Wt 16 fl oz (473 ml) UPC 8 57866 00506 5 Produced by: Greenway Farms of Georgia, LLC Roberta, GA Packed by Blue Frog Food, LLC for Green way Farms of Georgia, LLC 5875 Love St Austell, GA 30168
No process authority
FDA FoodWawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated
Wawa Chocolate Low-fat Milk 16 oz , (Pint) Plastic bottle .Store Refrigerated
Foreign plastic material discovered on fill line.
FDA FoodWawa Reduced Fat Milk 2% 16 oz (Pint)
Wawa Reduced Fat Milk 2% 16 oz (Pint)
Foreign plastic material discovered on fill line.
NHTSAVolvo Trucks North America - Delayed Brake Release/FMVSS 121
Volvo Trucks North America - Delayed Brake Release/FMVSS 121
A delayed brake release can increase the risk of crash.
NHTSAAston Martin The Americas - TPMS May Not Illuminate for Low Pressure/FMVSS 138
Aston Martin The Americas - TPMS May Not Illuminate for Low Pressure/FMVSS 138
Underinflated tires increase the risk of a crash.
FDA DrugsChildren's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Children's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532, Made in India, NDC 51672-5321-8.
Presence of foreign substance: the firm received complaints for a gel-like mass and black particles in the product.
NHTSAVolkswagen Group of America, Inc. - Instrument Panel Failure/FMVSS 101
Volkswagen Group of America, Inc. - Instrument Panel Failure/FMVSS 101
An instrument panel that does not display critical safety information, such as the speedometer or warning lights, can increase the risk of a crash.
Germany BVL8 Kräuter, tiefgefroren, 75 Gramm der Marke "All Seasons"
8 Kräuter, tiefgefroren, 75 Gramm der Marke "All Seasons"
Krankheitserreger
Germany BVLGovinda Bio-Moringa-Kapseln 45 Gramm und 100 Gramm
Govinda Bio-Moringa-Kapseln 45 Gramm und 100 Gramm
Krankheitserreger
RappelConsosalma - bq 14 sau emmental 140g halal
salma - bq 14 sau emmental 140g halal
détection salmonelle spp
RappelConsoprix mini - epaule découenné dégraissé qualité choix prix mini 8tranches 360 g
prix mini - epaule découenné dégraissé qualité choix prix mini 8tranches 360 g
non conformite microbiologique