***Update** :HBsAg analyte is also Non-Reactive on the Ortho Vitros analyser as well as the Beckman Coulter DxI. Randox Serology I Positive Control will test negative (Non-Reactive) for Marker HBsAg resulting in delay in reporting patient results due to the positive control O36SR testing negative (Non-Reactive) for Marker HBsAg
All Recalls
95,102 total recalls in our database
AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1 Vivonic Part Number: G02000970-US
Fresenius Medical Care Holdings
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007
Associates of Cape Cod
Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes
Medtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by manufacturing error of specific turbine components.
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Maquet Medical Systems USA
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 Vivonic Part Number: G02000966-US
Fresenius Medical Care Holdings
Internal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Maquet Medical Systems USA
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Maquet Medical Systems USA
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM
GELITA MEDICAL GMBH
In routine bioburden testing, higher than acceptable levels of Endotoxins were observed.
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Maquet Medical Systems USA
The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
BD MaxGuard Extension Set, REF: ME1069
CAREFUSION
Administration set, and extension set product labels list expiration year 2027 but the labels should list expiration year 2025. If expired product is used, the integrity of the product may be compromised, and may result in potential leaks and risk of infection to the patient and healthcare worker.
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
Ceramic Mugs with Cork Bottoms
Unknown Manufacturer
The coffee cup can crack or break when hot liquid is poured into it, posing a burn hazard.
Ladders sold with Canyon Lake and Cottage Colors Bunk Bed and Hutch Sets
Montecitos Manufacturing, of Mexico
The space between the fourth ladder step and the cross-member of the hutch of the bunk bed is wider than 3.5 inches, posing entrapment and strangulation hazards.
Miffy First LED Lights
Unknown Manufacturer
The recalled lights can overheat during use, posing a burn hazard.
Pool and spa drain covers
Unknown Manufacturer
The recalled drain covers do not conform to the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing an entrapment hazard to swimmers and bathers.
Pool and spa drain covers
Unknown Manufacturer
The recalled drain covers do not conform to the entrapment protection standards of the Virginia Graeme Baker Pool and Spa Safety Act (VGBA), posing an entrapment hazard to swimmers and bathers.