Class I - Dangerous
Pouches may not have been sealed during packing.
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Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Gold Slotted Screw Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Wire which deploys the loop may be come detached at the handle causing the device to be inoperable
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Masks in this lot, labelled and sold as 62702 vented Quattro Air FFM size Medium actually contain a non-vented (NV) Quattro Air FFM Large mask.
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier
Class I - Dangerous
Mindray has identified a potential leakage issue with the CO2 Module's Dryline II Water Trap used with the Passport Series Patient Monitor.
Potential for compromise of the package resulting in a breach of the sterile barrier
MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the Sum Multiple Ions feature.
Conical Abutment Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
PEDIATRIC KIDNEY BIOPSY TRAY
Avid Medical
Class I - Dangerous
Avid Medical Inc. states a latex-containing Telfa" Non-adherent Dressing 4"x3" (10.2cm x 7.6 em) was included in a limited number of convenience kits (custom procedure trays) that were not labeled as containing latex.
Preformance Post Dental implants
Biomet 3i
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Internal investigation found the certain lots of MRSA kits have the potential for performance issues at lower positive sample concentrations.
Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
Class I - Dangerous
Pouches may not have been sealed during packing.
Class I - Dangerous
Pouches may not have been sealed during packing.
Potential for compromise of the package resulting in a breach of the sterile barrier