Recall and safety-notice records

Records aggregated from the official sources MedWatcher monitors. Each record links back to its source with the agency identifier and dates. Sample records are labeled.

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Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

FDA · FDA event 99692Posted Oct 6, 2026

Class II recallOngoing

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The unverified/failed pumps released to users…

FDA · FDA event 99818

Recall and safety-notice records

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Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

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Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M recall — FDA event 99692

Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Descr recall — FDA event 99818

Brand Name: Tandem t:slim mobile application Product Name: t:slim Mobile Application, iOS Model/Catalog Number: iOS soft recall — FDA event 99589

INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP, Complete Set. Stay-Flex tubing component. 5 units per box. Model Nu recall — FDA event 99643

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

BMC/REACTHEALTH Luna G3 APAP REF LG 3600 recall — FDA event 99445

MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712; recall — FDA event 99374

Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge Item Number 15-0027/16 recall — FDA event 99405