Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
Brand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: E...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corre...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
I.T.S. Straight Plate with Angular Stability with the below descriptions and cor...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT)...
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419...
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Philips S4-1 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Brand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting For...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.6...
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
Brand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutt...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component La...
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
BioFlo DuraMax Catheter, REF: H965103028011/A, H965103028021/A, H965103028021/EU...
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Philips X7-2 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Brand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product N...
Olympus identified that the Cutting Forceps contain components for which the supplier did not adequately validate the welding process. Defective welds can result in the Cutting Forceps' jaw breaking during clinical use.
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20...
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Philips OMNI III TEE Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Philips C9-4 Ultrasound Transducer
To provide clarification and labelling to define the useful life of ultrasound transducers in the field.
Pilonplate with Angular Stability, with the below descriptions and corresponding...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Olecranonplate with Angular Stability with the below descriptions and correspond...
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,...
Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result.
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.
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
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.
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.