ADAPTABLE Beach Chair Beach Chair Surgical Patient Positioner
The Adaptable Beach Chair surgical patient positioner has a manufacturing issue with an inadequate weld for the head positioning system.
Medical device recalls
Medical device recalls from FDA, newest first.
1 recall
1 recall
Custom Interventional Pain Management Mastisol Skin Adhesive and Continuous Epidural Trays
Mastisol Skin Adhesive has manufacturing issues with the liquid adhesive in surgical trays.
1 recall
Penumbra System (RED 62 Reperfusion Catheter)
The Penumbra System (RED 62 Reperfusion Catheter) may fracture due to manufacturing issues.
1 recall
NOxBOXi Nitric Oxide Delivery System
The NOxBOXi Nitric Oxide Delivery System may have irregular oxygen readings due to a manufacturing issue.
1 recall
Hollister Onli Hydrophilic Urethral Intermittent Catheters
The Onli 17cm Hydrophilic Urethral Intermittent Catheter may have a protrusion that could cause genitourinary trauma or bleeding.
1 recall
Penumbra System RED 68 Reperfusion Catheter
The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.
1 recall
SeaSpine Polyaxial Head
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
2 recalls
Oscor Abiomed Impella Introducer Kits
The introducer kit for the Impella system may leak from the sidearm, under the sheath cap, and along hub score lines.
3 products
Abiomed Impella Heart Pumps and Introducer Kits
A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers.
13 products
1 recall
ConvaTec Aquacel Ag Surgical SP
Surgical dressing manufactured out of specification (greater thickness).
2 recalls
Bard Catheters, Dialysis Catheters, and Biopsy Trays
The lidocaine ampoules in these devices were manufactured under deficient practices and are being recalled by the supplier.
14 products
Medtronic Harmony Delivery Catheter System
The Medtronic Harmony Delivery Catheter System may have an increased potential for distal tip detachment under certain conditions.
1 recall
Octopus 4, Evolution, and Evolution AS Tissue Stabilizer
The Octopus Evolution Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.
3 products
1 recall
Acumed Hexalobe Screws
Acumed Hexalob Screws may break during use due to a manufacturing error.
1 recall
Smith & Nephew Trigen Proximal Straight Humeral Nail
The humeral nail is missing distal holes and may lead to revision surgery if implanted.
1 recall
Spacelabs Ultraview SL Command Module
The Spacelabs Ultraview SL Command Module has a manufacturing issue with its electrical leakage tester.
1 recall
Abbott I-STAT EG7+, EG6+, and G3+ Cartridges
I-STAT cartridges may report higher PCO2 and lower pH results, appearing as severe respiratory acidosis.
3 products
1 recall
SurgiSmoke Solutions Flamingo Funnel
Flamingo Funnels were made with a non-gamma sterilization compatible drape.
3 products
1 recall
Angiodynamics AccuVu and Soft-Vu Angiographic Catheter
A manufacturing defect may prevent the guidewire from passing through the catheter hub.
20 products
2 recalls
OrthAlign Lantern Knee System Drill Plates
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
2 products
Straumann Custom Abutments
A material mix-up had occurred during the manufacturing of Straumann¿ Custom Abutments.
2 products
1 recall
ConvaTec EsteemBody Drainable Pouches
Convatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.
3 products
1 recall
Insulet Omnipod 5 Pods
Omnipod 5 Pods may have a tear causing insulin to leak inside, leading to under-delivery or cessation of insulin.
1 recall
Medtronic Octopus Nuvo Tissue Stabilizer
The Octopus Nuvo Tissue Stabilizer has tubing incorrectly positioned, which may cause assembly issues.
