Magellan Diagnostics LeadCare Blood Lead Test Kits
LeadCare blood lead test kits may show falsely elevated results when used with certain third-party micro-collection devices.
3 products
Medical device recalls
Medical device recalls from FDA, newest first.
5 recalls
2 recalls
Windstone Medical Packaging Custom Convenience Kits with Medline Namic Angiographic Control Syringes
Custom Convenience Kits contain syringes whose rotating adapter can unwind during use, risking loose connection or disconnection.
Siemens Artis Pheno Angiography Systems
ARTIS Pheno VE30A and VE40A may capture lighter and darker patient images, causing less accurate 3D reconstruction.
2 recalls
B. Braun Hemodialysis Bloodlines
B. Braun Hemodialysis Bloodlines may accumulate small air bubbles in the arterial line.
6 products
Clariance Elegance Anterior Cervical Plates
Elegance cervical plates have a burr on the finished product.
1 recall
Cook Instinct Plus Endoscopic Clipping Device
The Instinct Plus Endoscopic Clipping Device may malfunction due to increased complaints.
4 recalls
Remel Yeastone Broth
Yeastone Broth may report incorrect AST results during quality control, potentially causing delayed response or need to change antifungal agent.
LinkBio CORE Workstation
The LinkBio CORE Workstation may display an incorrect planning date on the start case menu screen.
Philips AneurysmFlow
Philips AneurysmFlow software may not provide reliable prognostic information about aneurysm occlusion after Flow Diverter Stent treatment.
Arjo Tenor Mobile Passive Patient Lift
The Arjo Tenor mobile passive patient lift has an internal actuator component that may not meet required mechanical strength.
1 recall
Stryker Sustainability Solution Color Cuff
The tourniquet cuffs can detach from the bladder at the welding connection.
1 recall
Brahms B.R.A.H.M.S PlGF Plus KRYPTOR Diagnostic Test
The B.R.A.H.M.S PlGF Plus Kryptor test may show out-of-range quality control values, potentially leading to falsely elevated sFlt-1/PlGF ratio results.
2 products
3 recalls
Medline Namic Angiographic Control Syringes and Medical Convenience Kits
NAMIC Angiographic Rotating Adaptor (RA) Control Syringes may unwind during use, causing a loose or full disconnection.
22 products
Siemens Artis Pheno and Artis Icono Biplane Systems
ARTIS pheno and ARTIS Icono biplane, floor and ceiling may sporadically display a major increase of the x-ray dose applied to the patient.
Spacelabs Healthcare Multi-Parameter Command Module
The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings and delayed care.
1 recall
Molded Products Luer Cap Sets
The See Luer Cap Set has a threaded sleeve that may not be engaged and can become unattached.
5 recalls
GE Healthcare SIGNA Premier Systems
SIGNA Premier systems, whole-body MR scanners, may have ferrous fittings that could attract and cause injury during service.
Medtronic MiniMed and Paradigm Insulin Pumps
Over-delivery can cause severe hypoglycemia, altered mental status, seizure, coma, or death.
14 products
Burlington Medical Radiation Protection Apparel
Burlington Medical BAT Coverage may degrade over time, decreasing its lifespan.
13 products
Oxoid Microbact Identification Kits Listeria 12L Kit
Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Philips Respironics Trilogy EV300, Evo, Evo O2, and Evo Universal
In some situations, the Obstruction Alarm does not trigger within the timeframe dictated by the relevant standards and may take up to four breaths.
4 products1 recall
Baxter Volara Ventilator Adapter Modules
The Blue Ventilator Adapter Module may cause unawareness of oxygen desaturation or barotrauma in home care.
1 recall
Abiomed Purge Cassettes and Impella Pump Sets
Purge Cassette has an increased risk of purge leaks.
2 recalls
Synthes 2.4 Volt Tap Locking and Cortex Screws
Bone taps have an incorrect thread due to a lot swap.
2 products
Olympus SOLTIVE Premium and Pro Laser Systems
The Soltive Pro and Premium laser systems may become inoperable and emit smoke or a burning smell.
2 products
10 recalls
Mentor Breast Tissue Expanders
Artoura Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.
7 products
Philips Allura Xper and Azurion Angiography Systems
Philips Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.
22 products
BD Kiestra ReadA
The BD Kiestra ReadA can have modules unreachable after a reboot, delaying plate retrieval.
Automated Impella Controller (AIC)
The Automated Impella Controller may delay its purge system blocked alarm when used with certain pumps.
Medline Enfit g-Tube Connector
The ENFIT G-TUBE CONNECTOR may not seal properly, leading to leakage that could cause delayed care and fluid loss.
2 products
Waldemar Link Embrace Drill Towers
The Embrace Drill Tower has mixed-up article numbers in the surgical technique overview.
2 products
Ultradent Jiffy Original Composite Polisher Cups
Jiffy Original Composite Polisher Cups may crumble and break apart easily, which could cause a delay in patient treatment.
Stryker CHROMOPHARE Softlit Ring Surgical Light System
The surgical light system may not adequately support the weight of the ceiling cover.
Philips Vue Motion V12
Vue Motion V12 may display image frames out of sequence during dynamic cine runs.
Atellica CH Enzymatic Hemoglobin A1c (A1c_E)
Atellica CH Enzymatic Hemoglobin A1c (A1c_E) may show depressed results when used with RCRP on the same analyzer, potentially delaying diabetes diagnosis.
2 recalls
Philips Respironics Trilogy Evo Ventilators
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
4 productsMerit Medical Hemodialysis Catheters and Sheath Introducer
Hemodialysis catheters and a sheath introducer may not split as intended.
5 products
2 recalls
Olympus Cutting Forceps
The cutting forceps have defective welds that can cause the jaw to break during use.
7 products
Tandem Pumps
Tandem pumps have a Czech user guide with translation errors that could lead to unintended insulin delivery and a hypoglycemic event.
1 recall
TECNIS Eyhance IOL with TECNIS Simplicity Delivery System
The TECNIS Eyhance IOL may have a haptic that sticks to the optic, preventing consistent unfolding.
1 recall
Handy Solutions Neck & Shoulders Heating Pad
The heating pad can cause burns to persons and property if folded or placed under the body.
4 recalls
I.T.S. Orthopedic Plates and Screws
Volar Radius Plate with Angular Stability may cause higher temperature increases under certain MRI conditions.
17 products
Olympus Endoscope Valves and Reprocessors
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
4 products
GE Medical Systems Imactis CT-Navigation Systems
There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position.
4 recalls
Datascope Battery Charging Station
The Battery Charging Station has a protruding screw that prevents proper charging of certain batteries.
Leksell Gamma Knife
The Leksell Gamma Knife has an adapter that may not be properly aligned or locked in place.
Aptima HPV Assay
The Aptima HPV Assay can generate invalid or false negative results.
STA Liatest D-Di
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
2 products
1 recall
Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment
The MICS3 Angled Sagittal Saw Attachment has screws that may loosen and detach during use.
