Class I - Dangerous
The device may potentially cause a fire, leading to a safety risk.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
Kits contain leaking bottles of isopropyl alcohol
Kits contain leaking bottles of isopropyl alcohol
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150
MEDLINE INDUSTRIES, LP - SPT
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text, which could lead to selecting an incorrectly sized unit.
Class I - Dangerous
An incorrect Unique Device Identification (UDI) label was installed on some ZEISS Axio Observer 5 microscopes.
Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401
Intuitive Surgical
Class I - Dangerous
Due to the potential for unexpected motion caused by the partial disengagement of the instrument from the system.
Class I - Dangerous
Electrical component failure within the control unit. The observed failure mode is a loss of function of the device when used with handpiece and foot switch.
Class I - Dangerous
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0689093V, b. DYNJ62927
MEDLINE INDUSTRIES, LP - SPT
Class I - Dangerous
Kits contain leaking bottles of isopropyl alcohol
BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
Becton Dickinson & Company
Class I - Dangerous
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Aesculap Implant Systems
Class I - Dangerous
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Becton Dickinson & Company
Class I - Dangerous
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
Class I - Dangerous
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
Class I - Dangerous
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
Class I - Dangerous
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
CooperSurgical
Class I - Dangerous
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.
Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
Baxter Healthcare
Class I - Dangerous
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.
Class I - Dangerous
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of pressure ulcer development.