🏥 Medical Devices Class I - Dangerous
Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
All Recalls
92,900 total recalls in our database
LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM
Smith & Nephew
🏥 Medical Devices Class I - Dangerous
The incorrect Loctite adhesive was used to assemble the impactor heads.
🏥 Medical Devices Class I - Dangerous
FANA200 kit lot TS 3577 was re-worked due to shortened shelf-life. The alert sticker on the kit box of the lot informed customers that the shelf-life had been shortened and referenced a letter sent to customers for more information, where the new expiration date was stated. The original kit box label remained on the kit box stating the original expiration date, the packaging did not display the correct expiration date.
SHIMADZU RADspeed Pro Catalog Number: RADspeed Pro; Stationary x-ray system
Shimadzu Medical Systems Usa Com
🏥 Medical Devices Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
da Vinci Xi(R) Surgical System Patient Side Carts (PSC) were shipped to the field with potentially under-torqued brake screws in a section of the system arms.
🏥 Medical Devices Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Individual vials of calibrator and standard were mislabeled; specifically the units on the vial labels are incorrectly listed as mg/dl when the correct unit is mg/L.
Access System-GI Monitor (CA19-9), A83873D, Catalog No. 387687
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
🏥 Medical Devices Class I - Dangerous
Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Mindray DS USA, Inc.
🏥 Medical Devices Class I - Dangerous
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
🏥 Medical Devices Class I - Dangerous
A customer experienced when using IMPAX CV Reporting software, specifically, when building a NIV report, the NIV Cardio report was showing incorrect findings for Aneurysm.
🏥 Medical Devices Class I - Dangerous
The courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
3M Company - Health Care Business
🏥 Medical Devices Class I - Dangerous
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
🏥 Medical Devices Class I - Dangerous
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.
🏥 Medical Devices Class I - Dangerous
Cracks may occur over time on the tube holding shaft near the base of the tube mounting flange.
🏥 Medical Devices Class I - Dangerous
The device collar size was incorrectly labeled as 25 mm where it should be recorded as 32 mm
Access Thyroglobulin, A34085G, Catalog No. 33860
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
Retention of Outdated Information in an Order Set. In the Care Plan Library, double clicking to add or delete a Component/Procedure to an Order Set does not trigger the update of the associated Care Plans.
Access Total T3, A34435H, Catalog No. 33830
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
The Access immunoassays are susceptible to biotin interference.
The Pointe Scientific CK-MB Isoenzyme Control Pointe Scientific CK-MB Level II Control, C7562-12 Control Kit
Medtest Holdings
🏥 Medical Devices Class I - Dangerous
Incorrect control range in product labeling