Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,151–7,200 of 7,979
- Class II
Medical Device Recall · February 6, 2024
X3 TRIATHLON CS INSERT NO 6 10 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
X3 TRIATHLON CS INSERT NO 3 10 MMPotential packaging breaches of inner blister and outer sterile blister.
- Class II
Medical Device Recall · February 6, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cementedDue to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.
- Class II
Medical Device Recall · February 5, 2024
Retractable Technologies, Inc.
EasyPoint Needle, 25G x 5/8", REF: 82091The needle cannula of a retractable needle may detach from the needle holder in the patient.
- Class II
Medical Device Recall · February 5, 2024
Abbott Aveir Leadless Pacemaker, REF: LSP112V, STERILEEOTheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change.
- Class I
Medical Device Recall · February 2, 2024
CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS9090SD; c) GS9095SD; Vascular guide-catheter, single-useMedos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural delay, vascular injury and in extreme rare occasions it may result in embolism.
- Class II
Medical Device Recall · February 2, 2024
Beaver Visitec International, Inc.
BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye Catalog Number: 581012Pack and pouch label is missing the manufacturing and expiration date.
- Class III
Medical Device Recall · February 1, 2024
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Class III
Medical Device Recall · February 1, 2024
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumProducts that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Class II
Medical Device Recall · February 1, 2024
BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and potential data loss.
- Class III
Medical Device Recall · February 1, 2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.
- Class II
Medical Device Recall · January 31, 2024
Trumpet, Needle Guide, Cat# TMS-200The Ring on the Trump Needle Guide can detach when excessive pressure is applied.
- Class II
Medical Device Recall · January 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD used to calibrate the Microalbumin Assay Catalog Number: MA1567Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other methods and may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Class II
Medical Device Recall · January 31, 2024
Microalbumin Calibrator Series (mALB CAL)-IVD to calibrate the Microalbumin Assay Catalog Number: MA2426Microalbumin Calibrator Series, MA1567 & MA2426, is running with a negative bias compared to other method may misclassify patient results. Users may experience a shift in Quality Control and patient sample recovery of up to +12%.
- Class II
Medical Device Recall · January 30, 2024
Applied Medical Resources Corp
Epix Universal Clip Applier, REF: CA500, STERILEEOTheir is the potential that Universal Clip applier may not load clip after the trigger is actuated.
- Class II
Medical Device Recall · January 30, 2024
Applied Medical Resources Corp
Epix Universal Clip Applier, REF: CA500, STERILEEO included within the following kit Reference Numbers: GK1003, AME Kit 54562 GK1004, KIT LAP CHOL DEN HOED 2, GK1005, K2550 - H¿PATECTOMIE ERASME,Their is the potential that Universal Clip applier may not load clip after the trigger is actuated.
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STIFF .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-759Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 NI/TU NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-762Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 15 CM STIFF .018 NI/TU NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-776Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-775Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-758Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-774Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10 CM STD .018 NI/TU ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-750Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS ECHO 2.75" PG -Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-754Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 NI/TU ECHO 2.75" PG Catalog Number: 45-756Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10 CM STD .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-749Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/PD ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-752Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG- Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-765Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10 CM STIFF .018 SS/SS ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-751Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 4F X 10CM STIFF .018 NI/TU ECHO 1.6" PG- Used for the percutaneous introduction of a guidewire into the vascular system. - Catalog Number: 45-781Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 30, 2024
MINI STICK MAX 5F X 10 CM STD .018 SS/SS NON-ECHO 2.75" PG-Used for the percutaneous introduction of a guidewire into the vascular system. Catalog Number: 45-767Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through the introducer is due to the presence of voids in the internal lumen of the sheath hub, potential risk of the non-conformance is a delay in procedure, wherein the user may need to exchange the sheath to complete the case
- Class II
Medical Device Recall · January 29, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Wedged (25mm)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
- Class II
Medical Device Recall · January 29, 2024
Olympus Corporation of the Americas
SOLTIVE Pro SuperPulsed Laser (TFL-SLS )A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Class II
Medical Device Recall · January 29, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
Embrace Drill Tower, Standard/Lateral (25mm)The surgical techniques for the Embrace Shoulder Instruments -Drill Tower (Article REF 645-081/62 & /63) have mixed-up type descriptions ("standard" vs "wedged") in the overview of the instruments.
- Class II
Medical Device Recall · January 29, 2024
Olympus Corporation of the Americas
SOLTIVE Premium SuperPulsed Laser (TFL-PLS )A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Type E/F plug configurations.
- Class II
Medical Device Recall · January 29, 2024
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Shimadzu, Trinias, Digital Angiography SystemDue to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnormal display or no function.
- Class II
Medical Device Recall · January 29, 2024
Canon Medical System, USA, INC.
MRI system: Vantage Orian, Vantage Fortian, Model: MRT-1550For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Class II
Medical Device Recall · January 29, 2024
NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic reProduct is recalled due to reports of blood leaking or spraying from the arterial line on the cartridge.If this failure occurs, a patient may experience uncontrolled blood loss or a healthcare professional could be exposed to infectious patient blood.
- Class II
Medical Device Recall · January 29, 2024
Canon Medical System, USA, INC.
MRI system: Vantage Elan, Model: MRT-2020For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Class II
Medical Device Recall · January 29, 2024
Canon Medical System, USA, INC.
Vantage Titan, Model: MRT-1504For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety manual are lower than the correct values, which may cause a patient with an MR conditional device to feel some discomfort during the MR scan.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 7600 Integrated System, Catalog No. 6844461A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS XT 3400 Chemistry System, Catalog No. 6844458A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
I.B.S¿ 6.5-C Compression screw - diam 6.5mm lg 80mm,Part Number S65 ST180This Field Action is being conducted following the identification of a batch mix-up between I.B.S Compression screws diameter 6.5mm length 75mm and I.B.S Compression screws diameter 6.5mm length 80mm. The screws of the batches concerned by the recall may have different lengths from those issued on their labels.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 4600 Chemistry System Catalog Nos. 6802445 (regular) and 6900440 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.This IVD is colorless. A customer complaint was received noting it appeared pink. A review of inventory confirmed additional stock appeared pink.
- Class II
Medical Device Recall · January 26, 2024
IdentiTi ALIF Standalone Interbody System: Part Number/Description 132-10-85-250 / IdentiTi ALIF SA Graft Bolt, 08.5 x 25 mm 132-10-85-300 / IdentiTi ALIF SA Graft Bolt, 08.5 x 30 mm 132-10-85-350Due to reports of intraoperative graft bolt implantation breakages.
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 3600 Immunodiagnostic System Catalog Nos. 6802783 (regular) and 6802914 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.0 and 3.8.1 causes the Configurable Westgard Rules to not report as expected. When a new control is defined, configurable Westgard rules, if selected, are not flagged or reported with the applicable QC results if the statistical criteria is met. This may result in acceptance of QC results that do not meet acceptance criteria, which may cause erroneous patient results to be reported.
- Class II
Medical Device Recall · January 26, 2024
BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD BACTEC Peds Plus medium BD BACTEC Plus Aerobic medium BD BACTEC Plus Anaerobic medium BDue to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
- Class II
Medical Device Recall · January 26, 2024
Ortho-Clinical Diagnostics, Inc.
VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.