Medical Devices Recalls
Defective surgical instruments, diagnostic equipment, and health device recalls.
OER-ELITE Endoscope Reprocessor Connecting Tubes. Model/Catalog Number: MAJ-2116...
Potential for the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Soft-Vu Angiographic Catheter, Pigtail, Non-Braided; SOFT-VU PT 4F X 100CM 035 ...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
AccuVu Angiographic Catheter, Omni Flush, Non-Braided, With 21 R/O Markers; ACC...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
LeadCare¿ Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare¿ Plu...
Customers reported observing unexpectedly elevated results when using certain third-party micro-collection devices to collect capillary samples for testing with the LeadCare Test Systems. False positive lead results may cause delayed results and additional unnecessary testing.
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-05...
Potential for detachment of a distal tip component of the device during use.
Medline Kits: 1) PICC TRAY, Model Number: DYNJ41648A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543A
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
LSL Healthcare, IV Start Kit, Model/Catalog Number: 3131
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, RE...
The catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures for each stage.
AccuVu Angiographic Catheter, Pigtail, Non-Braided, With 21 R/O Markers; ACCU-V...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Medline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DY...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Avitene Ultrafoam Microfibrillar Collagen Hemostat - 8cm x 6.25cm x 1cm. Catalog...
Potential for product to contain foreign matter, confirmed to be inspect fragments.
Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Sy...
Unapproved design changes to the products outside of the 510(k) clearance.
Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71
X-Ray generator may malfunction resulting in the X-Ray being inoperable.
Flamingo Funnel Medium, Model Number SQ20012-02
Certain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Soft-Vu Angiographic Catheter, Sos Omni Selective (1), Non-Braided; SOFT-VU SO1...
The affected devices contain a manufacturing defect which may prevent the appropriately sized guidewire from passing through the inner diameter (ID) of the catheter hub.
Sequencing Agent SEQ0067, component of FoundationOne CDx (F1CDx)
Possible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants
LSL Healthcare, Central Line Dressing Kit, Model/Catalog Number: 2717H
Medical procedure kits were distributed containing Webcol Large Alcohol Prep Pads which were subsequently recalled for non-sterility.
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
MAC" Two-Lumen Central Venous Access Kit for use with 7.5 - 8 Fr. Catheters REF ...
Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured
Medline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Medline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO...
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.