Medical Device Recalls
RSS ↗7,979 medical device recalls from federal enforcement feeds.
Showing 7,451–7,500 of 7,979
- Class II
Medical Device Recall · December 21, 2023
Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250RMedical devices distributed, prior to sterilization
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE BOTTLE KIT, Reorder Number DYNDH1738AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
Surgilon Braided Nylon sutures: 88861919-31 SURGILON* 4-0 BLK 7X75CMPCT 88861919-41 SURGILON* 3-0 BLK 7X75CMPCT 88861919-51 SURGILON* 2-0 BLK 7X75CMPCT 88861919-71 SURGILON* 1 BLK 7X75CM PCTSpecific lots of sutures were sterilized with gamma doses that exceeded the range approved. The extra gamma levels may decrease the strength of the sutures over time, which could result in harms such as wound dehiscence and hemorrhage/blood loss/ bleeding at a critical level.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1723Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE KIT, Reorder Number DYNDH1622CMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
Rebstock Holding rod for fixation -For holding and fixation of flexible Leyla Arms and spatula Art. No. 06-06-285 and 06-06-285MOD. surgical instrument.Holding arm could move (twist) uncontrollably in the front area. This could lead to a serious deterioration of patient's safety if the movement is transferred to the spatula, which is attached to the holding arm.
- Class II
Medical Device Recall · December 21, 2023
Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Suction Canister Liner Kit with 6 mm 1.8 m Tube, REF 65651-517The above-listed lots of Cardinal Health Medi-Vac CRD" Suction Canister Liners 1L may experience loss of suction on low or low intermittent suction settings, due to a misalignment of the liner with the outer hard canister.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE ADULT BLOOD CULTURE KIT, Reorder Number DYNDH1694AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 21, 2023
FLEXSelect 5/16" Amber Latex Elastics-Intended use is orthodontics, braces, tooth gap, Ref: AMD56Latex elastic bands were labeled as non-latex elastic bands, an allergic rx can occur due to patient latex allergy
- Class II
Medical Device Recall · December 21, 2023
Article No. NA6050411, Valiant PhD No. 1 EconoAffected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
- Class II
Medical Device Recall · December 21, 2023
MEDLINE INDUSTRIES, LP - Northfield
MEDLINE BLOOD CULTURE TRAY ADULT, Reorder Number DYNDH1194AMedline Industries, LP is issuing a recall for specific item(s) and lot(s) of Various Adult Blood and Blood Culture Kits. This recall is due to kits built using a Bactec component lot and expiration date that were not reflected on the kit insert. There is a risk of using an expired component if the user does not check the Bactec inside the kit for its expiration date.
- Class II
Medical Device Recall · December 20, 2023
Bard Nasogastric Sump Tube with ENFit, 10Fr., 36in Long, REF EN0042100BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Suction Connector with ENFit, REF EN0066000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 18Fr., 48in Long, REF EN0056180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
global Medium, Model Numbers LGGG-020 (20mL bottle), LGGG-050 (50mL bottle), LGGG-100 (100mL bottle). Intended use: Culture of human embryos from zygote to blastocyst, embryo transfer.The firm has become aware of a sudden increase in complaints for three associated lots. Performance issues may lead to impaired embryo development prior to the blastocyst stage.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 16Fr., 48in Long, REF EN0046160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Lopez Valve¿ with ENFit, REF EN0056000BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Anti-Reflux Filter and Lopez Valve¿ with ENFit, 12Fr., 48in Long, REF EN0056120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 16Fr., 48in Long , REF EN0056160BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 14Fr., 48in Long, REF EN0042140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 18Fr., 48in Long, REF EN0046180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube and PreVent¿ Filter and Lopez Valve¿ with ENFit, 14Fr., 48in Long, REF EN0056140BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit", 12Fr., 48in Long, REF EN0046120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 18Fr., 48in Long, REF EN0042180BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
MEDLINE INDUSTRIES, LP - Northfield
These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMIThere is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with ENFit, 12Fr., 48in Long, REF EN0042120BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 10Fr., 36in Long, REF EN0046100BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.
- Class II
Medical Device Recall · December 20, 2023
Barco MDSC-8527 NXF, Part Number K9352421Barco became aware of a problem with I2C cables in the manufacturing process of a limited batch of MDSC-85xx NXF products. The functionality of the built-in MNA decoder is blocked.
- Class II
Medical Device Recall · December 20, 2023
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or oWhen utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
- Class II
Medical Device Recall · December 19, 2023
Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78,Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- Class II
Medical Device Recall · December 19, 2023
Smiths Medical Medfusion Guide Barrel Clamp, Item number G6000716Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- Class II
Medical Device Recall · December 19, 2023
Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S Acu-Loc VDU Plate Standard, Left; 70-0046 Acu-Loc VDU Plate StandarDistribution without Pre-Market Clearance
- Class II
Medical Device Recall · December 19, 2023
Accessory Sets Syringes: 6ml syringe with a female luer with 15cm sealed SCD tubing, REF: RF-T15, and 60ml syringe on a female luer with 15cm sealed SCD tubing, REF: 15-RF60-TAccessory sets contain a syringes not yet qualified for the accessory's intended purpose; due to design changes to the syringe barrels and a polypropylene resin change that resulted in loss of gamma compatibility, for accessory set syringes that were gamma sterilized, which resulted in yellowed syringes.
- Class II
Medical Device Recall · December 19, 2023
Smiths Medical Model 3010 Syringe pumps: a. Protege Model 3010, b. Medfusion Model 3010A, c. Protege UK Model 3010EMedfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- Class II
Medical Device Recall · December 19, 2023
iQ Waste Well Adapter, Part Number: 700-3393Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
- Class II
Medical Device Recall · December 19, 2023
REV 2 Flowcell Capsule Spare, Part Number: C04154Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
- Class II
Medical Device Recall · December 19, 2023
Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500Medfusion Model 4000, 3500, and 3010 pumps manufactured or serviced with Barrel Clamp Guide (Part Number G6000716), Lot Numbers P0407365, P0486670, and P0561740 may contain a molding defect that could potentially lead to slippage of the spring within the barrel clamp assembly. If this occurs, it could result in the inability of the pump to recognize a syringe or the pump may misidentify the size of the syringe loaded.
- Class II
Medical Device Recall · December 19, 2023
EndoVive Replacement Button Kit w/ ENFIT 28F 2.8 CM, Outer Box UPN M00509500 or M00509510.Affected batches of the kit contain Stoma Measuring Devices sized to measure for an 18/24F replacement button, but are labeled as being for a 28F. Use of defective product may lead to undersizing the button, which may cause embedding with erosion into the gastric wall, tissue necrosis, infection, sepsis, and associate sequelae.
- Class I
Medical Device Recall · December 19, 2023
smiths medical Medfusion Model 3500 Syringe pumpMedfusion syringe pumps, with software versions before v6.0.0, may have the following issues:1. Delivery During Motor Not Running High Priority Alarm, 2. Infusion Restarted with Incorrect Parameters, 3. Screen Lock, 4. Interruption of Bolus or Loading Dose Delivery, 5. Pump Displays Incorrect Bolus/Loading Dose, 6. Loading/Bolus Dose Below the Minimum Recommended Rate, 7. Motor Rate Error, 8. Incorrect Recall Last Settings, 9. Corrupt Configuration, 10. Auto Lock, 11. Toolbox Configuration Loading Dose Time Values. Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software (v6.0.0) installed on your pumps.
- Class II
Medical Device Recall · December 19, 2023
Model A710 Intellis Clinician Programmer Application, version 2.0.97Medtronic has discovered an instance in which the Intellis A710 Clinician Programmer Application (CP App) could no longer establish a session with the Implantable Neurostimulator (INS) which resulted in the inability for the clinician to adjust stimulation parameters. In the event of this issue, the patient may receive inadequate or excessive therapy and experience non-optimal pain relief.
- Class II
Medical Device Recall · December 19, 2023
Beckman Coulter DxU 850m/840m Microscopy Analyzers, Part Numbers: C49513, C76947Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
- Class I
Medical Device Recall · December 19, 2023
smiths medical Medfusion Model 4000 syringe pumpMedfusion Model 4000 syringe infusion pumps, with the following software versions, may have the following issues: 1. Delivery During Motor Not Running High Priority Alarm (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 2. Re-administered Loading Dose (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 3. Incorrect Critical Data Failure Alarm, 4. Interruption of Bolus or Loading Dose Delivery (v1.0.0, v1.1.0, v1.1.1, v1.1.2), 5. Incorrect Total Bolus/Loading Dose Displayed (v1.1.0, v1.1.1, v1.1.2), 6. Volume Limit Before Bolus/Loading Dose Complete (v1.1.2), 7. Drug Library Lower Limit Displayed Incorrectly (v1.6.0, v1.6.1), 8. Depleted Battery Alarm (All versions previous to v1.6.5), 9. Loss of Wireless Connectivity (v1.5.0, v1.5.1, v1.6.0, v1.6.1, v1.6.4), 10. PharmGuard Server Password (v2.3, v2.4, v2.5). Smiths Medical corrected all issues included in this notification in previous software updates and the corrections were carried forward into all subsequent software releases. Please ensure you have the most recent Medfusion software installed on your pumps.
- Class II
Medical Device Recall · December 19, 2023
iQ200 Series Urine Microscopy Analyzers, Part Numbers: a) 700-3320, b) 700-3370, c) 700-3345, d) 700-3347, e) C10683, f) 700-3375, g) 700-3325, h) C10684Beckman Coulter has become aware that the cannula, which is found in the Flowcell and the iQClear Rinse Waste Well Assembly, may rust. Rust from the cannula has the potential to generate erroneous results.
- Class I
Medical Device Recall · December 18, 2023
regard Operative LAP, Item Number 800943001; surgical convenience kitSurgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- Class II
Medical Device Recall · December 18, 2023
PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H78712Rotating adaptor O-ring manufacturing defect impacting seal integrity which may lead to a leak during infusion of medication.
- Class II
Medical Device Recall · December 18, 2023
St. Jude Medical, Atrial Fibrillation Division, Inc.
TactiFlex Ablation Sensor Enabled Ablation Catheter, Models A-TFSE-FJ, 7.5 F shaft and an 8F distal section, Sterile.When the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and instead reads and displays it as a different model. This results in some features specific to the catheter do not appear on the display and the catheter image may also appear inverted.
- Class II
Medical Device Recall · December 18, 2023
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25Reason for the voluntary recall is residue was identified on the two forceps tips of a customer in Korea. The residue is associated with one lot of forceps tips which were utilized in two lots of ACTU8 Adaptive Forceps Tips occurring in 0.25% of those lots.