Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
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Surgical Instruments
🏥 Medical Devices • 100 recalls
100 Class I
0 Class II
0 Class III
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Bard Peripheral Vascular
Class I - Dangerous
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
Medline Industries
Class I - Dangerous
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing BD Luer Tip Caps. BD has issued a recall of their Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Although the tip cap covers a small surface area of the syringe and does not come in direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis depending on the nature and duration of contact with the syringe.
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
Fresenius Kabi USA
Class I - Dangerous
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
Class I - Dangerous
Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Medline Renewal LigaSure Exact, Dissector without Nano-Coating 21cm FT10 SW Version 4.0.1.15 or lower; Electrosurgical Cutting And Coagulation Device
Medline Industries
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Sterility compromised from small holes that may occur during packaging of the device pouches into the shelf carton and/or during transportation of the shelf carton.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
Class I - Dangerous
Medline Renewal has determined that certain areas on the device have the potential to trap residual material, which may remain within the device and, in rare cases, become dislodged.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;
Mozarc Medical US
Class I - Dangerous
A potential issue with the seal integrity of header bag packaging.
Due to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may inadvertently enter the wound
TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Product Number (Catalog Number): EM-2025-000F Rev 00 or Rev 01;
Integra LifeSciences Corp. (NeuroSciences)
Class I - Dangerous
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for visual verification of device location within the patient s anatomy.
Potential for contamination with cotton fibers.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented reality
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software version SPR.1.2.0, orthopedic augmented reality
Surgical Theater
Class I - Dangerous
A software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any secondary image layer(s) to the primary image layer.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Due to incomplete seals in the pouch which provide the sterile barrier.
Potential for contamination with cotton fibers.
Due to incomplete seals in the pouch which provide the sterile barrier.
Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Number EMZ111240. Prefilled saline flush syringes
Medline Industries
Class I - Dangerous
Medline has identified a limited quantity of saline IV flush syringes that may not meet the required concentration of sodium chloride.
Class I - Dangerous
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Class I - Dangerous
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
BD Phoenix M50 Instrument, labeled as the following: 1. BD Phoenix M50 Automated Microbiology System, Catalog Numbers: 443624, 44362409.
Becton Dickinson &
Class I - Dangerous
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Potential for compromised integrity of the sterile packaging.
Potential for compromised integrity of the sterile packaging.
Class I - Dangerous
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 605 mm x 100 ¿m
CORNEAT VISION
Class I - Dangerous
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for the lid of the catheter connector to be in the incorrect position.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood flow and other devices within the heart. Medline Item Numbers D087031RH
Medline Industries
Class I - Dangerous
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual particulates on patient-contacting surfaces are used, there is a potential risk of an inflammatory response or systemic infection, and if particulate were to dislodge during use and contact circulating blood and/or the heart, it may produce a granulomatous reaction or thrombus formation, which may lead to cerebral or pulmonary embolism, or deep vein thrombosis.
Class I - Dangerous
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034
Stryker Communications
Class I - Dangerous
Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
Extractor Pro RX Retrieval Balloon Catheter; UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above);
Boston Scientific
Class I - Dangerous
The product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and vice versa.
Their is the potential for weak staining which may result in false negative CD20 identification.
Class I - Dangerous
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class I - Dangerous
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Their is the potential for weak staining which may result in false negative CD20 identification.
Their is the potential for weak staining which may result in false negative CD20 identification.
Class I - Dangerous
Foley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection control coating, when it's silicone hydrogel with antimicrobial coating, or 3)Natural latex with infection control, when it's silicone hydrogel coated without antimicrobial coating, which may cause infection and/or local and/or systemic allergic reaction
Class I - Dangerous
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
ViziShot 2FLEX. Single Use Aspiration Needle. Model Number: NA-U403SX-4019. The ViziShot 2 FLEX tissue biopsy device is made up of four main parts: a handle, a sheath, a needle, and a stylet. The sheath and needle are attached to the handle, and the stylet, which is removable, is located inside the needle tube.
Olympus Corporation of the Americas
Class I - Dangerous
Potential for undetected, deformed a-traumatic tips.
Class I - Dangerous
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x 6.5 mm x 100 um, SterileEO, RX only
CORNEAT VISION
Class I - Dangerous
Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would dehiscence.
Class I - Dangerous
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12110 LV VENT 10FR, Model Number 12110
Medtronic Perfusion Systems
Class I - Dangerous
The catheters may not retain their shape.
Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump
Baxter Healthcare
Class I - Dangerous
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12115 LV VENT 15FR, Model Number 12115
Medtronic Perfusion Systems
Class I - Dangerous
The catheters may not retain their shape.
Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump
Baxter Healthcare
Class I - Dangerous
Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Large Volume Pump (LVP) and Novum IQ Syringe Pump (SP) due to software anomalies that may result in a blank Run screen (LVP and SP) and/or false motor movement system error (SP only).
Packaging failures were identified which could lead to a breach in the sterile barrier.
DLP Left Heart Vent Catheter Malleable body and vented connector, SUCTION 12113 LV VENT 13FR, Model Number 12113
Medtronic Perfusion Systems
Class I - Dangerous
The catheters may not retain their shape.
Due to out of the box wobble of the driver.
Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydronephrosis.
Class I - Dangerous
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Injection needle, bayonet, Luer-Lock, 1. Model no. 50-353-23, working length 25 cm, total length 31cm, nonsterile; 2. Model no. 50-345-23, working length 24 cm, total length 31 cm, non-sterile
Spiggle & Theis Mt Gmbh
Class I - Dangerous
Affected product show elevated cytotoxicity values. Use of affected injection needles may present a risk of intolerance reaction or allergic reaction.
Class I - Dangerous
The potential for unsterilized product within finished product labeled as sterile.
Class I - Dangerous
Potential for the ESG-410 Electrosurgical Generator to display an error message: "E0662 System Error", followed by either automatic single reboots of the device, or continuous reboot 'loops'.
Device contains indications for use and device compatibility claims that have not be reviewed and approved for safety and effectiveness by the FDA. Instructions for use are not consistent with product training.
Class I - Dangerous
Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging