Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 2,701–2,750 of 7,959
- Class II
Medical Device Recall · July 21, 2025
Brand Name: CELSITE Product Name: CELSITE BABYPORT SET PUR 4,5F IV USA Model/Catalog Number: 5433742 Software Version: N/A Product Description: CELSITE BABYPORT SET PUR 4,5F IV USA Component: N/AThe potential for minor injury such as damage to the vessel and/or tearing of the vessel wall.
- Class II
Medical Device Recall · July 21, 2025
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of tPotential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Class II
Medical Device Recall · July 19, 2025
Brand Name: Ultra IABP Catheter Kit Product Name: Ultra IABP Catheter Kit Model/Catalog Number: IMU7F-40, IMU7F-35, IMU7F-30, IMU7F-25, and IMU7F-20 Software Version: Not applicable Product DescriDevice 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 II
Medical Device Recall · July 18, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product Description: Material: S.S., Non SterileTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
- Class II
Medical Device Recall · July 18, 2025
Brand Name: DJO SURGICAL Product Name: FA S Altivate Reverse Glenoid Tray Model/Catalog Number: None Software Version: NA Product Description: Enovis" shoulder devices are intended for treatment oTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
- Class II
Medical Device Recall · July 18, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER HEAD Model/Catalog Number: 804-06-311 Product Description: Material: S.S/Nitronic, Non-SterileTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
- Class II
Medical Device Recall · July 18, 2025
Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER SLEEVE Model/Catalog Number: 804-06-310 Product Description: Material: S.S/CoCrMo, Non-SterileTheir is a potential that the reamer may kick or bind up during or immediately prior to use.
- Class II
Medical Device Recall · July 17, 2025
SureStep Foley Tray System Lubri-Sil I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303414AFoley 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 II
Medical Device Recall · July 17, 2025
SureStep Foley Tray System BARD¿ Lubri-Sil Foley Catheter Tray, REF: A942216Foley 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 II
Medical Device Recall · July 17, 2025
Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Class II
Medical Device Recall · July 17, 2025
Philips Medical Systems (Cleveland) Inc
Pinnacle 3 with TumorLOC, (870258) Radiation Therapy Planning System SoftwareDue to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ,
- Class II
Medical Device Recall · July 17, 2025
SureStep Foley Tray System Bardex I.C. Complete Care Infection Control Foley Catheter Tray, REF: A303316AFoley 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 II
Medical Device Recall · July 17, 2025
Brand Name: ReQuest Measles IgM Product Name: Enzyme Linked Immunoabsorbant Assay, Rubeola IgM Model/Catalog Number: 01-190M Software Version: N/A Product Description: Measles IgM tests, performedMeasles IgM Test Kit lacks premarket approval or clearance.
- Class II
Medical Device Recall · July 17, 2025
IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834. The IPC POWEREASE System is indicated for drilling, tapping, and driving screws and working end attachments during spinalDue to out of the box wobble of the driver.
- Class II
Medical Device Recall · July 16, 2025
Dynex Agility Sample Tips; Model Number: 67910; The 67910 Agility Sample Tips are an accessory/consumable used with the Agility Automated ELISA system.The internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack is misidentified as a different tip type, rendering it incompatible with the system and preventing use which causes a delay in obtaining patient results.
- Class II
Medical Device Recall · July 16, 2025
TOPS Inserter, part of the TOPS System Instrument Set used for implantation of the TOPS System. Model Number: 82889.Potential for missing pins at tip of inserter.
- Class II
Medical Device Recall · July 16, 2025
Pentax Medical Video Processor; Model Number: EPK-i8020c;During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s mucous membrane.
- Class II
Medical Device Recall · July 15, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Plastic Trial Head Brown, 7 mm neck length. Item Number: 175-928/15.Inconsistent size terminology and color coding used on labeling
- Class II
Medical Device Recall · July 15, 2025
Chromophare Surgical Light System, REF: CH00000001; SLX to Oculan NFC Upgrade Kit, REF: P60034Surgical lights have stress lines forming on the powder coating, which indicates that powder coating chipping can occur.
- Class II
Medical Device Recall · July 15, 2025
Waldemar Link GmbH & Co. KG (Mfg Site)
Prosthesis Head B, 28 mm, 7 mm neck length. Item Number: 198-828/04.Inconsistent size terminology and color coding used on labeling
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) SFCH CRANI PACK (PS 132432), MODEL/ITEM NUMBER UICR10W; 2) SFCH SHUNT PACK (PS 139798), MODEL/ITEM NUMBER UISH55V.During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.Under certain conditions, such as the simultaneous use of the operating table with other medical devices, including high-frequency (HF) surgical equipment, interference may occur that could prevent the device from performing as intended. If the issue occurs, the operating table is unresponsive to command from both the universal remote control and override panel.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
Spectrum IQ Infusion Pump, Product Code 3570009Baxter has identified that certain pumps have potentially been released with the grease applied to the cam and motor gears that will break down quickly. The breakdown of the grease will lead to the device having insufficient or ineffective grease applied to the cam, which could lead to premature wear of the mechanism assembly, resulting in excessive therapy.
- Class I
Medical Device Recall · July 14, 2025
MEDLINE INDUSTRIES, LP - Northfield
Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic Electrophysiology Catheter Models 401150RH, 401206RH, 401207RH, 401210RH, 401211RH, 401212RH, 401222RH, 401223RH, 401226RHSpecific lots of reprocessed electrophysiology catheters may contain small residual particulates.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) CYSTO, Model/Item Number ASCY24A; 2) CYSTO PACK, Model/Item Number BUCY78E; 3) CYSTO PACK, Model/Item Number LMCP22T;During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ANTERIOR HIP PACK, MODEL/ITEM NUMBER AMAH40N; 2)TOTAL KNEE DAN MYER, MODEL/ITEM NUMBER CCKM67F; 3)HIP PROTHESIS PACK,During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class I
Medical Device Recall · July 14, 2025
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUSBaxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) due to the potential for underinfusion when transitioning from a flow rate to a higher flow rate that is more than double. (e.g., rate change or bolus). The level of underinfusion is variable based on the current infusion rate, the duration the pump has been running at this flow rate, and the magnitude of the rate change. The longer the duration the pump has been running at the current infusion rate and the larger the magnitude of the rate change, the larger the underinfusion that would be experienced. Additionally, Baxter has identified an increase in customer reports of over and underinfusion potentially due to set misloading. Failure to properly load the tubing into the pump channel may result in the pump infusing at a rate higher or lower than programmed. Consistent with the instructions for use, customers should ensure that: 1) The door is fully open before loading the set. 2) The tubing is taut and loaded without slack in the pumping channel.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) A-C SUPPLEMENT PACK - 205946, Model/Item Number ANCV67X; 2) KIDNEY PERFUSION PACK - 208439, Model/Item Number ANKP15AD;During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
3mensio Workstation (Vascular Fenestrated) softwareWhen fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular structures) and the 12h position of a single clock is changed, other clock measurements are not updated relative to the new 12h position which may cause stent graft fenestrations at incorrect position, which may lead to blood flow disruption and tissue damage
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) ROBOT HYST PACK, MODEL/ITEM NUMBER GRRB10E; 2) VAG HYST PACK, MODEL/ITEM NUMBER SPVH62P.During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) HEART PACK - 205947, MODEL/ITEM NUMBER ANCV78BC; 2) VASCULAR PACK - 232024, MODEL/ITEM NUMBER ANVA82AB; 3) OFF PUMP CADuring an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAP CHOLE PACK, Model/Item Number CILC69L; 2) LAP CHOLE PACK, Model/Item Number HNLC80J; 3) LAP CHOLE PACK, Model/ItemDuring an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class II
Medical Device Recall · July 14, 2025
AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) LAPAROSCOPY PACK, MODEL/ITEM NUMBER EVLP61I; 2) PELVISCOPY, MODEL/ITEM NUMBER EVPV29G.During an internal investigation, ACS determined that the rationale for sterilization of certain components was not justified and therefore, some components are not fit for further sterilization according to ACS procedures. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Handle and Blade Refs: 040-331U (Mac 1), 040-332U (Mac 2), 040-333U (Mac 3), 040-335U (Mac 3.5) 040-334U (Mac 4), 040-341U (Miller 1), 040-342U (MillerLaryngoscope handles may not illuminate as intended.
- Class II
Medical Device Recall · July 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Mini Single-Use Fiber Optic Laryngoscope Handle REF:040-309ULaryngoscope handles may not illuminate as intended.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Mini Handle and Blade Ref: 040-02-0110U (Mac 1), 040-02-0120U (Mac 2), 040-02-0130U (Mac 3), 040-02-0131U (Mac 3 Strong Curve) 040-02-0140U (Mac 4), 040-Laryngoscope handles may not illuminate as intended.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
Britepro Solo Stubby Single-Use Fiber Optic Laryngoscope Handle REF:040-03-0000ULaryngoscope handles may not illuminate as intended.
- Class II
Medical Device Recall · July 11, 2025
Blood/EMB, Levine 100/PK, Product Number R02041The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Class II
Medical Device Recall · July 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS BOWED CANAL FILLING STEMS. Canal filling stem implants.Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Class II
Medical Device Recall · July 11, 2025
Blood Agar,5% Sheep Blood 100/PK, Product Number R01202The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Class II
Medical Device Recall · July 11, 2025
ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS SEGMENTAL STEM CANAL FILLING STRAIGHT SLOTTED SPLINED 2/3 PLASMA. Canal filling stem implants.Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.
- Class I
Medical Device Recall · July 11, 2025
Plum Duo Infusion System, List Number: 400020401ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Mini with Pro Miller Blade Size 1.5, REF:040-02-0415ULaryngoscope handles may not illuminate as intended.
- Class I
Medical Device Recall · July 11, 2025
Flexicare Medical (Dongguan) Ltd.
BritePro Solo Single-Use Fiber Optic Laryngoscope Handle Refs:040-310AU and 040-310ULaryngoscope handles may not illuminate as intended.
- Class II
Medical Device Recall · July 11, 2025
Blood/MacConkey Biplate 100/PK, Product Number R02049The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Class II
Medical Device Recall · July 11, 2025
Strep Selective II Agar, Product Number R01859The products may contain surface and subsurface contamination of Listeria monocytogenes.
- Class I
Medical Device Recall · July 10, 2025
Multi Joystick R-net. Electrical wheelchair component.Devices with firmware versions 2.3 and lower may experience timing variations between software tasks, which could result in skipping the necessary neutral check and the wheelchair producing unintended movement upon power-up when the joystick is out of neutral.
- Class II
Medical Device Recall · July 10, 2025
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860Access Thyroglobulin reagent lot 439163 may generate erroneously high patient results. Falsely increased Access Thyroglobulin results may lead a physician to pursue unnecessary diagnostic imaging studies and/or inappropriate therapy adjustments in patients being monitored for residual or recurrent thyroid cancer.