Medical Device Recalls

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7,959 medical device recalls from federal enforcement feeds.

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Showing 4,251–4,300 of 7,959

Medical Device Recall · December 10, 2024
Biocartis Nv
Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.
False-positive MSI-H results generated by the Idylla MSI Test.
Class II
Medical Device Recall · December 10, 2024
Encore Medical, LP
EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
Class II
Medical Device Recall · December 10, 2024
Mercury Enterprises, Inc. dba Mercury Medical
Neo-Tee T-Piece Resuscitator, for pediatric emergency respiratory support, Part: 1050805, 1050808, 1050809, 1050810, 1050811, 1050814, 1050832, 1050839, 1050840, 1050841, 1050842
Gas powered emergency resuscitator has a circuit flow controller manufactured with an undersized spring, which may cause resuscitator not reach the high and low ends of the PIP and PEEP pressure ranges, which may cause a loss of positive pressure, impacting effective ventilation of the patient.
Class I
Medical Device Recall · December 9, 2024
Maquet Cardiovascular, LLC
VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class I
Medical Device Recall · December 9, 2024
Maquet Cardiovascular, LLC
Vasoview Hemopro 2 (w/Vasoshield) Endoscopic Vessel Harvesting System. Model Numbers: VH-4001. Indicated for use in minimally invasive surgery allowing access for vessel harvesting.
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
Class I
Medical Device Recall · December 9, 2024
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L
Oxygen concentrator may melt or catch on fire during use.
Class I
Medical Device Recall · December 6, 2024
DDS Lab
Temporary Titanium Abutments
Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment, which may lead the titanium abutment fracture, which may risk loosening of the affixed restoration; fragments could also injure oral mucosa, and could be aspirated.
Class II
Medical Device Recall · December 6, 2024
GE Medical Systems, LLC
Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile Monitoring Solution components and will integrate into existing healthcare facil
There is a software issue that can result in the loss of patient monitoring on the Portrait Central Viewer Application after 425 days of continuous run-time.
Class II
Medical Device Recall · December 6, 2024
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class I
Medical Device Recall · December 5, 2024
QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Class II
Medical Device Recall · December 5, 2024
Waldemar Link GmbH & Co. KG (Mfg Site)
LINK MP Reconstruction System Neck Segment (with suture holes, standard, uncemented, L= 35 mm, CCD 126¿, Offset= 31 mm, Ti6Al4V, PoroLink, Taper 12/14. Item Number: 99-0984/32 Intended for rev
Error on the main label and the patient label. The labels indicate a size XXL, this is a standard-size neck segment.. All further information on the labels is correct (Length, CCD and Offset).
Class II
Medical Device Recall · December 5, 2024
Fresenius Medical Care Holdings, Inc.
Dialyzer Optiflux 160NRe
Potential for internal blood leaks due to cracked polyurethane
Class II
Medical Device Recall · December 5, 2024
QUIDEL ORTHO
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide
Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cause negatively biased digoxin results.
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Multiport, Models: 1) Model # WC77, 2) Model # WC77D (Demo), 3) Model # WC77R (Refurbished); used in conjunct
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
B. Braun Medical, Inc.
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Hillrom Temperature Management Controller, MP, Model # 2083516; used in conjunction with Warming Blankets and Mattresses.
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
Augustine Temperature Management, LLC
Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) Model # WC71, 2) Model # WC71R (refurbished); used in conjunction with Warming Blankets
Instructions for use update on HotDog Temperature Management Controllers Models WC71, WC77, and Temperature Management Controller MP Model 2083516 pertaining to Power-on self-test error code "EA POST".
Class II
Medical Device Recall · December 4, 2024
Medtronic Navigation, Inc.
Medtronic PIN, 100mm STERILE PERCUTANEOUS REF: 9733235 Medtronic PIN, 150MM, STERILE PERCUTANEOUS REF: 97733236 The Sterile Percutaneous Reference Pin Set is intended to be used to place and rem
Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE WEITLANER RETR SH 2X3 4.5"CS25, Model Numbers: 96-2201A; 2) ECONO STERILE WEITLANER RETR BL 2X3 4.5"CS25, Model Numbers: 96-220
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE PROBE W/EYE CS/50, Model Number 94-5923; 2) ECONO STERIL" PROBE W/EYE 5.5" STERL CS/25, Model Number 96-2361; orthopedic probe
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE GRAVES SPEC STRL SM BX/25, Model Number 96-2603; 2) ECONO STERILE GRAVES SPEC STRL MD BX/25, Model Number 96-2605; 3) ECONO S
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCHAMBERG EXTRCT SQ STER CS25, Model Number 96-2395M; blackhead extractor
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE S
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE HEGAR DILATOR 11&12MM STRLCS25Model Number 96-0960; 2) ECONO STERILE HEGAR DILATOR 9&10MM STRL CS25Model Number 96-0961; 3) ECO
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; gener
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Qualigen Inc
The FastPack IP Sex Hormone Binding Globulin Immunoassay, Part #25000081, is for the quantitative measurement of SHBG in human serum and plasma. For in vitro diagnostic Use and contains 30 FastPacks.
Three lots of the FastPacks kitted into the FastPack SHBG Complete Kits were labeled with the incorrect expiration date. The following is a listing of affected lots: Lot Number: 2408018-1, 2409015-1, and 2409015-2. The likelihood of patient harm is expected to be low as routine Quality Control should detect kits that are impacted by signal deterioration due to age.
Class III
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VEIN HOOK 1.5MM STERILE CS/25, Model Number 96-4020M; 2) ECONO STERILE VEIN HOOK 2MM STERILE CS/25, Model Number 96-4021M; 3) E
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SIMS UTERINE SND GRD 13"STER25, Model Numbers: 96-2478 (gynecological use)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, M
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STE
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE LEMPERT BONE RONG 6.25" STER25, Model Number 96-4780A; orthopedic surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IRIS HOOK QK REL 4MM 9" STER25, Model Number 96-2224A; eye surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE BLAKE GALLSTONE FCP CVD 8"CS25, Model Number 96-4921A
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Stryker Corporation
100V NEPTUNE 3 ROVER JAPANESE (0703-003-000) 120V NEPTUNE S ROVER (0711-001-000) 230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG) 230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES)
Bolts on the vacuum pump filter housing and the flange plate were not properly tightened, impacting the function of the Neptune rovers. Systems with loose bolts may fail to provide sufficient suction force or loss of suction during a procedure.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gyn
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO INFANT SPEC STRL CS/10, Model Number 96-3814; eyelid surgery
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Medicrea International
UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UN
Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect calculations displayed on system. Impacted parameters includes the following: Roussouly Classification, Real Lumbar Lordosis and Real Thoracic Kyphosis, Barrey Ratio, and Lenke Classification.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE SIMS UTERINE CURETTE #3 STER25, Model Number 96-4113; 2) ECONO STERILE KEVORK ENDO CURET W/BAS STER25, Model Number 96-4144A; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE OLSEN-HEG NH SMO DEL 5.5STER25, Model Number 96-2352A; 2) ECONO STERILE HALSEY NH SERR 5" STRL CS/25, Model Number 96-2353; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ARMY RETR (SET OF 2) STER CS25, Model Number 96-2243; 2) ECONO STERILE ARMY RETR (SET OF 2)STRL CS/25, Model Number 96-2243M; 3
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II
Medical Device Recall · December 3, 2024
Sklar Instruments
ECONO STERILE medical procedure kits labeled as: ECONO STERILE SCALPEL HDL #3 W/METRIC CS/25, Model Number 96-3500M
Reports of various packaging issues that may result in a breach of the sterile barrier.
Class II