Medical device recalls
39180 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2020-02-26FDA-DeviceAbbott Point Of Care Inc.Class IIi-STAT CHEM8+ cartridges (blue), List No. 09P31-25. UDI (01) 00054749001910 - Product Usage: The i-STAT CHEM8+ cartridge may be used for the quantitative measurement of sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine, and hematocrit in venous, arterial or capillary whole blood.
The I-STAT BLUE CHEM8+ and CG4+ cartridges are not FDA cleared and do not have CLIA waived status. CLIA recognizes two types of laboratory tests: waived and non-waived. Different CLIA standards apply to waived and non-waived tests as well as the facilities that perform these types of tests. The i-STAT CHEM8+ cartridge contains nine measured assays (sodium, potassium, chloride, blood urea nitrogen (BUN), ionized calcium, TCO2, glucose, creatinine and hematocrit) and is categorized as a CLIA waived test for venous whole blood samples, meaning this cartridge could be used in a facility with a CLIA Certificate of Waiver as a waived test.
- 2020-02-26FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIAtellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay
Atellica CH: The Atellica¿ CH High Sensitivity CReactive Protein Calibrator (hsCRP CAL) is for in vitro diagnostic use in calibrating the hsCRP assay using the Atellica¿ CH Analyzer.
- 2020-02-26FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage: For in vitro diagnostic use in the calibration of ADVIA¿ Chemistry systems for the CardioPhase¿ hsCRP assay.
Atellica and ADVIA hsCRP calibrator accuracy has drifted away from the reference materials (ERM-DA470/IFCC), which is causing a high bias on QC and patient sample recovery.
- 2020-02-26FDA-DeviceAdvanced Bionics, LLCClass IIIHiResolution Bionic Ear System HiRes 90K Advantage CI HiFocus MS Electrode REF CI-1500-04. Cochlear Implant.
Three materials used in the makeup of the implant were mistakenly left off the list of bio-compatible materials in the firm's previously approved submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan.
- 2020-02-26FDA-DeviceOrmco/SybronendoClass IISnapLink, Ref Part No. 438-2191, L6L SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
- 2020-02-26FDA-DeviceOrmco/SybronendoClass IISnapLink, Ref Part No. 438-2190, L6R SnapLink, Slot .022, TQ--28, Ang +2, Rot +2, Qty 10, Made in Mexico, CE 0086, Rx Only
The action is being taken due to an increase in complaints relating to the lower buccal tube slide doors not staying close. In the event of functional failure, broken/damage buccal tubes it may cause the tooth to rotate, possibly delay treatment and inconvenience the patient and clinician. If not noticed it may extend treatment by approximately 1 -3 months.
- 2020-02-26FDA-DeviceEdan DiagnosticsClass IIEDAN Telemetry Transmitter, Model iT20 - Product Usage: The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.)
Firm became aware that it distributed 7 units in the U.S. that included a function that had not been cleared by U.S. FDA.
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow Pressure Injectable Two-Lumen PICC Kit 5 Fr. x 50 cm EU-05052-HPMSB
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIPICC Set- PR-35052-HPHNM
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass II(1) Arrow¿ STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow¿ STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow¿ STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow¿ STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow¿ STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow¿ INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow¿ STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL NEEDLE KIT SL-05500
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL CATHETERIZATION COMPONENT EC-05000
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow SPINAL ANESTHESIA SET ASA-25090-S
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL CATHETERIZATION KIT CK-02220
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL CATHETERIZATION KIT AM-05500
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL CATHETERIZATION KIT JH-05500
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL CATHETERIZATION KIT YC-02220
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow¿ EPIDURAL CATHETERIZATION KIT AK-05000
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow EPIDURAL NEEDLE COMPONENT AN-05505
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow Central Venous Catheterization Kit ASK-04200-UPM
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow PSI Kit for use with 7 - 7.5 Fr. Catheters ASK-09801-UPM
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow StimuCath(R) Continuous Nerve Block Kit ASK-05060-CHO1
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow Maximal Barrier Drape ASK-00002-1A
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow FlexTip Plus(R) Combined Spinal Epidural Catheterization Kit ASK-05560-WH
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05500-CAN
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-17019-MSC
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceArrow International IncClass IIArrow FlexTip Plus(R) Epidural Catheterization Kit ASK-05400-CA1
Product lidstock contains the incorrect expiration date for the product
- 2020-02-26FDA-DeviceCardinal Health 200, LLCClass IIPresource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.
The kits contained recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection.
- 2020-02-26FDA-DeviceMedicrea InternationalClass IIMedicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
- 2020-02-26FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIDimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
There is a potential for falsely depressed creatinine results for patients on phenindione therapy when using the enzymatic methodology. Interference has not been observed with the creatinine Jaffe methodology.
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