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.

2020-11-11FDA-DeviceGE Healthcare, LLCClass II
Flow Sensor Service Part, Catalog 2096513-001-S
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
Flow Sensor Service Part, Catalog 2087640-001-S
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
Flow Sensor Service Part, Catalog 2089610-001-S
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
9100c NXT system - Product Usage: Device is licensed and distributed outside of the US only.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
GE Datex-Ohmeda Aisys CS2 Anesthesia System - Product Usage: is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric adult). The device is intended for volume or pressure control ventilation.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
GE Datex-Ohmeda Avance CS2 Anesthesia System - Product Usage: intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients (neonatal, pediatric, adult). The device is intended for volume or pressure control ventilation.
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGE Healthcare, LLCClass II
Aestiva/5 MRI Anesthesia System - Product Usage: The Aestiva/5 MRI Anesthesia System provides the functional feature set offered by the conventional Aestiva/5 to the clinician with the added ability to be used in the MR environment. Among those standard Aestiva/5 features is the Datex-Ohmeda user interface, all the ventilation parameters of the SmartVent along with the Aestiva breathing circuit. The Aestiva/5 MRI Anesthesia System performed to specifications when tested directly next to 1.5 and
Flow sensors could have damaged tubes in the form of small punctures or cuts.
2020-11-11FDA-DeviceGenicon, Inc.Class II
A Li-Gator Single Use Laparoscopic Clip Applier, 10 mm X 29 cm - Product Usage: intended for use on tubular structures or vessel wherever a metal litigating clip is intended
Device malfunction causing the applier to jam, and clip loading failures.
2020-11-04FDA-DeviceBattelle Memorial InstituteClass II
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
2020-11-04FDA-DeviceExactech, Inc.Class II
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
2020-11-04FDA-DeviceExactech, Inc.Class II
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
2020-11-04FDA-DeviceGE Healthcare, LLCClass II
Revolution Apex, Revolution CT with Apex Edition, Model 5995000-5 - Product Usage: The system is intended for head, whole body, cardiac and vascular X-ray Computed Tomography applications.
There is a potential for a smudge artifact that could be suspect for pathology in some images due to incorrect settings.
2020-11-04FDA-DeviceCME America LLCClass II
CMEAmerica BodyGuard Wall Charger: Lot number 2019-0364, Mode/Catalogue number 151-143XL, *+B 01151143X L0/$$72019-0364/ 16D20191101/* Lot Number Label: BODYGUARD LOT 2019-0364 Manufacturing Date: 2019 - 11-01 , LABEL I.D. SM-0642 REV. 01, CMEAmerica Wall Charger Kit, REF 151-143XLP, Contents; Wall Charger, Instructions, +B101150143XLP0/$$7A23456/16D000112010, Manufactured By: CME America LLC, 14988 W. 6th Ave., Suite 830, Golden. CO 80401, USA, SM-0706 Rev 00 External Charger INPUT ;
The wall charger may not properly charge the infusion pump battery.
2020-11-04FDA-DeviceMicrobiologics IncClass II
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
QC Sets and Panels: KWIK-STIK 2 Pack (Catalog# 5226P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
2020-11-04FDA-DeviceMicrobiologics IncClass II
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
KWIK-STIK 6 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145K) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
2020-11-04FDA-DeviceMicrobiologics IncClass II
Each KWIK-STIK unit contains a lyophilized microorganism pellet, an ampoule of hydrating fluid, and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. KWIK-STIK microorganisms are 3 passages or fewer from the reference culture and are guaranteed to recover when processed using the recommended media and incubation requirements. Available in packs of 2 or 6.
KWIK-STIK 2 Pack Klebsiella pneumoniae derived from NCTC 13443 (Catalog# 01145P) should contain the NDM-1 positive strain, but was confirmed to be NDM-1 negative.
2020-11-04FDA-DeviceSmith & Nephew, Inc.Class II
5.5MM Arthrogarde Hip Access Cannula
The J Lock feature on the cannula body was manufactured incorrectly, preventing the cannula from locking into an irrigation extender or arthroscope in the correct orientation.
2020-11-04FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class II
Streamline TL Navigation System, Catalog Nos. 02-C-TAP-55-MDN 02-C-TAP-60-L-MDN 02-C-TAP-65-L-MDN 02-C-TAP-65-MDN 02-C-TAP-75-L-MDN 02-C-TAP-85-L-MDN 02-C-TAP-85-MDN 02-C-TAP-95-L-MDN 02-RS-INS-C-MDN 02-RS-INSERTER-MDN 02-SCREWINS-CL-MDN 02-SCREWINS-C-MDN 02-S-FINDER-L-MDN 02-SFINDER-MDN 02-S-FINDER-T-MDN 02-TAP-45-MDN 02-TAP-55-MDN 02-TAP-60-L-MDN 02-TAP-65-L-MDN 02-TAP-65-MDN 02-TAP-75-L-MDN 02-TAP-75-MDN 02-TAP-85-L-MDN 02-TAP-85-MDN 02-TAP-95-L-MDN 02-MODHANDLE-M
The Streamline Navigation System taps have experienced binding with other devices.
2020-11-04FDA-DeviceRTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)Class II
Streamline MIS Navigation System Taps, Catalog Nos. 04-CANNDRILL-MDN 04-CANNTAP-40-MDN 04-CANNTAP-45-MDN 04-CANNTAP-55-MDN 04-CANNTAP-65-MDN 04-CANNTAP-75-MDN 04-CANNTAP-85-MDN 04-CTAP-TT-65-MDN 04-S-FINDER-MDN 05-SCREWINS-CL-MDN 05-SIMPDRIVER-MDN Product Usage: intended to be used during the preparation and placement of screws from the Streamline TL and MIS Systems and preparation of screws from the Streamline OCT System during spinal surgery to assist the surgeon in precisely l
The Streamline Navigation System taps have experienced binding with other devices.
2020-11-04FDA-DeviceSiemens Medical Solutions USA, IncClass II
Siemens Artis one systems with a Display Port transceiver-Fluoroscopic X-Ray System Model: 10848600 - Product Usage: he examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. The Artis one can also support the acquisition of position triggered imaging for spatial data synthesis.
Potential malfunction in which the examination room monitor may become intermittently dysfunctional (e.g., no display/flicking/wrong resolution).
2020-11-04FDA-DeviceMedline Industries IncClass II
The Quidel Triage BNP Calibrators
Product compromised during shipment.
2020-11-04FDA-DeviceTHREAD COUNSEL INC DBA LAWS OF MOTIONClass II
LOM Disposable Surgical Gowns/Medical Gowns, Single-Use
Medical gowns distributed to customers did not include appropriate labeling, and some gowns may not meet FDA's standards for surgical gowns.
2020-11-04FDA-DeviceBecton Dickinson & CompanyClass II
Bard 3F SL PowerMidline Full Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153208
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-11-04FDA-DeviceBecton Dickinson & CompanyClass II
Bard 3F SL PowerMidline Basic Kit CE-indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media Ref: P6153118
Kits do not contain the stylet/T-lock assembly indicated as a component on the label, may lead to a procedural delay and possibly discard of the kit.
2020-11-04FDA-DevicePentax of America IncClass II
9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
2020-11-04FDA-DevicePentax of America IncClass II
9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal),
There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs.
2020-11-04FDA-DeviceW L Gore & Associates, Inc.Class II
GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
2020-11-04FDA-DeviceW L Gore & Associates, Inc.Class II
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
2020-11-04FDA-DeviceMerge Healthcare, Inc.Class II
Merge LIS
A defect in the software resulted in medications that are not associated with the patient (i.e., medications that the patient is not currently taking) appearing on their report.
2020-11-04FDA-DeviceBlue OrthoClass II
Instructions For Use document of the GPS Trackers.
Appropriateness of the language used in the Tracker reprocessing instruction. Reason is that some Low Temperature sterilization conditions mentioned in the IFUs are approved based on rational documents.

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