🔍 RecallPedia
ðŸĨ

Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.

The Anspach Effort

Class I - Dangerous

There was a potential for the Adaptor and Light Adaptor for Small Battery Drive and Small Battery Drive II to generate excessive internal pressure that may cause the products to burst.

Jun 24, 2016 Infusion Pumps Nationwide View Details →

Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.

Spacelabs Healthcare

Class I - Dangerous

The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.

Aug 25, 2016 Infusion Pumps Nationwide View Details →

Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.

CareFusion 303

Class I - Dangerous

A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.

Aug 8, 2016 Diagnostic Equipment Nationwide View Details →

PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. Intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local anesthetics.

Integra LifeSciences Corp. d.b.a. Integra Pain Management

Class I - Dangerous

Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.

Aug 24, 2016 Other Medical Devices View Details →

TECNIS OptiBlue 1-Piece Intraocular Lens (IOL), Model No. ZCB00V The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

Abbott Medical Optics Inc. (AMO)

Class I - Dangerous

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Aug 26, 2016 Implants & Prosthetics Nationwide View Details →

RENASYS Sterile Transparent Film and all the RENASYS Dressing kits that contains the RENASYS Sterile Transparent Film Is intended for patients who would benefit from a suction device (negative pressure) to help promote wound healing by removing fluids including irrigation and body fluids, wound exudates and infectious materials. Examples of appropriate wounds types include chronic, acute, traumatic, Sub-Acute and dehisced wounds, ulcers, (such as pressure and diabetic), partial thickness burns, flaps and grafts.

Smith & Nephew

Class I - Dangerous

Sterility seal integrity failures on the Renasys Sterile Transparent Film

Jul 21, 2016 Infusion Pumps Nationwide View Details →

LifeCare PCA Infusion System with Hospira MedNet Software, PCA Serial List Number 20709 Allows for clinician administration or self-administration of analgesic medications.

Hospira

Class I - Dangerous

Screw rotation error occurring when the pump detects a mismatch between the number of steps given to the motor driving delivery and the number of steps the motor actually took. When this malfunction occurs, the pump will alarm and infusion stops.

Mar 8, 2013 Infusion Pumps Nationwide View Details →

TECNIS 1-Piece IOL with the TECNIS iTec Preloaded Delivery System, Model No. PCB00 The product is indicated for implantation for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed by extracapsular cataract extraction. The lens is intended to be placed in the capsular bag.

Abbott Medical Optics Inc. (AMO)

Class I - Dangerous

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Aug 26, 2016 Implants & Prosthetics Nationwide View Details →

TECNIS Symfony Extended Range of Vision IOL, Model No. ZXR00 The product is indicated primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction, and aphakia following refractive lensectomy in presbyopic adults, who desire useful vision over a continuous range of distances including far, intermediate and near, and increased spectacle independence. The lens is intended to be placed in the capsular bag.

Abbott Medical Optics Inc. (AMO)

Class I - Dangerous

Abbott Medical Optics is recalling Intraocular Lenses (IOLs) because they were not being checked prior to release and this may result in the release of mislabeled IOLs.

Aug 26, 2016 Implants & Prosthetics Nationwide View Details →