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Medical Devices Recalls

Medical equipment, implants, and diagnostic devices

38,779 Total Recalls

regard Item Number: 800535, Sterile, LD0620 - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800615, Sterile, CV0741 - Peripheral Vascular - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800409, Sterile, GS0478 - LAP Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

MICroSTREP plus 1 Panel, Part No. B1027-201 Product Usage: MicroScan MICroSTREP plus panels are designed for use in determining quantitative and/or qualitative antimicrobial agent susceptibility of colonies grown on solid media of aerobic streptococci, including Streptococcus pneumoniae.

Beckman Coulter

Class I - Dangerous

Beckman Coulter is recalling MICroSTREP plus 1 and MICroSTREP plus 2 panels because a manufacturing error may lead to antimicrobic degradation and the potential for elevated or false resistant results.

Sep 10, 2015 Infusion Pumps Nationwide View Details →

Zimmer Universal Locking System, Titanium 3.5mm. Zimmer Implant and Instrument Cases are reusable, non-implantable devices designed to facilitate organization, identification, storage, transportation, cleaning, and sterilization processing of reusable instruments and certain unused implantable devices.

Zimmer

Class I - Dangerous

It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat

Aug 11, 2015 Implants & Prosthetics View Details →

regard Item Number: 800036002, Sterile, LD0274B - C Section Pack - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

Disposable Paper Filter for Sterilization Containers Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed in the USA by: Stryker Orthopedics, NON STERILE.

Stryker Craniomaxillofacial Division

Class I - Dangerous

Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.

Sep 17, 2015 Other Medical Devices View Details →

regard Item Number: 800411002, Sterile, NU0480B - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800533, Sterile, GS0606 - Abdominal Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Implants & Prosthetics View Details →

regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800532, Sterile, GY0616 - Vaginal Hysterectomy - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800411001, Sterile, NU0480A - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 880327, Sterile, CV0758 - Open Heart A&B - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800565, Sterile, CV0654 - Pediatric Heart - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

regard Item Number: 800549, Sterile, ET0638 - Head & Neck - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical procedure

Resource Optimization & Innovation

Class I - Dangerous

The kits contain an equipment glove component which may contain splits or holes compromising the sterility.

Apr 22, 2015 Surgical Instruments View Details →

Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is used in both primary and revision P.F.C.¿ SIGMA¿ knee procedures to align the femoral locating device and distal femoral cutting block. It is also used with the IM tibial resection. This rod is included with the P.F.C.¿ SIGMA¿ Specialist¿ 2 (SP2 / SPII) Primary Knee Instruments, the P.F.C.¿ SIGMA¿ Specialist ¿ 2 (SP2 / SPII) Revision Knee Instruments, and P.F.C. ¿ SIGMA¿ High Performance (HP) Primary Knee Instruments

DePuy Orthopaedics

Class I - Dangerous

DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.

Sep 8, 2015 Implants & Prosthetics Nationwide View Details →