All Recalls

95,114 total recalls in our database

LOW PROFILE NON-LOCK SCREW; 2.7mm x 22 mm; REF 131227222; LOT RM105E. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.

Biomet

🏥 Medical Devices Class I - Dangerous

A Biomet investigation found that the Low Profile Non-Locking Screw 2.7mmx22mm screw (Part Number: 131227222 Lot: RM105E) was anodized green and should have been anodized gold per the print.

Mar 18, 2015 Infusion Pumps Nationwide View Details →

NobelReplace CC RP 5.0x10mm, Article No. 36711.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Other Medical Devices Nationwide View Details →

Bard ConQuest PTA Balloon Dilatation Catheter, 12mm Balloon Size, Product Code: CQ-75124.

Bard Peripheral Vascular

🏥 Medical Devices Class I - Dangerous

Bard Peripheral Vascular is recalling the Bard ConQuest PTA Balloon Dilatation Catheter because it may be at risk of having deflation related issues.

Mar 23, 2015 Surgical Instruments View Details →

NobelReplace CC RP 4.3x11.5mm, Article No. 36707.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Other Medical Devices Nationwide View Details →

Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing Safe-Cut Safety Scalpels.

Bard Access Systems

🏥 Medical Devices Class I - Dangerous

Potential for inadvertent scalpel stick injury involving the safety scalpel.

Jun 24, 2014 Surgical Instruments Nationwide View Details →

Replace Select Tapered TiU NP 3.5x13mm, Article No. 29402. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

NobelReplace CC PMC NP 3.5x11.5mm, Article No. 37287.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Other Medical Devices Nationwide View Details →

Replace Select Tapered TiU WP 5.0x10mm, Article No. 29423. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

Artis Q/ Q zen systems; Artis Q/ Q zen systems are dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

potential issue with the Artis Q/ Q zen systems where it is possible that an electrical connection in the equipment cabinet has not been installed correctly. The potentially defective connection in the equipment cabinet will be inspected and, if necessary, corrected.

Mar 19, 2015 Diagnostic Equipment Nationwide View Details →

NobRpl Tapered Groovy 6.0mm 6x11.5mm, Article No. 36103. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

Replace Select Tapered TiU NP 3.5x16mm, Article No. 29403. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

WALLACH LL 100 cryosurgical units: LL100 Cryosurgical - Part Number 900001; LL110 with Pinned Yoke - Part Number 900019-70; LL100 Multi Tip W/TC - Part Number: 900629; LL100 - CO2 - Part Number 900162

CooperSurgical

🏥 Medical Devices Class I - Dangerous

Internal gas line may malfunction causing the line to burst under pressure.

Mar 9, 2015 Surgical Instruments Nationwide View Details →

Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

Baylis Medical Corp *

🏥 Medical Devices Class I - Dangerous

Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

Mar 30, 2015 Surgical Instruments Nationwide View Details →

NobelReplace CC RP 5.0x13mm, Article No. 36713.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Other Medical Devices Nationwide View Details →

NobelReplace CC RP 4.3x13mm, Article No. 36708.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..

Mar 9, 2015 Other Medical Devices Nationwide View Details →

3i T3 Non-Platform Switched Tapered Implant Rx Only; 3.25 x 8.5 - 15.0 mm Dental Implants.

Biomet 3i

🏥 Medical Devices Class I - Dangerous

Endosseous Dental Implants in contact with a residual machine fluid caused the implants to be discolored.

Nov 7, 2014 Implants & Prosthetics Nationwide View Details →

Replace Select Tapered TiU NP 3.5x10mm, Article No. 29401. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Dental Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Dental Implants may be placed immediately and put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Implants & Prosthetics Nationwide View Details →

NobelReplace CC RP 5.0x8mm, Article No. 36710.

Nobel Biocare Usa

🏥 Medical Devices Class I - Dangerous

A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

Mar 9, 2015 Other Medical Devices Nationwide View Details →

Integra¿ Flowable Wound Matrix Size 3cc 1 unit/box single use, sterile device Rx Only Model Number FWD301 (US) & FDR301 (Non-US) Flowable Wound Matrix is comprised of the following components which are provided in a sealed and sterilized Tyvek / plastic tray: - An empty plastic syringe with Luer-Lok" tip - A plastic syringe with Luer-Lok" tip containing the Flowable Wound Matrix material - A syringe-to-syringe Luer-Lok" adapter / connector - A flexible plastic tube (injector) with Luer-Lok" connector Instructions for Use (IFU) and the sterilized package are subsequently packaged in a labeled and sealed box that is distributed to customers.

Integra LifeSciences

🏥 Medical Devices Class I - Dangerous

A lot of Flowable Wound Matrix that has been distributed to customers in late 2013 / early 2014 was verified as not meeting stability acceptance criteria for the attributes of visual appearance during dispensing and force vs. displacement (force needed for product to be extruded from the syringe).

Mar 13, 2015 Surgical Instruments View Details →