🔍 RecallPedia

All Recalls

95,083 total recalls in our database

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28,983
Food
 💊
17,685
Drugs
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38,779
Medical Devices
 🏠
9,636
Consumer Products

STERRAD NX Sterilization System, Product Code: 10033, 10033-002

Advanced Sterilization Products

🏥 Medical Devices Class I - Dangerous

Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following an external power outage, the system door interlock can be become disengaged during system reboot for a 20-second duration.

Jan 9, 2017 Other Medical Devices Nationwide View Details →

Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No: 32-487263, 75 MM Item No: 32-487264, and 79 MM Item No: 32-487265

Zimmer Biomet

🏥 Medical Devices Class I - Dangerous

Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.

Dec 15, 2016 Implants & Prosthetics View Details →

ONCOR Avant-garde, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Jan 25, 2017 Infusion Pumps View Details →

Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Atrium Medical

🏥 Medical Devices Class I - Dangerous

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Dec 23, 2016 Infusion Pumps Nationwide View Details →

ARTISTE MV System, medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Jan 25, 2017 Infusion Pumps View Details →

The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) on the Dimension¿ clinical chemistry system. For prescription use only.

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

Complaints of positive shift of patient and QC results when the ALTI assay is calibrated with the Dimension Enzyme II calibrator. Internal investigation has confirmed that patient samples and QC material demonstrate a shift of up to 10% in comparison to results obtained using earlier calibrator lots.

May 5, 2016 Diagnostic Equipment View Details →

LIMA Modular Revision Hip Stem Model 428-01-050_110 Product Usage: The Modular Revision Femoral hip stem is made up of a modular stem coupled with a proper neck by means of a Morse taper stabilized during the implantation phase by a safety screw. This system is particularly indicated for revision surgery on both uncemented and cemented femoral implants, when there is significant bone loss and an abnormal meta-epiphyseal anatomy of the femur.

Encore Medical

🏥 Medical Devices Class I - Dangerous

Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization.

Jan 10, 2017 Implants & Prosthetics Nationwide View Details →

PRIMUS Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Jan 25, 2017 Infusion Pumps View Details →

ONCOR Impression, ONCOR Impression plus, and ONCOR Expression Medical charged-particle radiation therapy system Product Usage: The intended use of the SIEMENS branded PRIMUS family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

Siemens became aware of Incorrect values for the rotational collimator position displayed due to mechanical problems of the sensor slide. In addition, there are improper weld seam at the overhead suspension.

Jan 25, 2017 Infusion Pumps View Details →

Maquet Oasis Dry Suction Water Seal Chest Drain, Single Collection w/AC Reference: 3600-100 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area

Atrium Medical

🏥 Medical Devices Class I - Dangerous

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Dec 23, 2016 Infusion Pumps Nationwide View Details →

BrightView X upgraded to XCT 882454

Philips Medical Systems (Cleveland)

🏥 Medical Devices Class I - Dangerous

The intended use listed in the English and localized language IFUs for BrightView XCT systems did not match the intended use documented in the 510K submission.

Dec 23, 2016 Other Medical Devices Nationwide View Details →

Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 Intended Use: To evacuate air and/or fluid from the chest cavity or mediastinum. " To help re-establish lung expansion and restore breathing dynamics. " To facilitate postoperative collection and reinfusion of autologous blood from the patients pleural cavity or mediastinal area.

Atrium Medical

🏥 Medical Devices Class I - Dangerous

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

Dec 23, 2016 Infusion Pumps Nationwide View Details →

Arthrex Shoulder Suspension Tower; Catalog Number: AR-1650-01 Product Usage: The Arthrex Lateral Decubitus Shoulder Positioner is intended to allow for the controlled manipulation of the arm and shoulder joint during arthroscopic surgical procedures.

Allen Medical Systems

🏥 Medical Devices Class I - Dangerous

During use, there is a potential scenario which could allow the fastening screws attaching covers to come loose and potentially land in the sterile field causing a delay in surgery.

Jan 3, 2017 Implants & Prosthetics View Details →

T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens

Argon Medical Devices

🏥 Medical Devices Class I - Dangerous

The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray.

Jan 18, 2017 Surgical Instruments Nationwide View Details →

6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

Acumed

🏥 Medical Devices Class I - Dangerous

The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135  Ti alloy) and was distributed.

Jan 19, 2017 Implants & Prosthetics View Details →