🔍 RecallPedia

All Recalls

95,050 total recalls in our database

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28,983
Food
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17,685
Drugs
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38,779
Medical Devices
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9,603
Consumer Products

Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.

Guangzhou Improve Medical Instruments Co.

🏥 Medical Devices Class I - Dangerous

Complain due to the hub needle came out when the nurse draw the blood and removed the tube.

Sep 22, 2017 Surgical Instruments Nationwide View Details →

TriMed Hex Cortical Screw 4.0, 40 mm, REF HEX4.0-40, non-Sterile, RX, a component of the TriMed Ankle Fixation System. The HEX4.0 40 bone screw is a component of the TriMed Ankle Fixation System. The HEX4.0-40 Screw is a single piece machined cortical bone screw. The HEX4.0-40 screw is employed in combination with a TriMed Ankle Bone Plate such as a Sidewinder Plate, Ankle Hook Plate, Cluster, Semi-Tubular Plate, or the Locking Plate. Use of these implants is not a substitute for normal tissue healing. The TriMed Ankle Bone Plates and Screws are designed to provide additional constraint of movement of a fractured bone and are intended only as an aid to fix the fracture in place during the healing process.

TriMed

🏥 Medical Devices Class I - Dangerous

The bone screw is shorter than the intended design specification.

Aug 24, 2018 Implants & Prosthetics View Details →

RT Elements Software revisions of the RT Elements applications have a specific software version number. Specifically the following RT Elements applications/versions are affected: - Cranial SRS 1.0.0 and 1.5.0 - Spine SRS 1.0.0 and 1.5.0 - Multiple Brain Mets SRS 1.5.0 - RT QA 1.0.0 and 1.5.0 Product Usage: The RT Elements are applications for radiation treatment planning for use in stereotactic, conformal, computer planned, Linac based radiation treatment of cranial, head and neck and extracranial lesions.

Brainlab AG

🏥 Medical Devices Class I - Dangerous

There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.

Mar 11, 2019 Other Medical Devices Nationwide View Details →

Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.

Exactech

🏥 Medical Devices Class I - Dangerous

2.5 Truliant Fit Trays were mismarked as 3

Mar 13, 2019 Implants & Prosthetics Nationwide View Details →

St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

Abbott

🏥 Medical Devices Class I - Dangerous

The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.

Nov 19, 2018 Diagnostic Equipment Nationwide View Details →

Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm 5/pkg Product Code/REF Number: 6685775 Product Usage: The Edi Catheter is a single-use naso-gastric feeding tube with an electrode array of ten electrodes. The Edi Catheter is intended for: - Detecting diaphragmatic electrical activity, (Edi signals) by which the two ventilator modes NAVA and NIV NAVA can be controlled. - Detecting diaphragmatic electrical activity, (Edi signals) by which the respiratory drive from the brain can be monitored. - administrating nutrition, fluids and medications by the naso-gastricenteric route.

GETINGE US SALES

🏥 Medical Devices Class I - Dangerous

Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes

Mar 20, 2019 Diagnostic Equipment Nationwide View Details →

Fresenius Kabi CATSmart device (Continuous autotransfusion System). Labeled as the following kits: 1. AT-1 sets and kits (9005104 AT-1 Autotransfusion set, 9108504 ATF 120 Fast Start Kit, and 9108494 ATF 40 Fast Start Kits); 2. AT-3 Autotransfusion sets and kits (Part 9005444 AT-3 set, 9104444 ATF-120 Fast Start Kits (AT-3), or 9108444 ATF-40 Fast Start Kits AT-3) Product Usage: The Fresenius Kabi CATSmart device (Continuous auto transfusion System) is indicated for the processing of autologous shed blood collected interaoperatively and postoperatively to obtain washed packed red blood cells for reinfusion. The CATSmart Auto transfusion System is designed to reduce the need for allogeneic blood transfusion by re-infusing a patient s own lost blood during surgery. The set is used as a disposable component of the autotransfusion system during surgery and/or treatment of trauma to remove waste and improve the safety of autologous re-infused blood (auto transfusion). This is a single-use device.

Fenwal

🏥 Medical Devices Class I - Dangerous

Based on internal investigations, Fresenius Kabi has identified a multifaceted set of events involving the CATSmart Systems, including the device, software, and disposable which may result in the centrifuge tubing line making contact with the washing chamber. The contact may result in excessive wear of the centrifuge tubing or in extreme cases a puncture of the tubing.

Mar 5, 2019 Infusion Pumps Nationwide View Details →

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the risk of accidental secondary needle sticks.

Smiths Medical ASD

🏥 Medical Devices Class I - Dangerous

Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.

Aug 22, 2018 Surgical Instruments Nationwide View Details →

Performance Series Sagittal Blade, Catalog Number 6125-127-100 Product Usage: The Stryker Heavy Duty Sagittal Blades are used in the cutting and shaping of bone and other bone related tissue in various orthopedic procedures. Typical procedures include, total-knee, uni-compartmental knee, hip, shoulder, ankle and orthopedic trauma procedures. The intended part of the body will be the areas associated with the above procedures. These products will be used in a fully equipped OR suite by surgeons.

Stryker Instruments Div. of Stryker

🏥 Medical Devices Class I - Dangerous

During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.

Mar 19, 2019 Implants & Prosthetics Nationwide View Details →

Valentine's Day stackable mugs

Lynns Concepts Ltd., of Hong Kong

🏠 Consumer Products Class I - Dangerous

The mugs were mislabeled as microwave safe. If microwaved, the metallic print on the mug can spark, posing a fire hazard.

May 1, 2019 Other Consumer Products Nationwide View Details →

All models of Kids II Rocking Sleepers

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

Infant fatalities have occurred in the Rocking Sleepers, after the infants rolled from their back to their stomach while unrestrained, or under other circumstances.

Apr 26, 2019 Furniture Nationwide View Details →

Ruggable shag area rugs

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The rug's shag cover fails to meet the federal flammability standard for carpets and rugs, posing a fire hazard.

Apr 25, 2019 Other Consumer Products Nationwide View Details →

Pain Relief Cream with Lidocaine

TriDerma, of Corona, Calif.

🏠 Consumer Products Class II - Moderate

The packaging is not child resistant as required by the Poison Prevention Packaging Act. The pain relieving cream contains lidocaine, posing a risk of poisoning to young children if they put it on their skin or ingest it.

Apr 25, 2019 Other Consumer Products Nationwide View Details →

Vitodens boilers

Viessmann Werke GmbH & Co KG, of Germany

🏠 Consumer Products Class II - Moderate

The boiler heat exchanger back plate can corrode and leak flue gases, allowing the boiler to emit excessive amounts of carbon monoxide, posing a CO poisoning hazard to consumers.

Apr 25, 2019 Other Consumer Products Nationwide View Details →