🔍 RecallPedia

All Recalls

95,050 total recalls in our database

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

Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-C ELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

🏥 Medical Devices Class I - Dangerous

Updates to the Instructions for Use.

Feb 25, 2019 Implants & Prosthetics Nationwide View Details →

Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Catalog Number GTCFS-65-1-JUG-CELECT-PT Product Usage: The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

🏥 Medical Devices Class I - Dangerous

Updates to the Instructions for Use.

Feb 25, 2019 Implants & Prosthetics Nationwide View Details →

Gentrix Surgical Matrix Thick, 20 x 30cm, Catalog Number PSMT2030, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

ACell

🏥 Medical Devices Class I - Dangerous

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Feb 14, 2019 Implants & Prosthetics Nationwide View Details →

Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as: CH16/40CM and CH14/40CM Product Usage: Urinary Catheters are sterile disposable devices intended to provide an intermittent pathway for drainage of fluids from the bladder. They are intended to be inserted intermittently through the urethra and up to the bladder enabling urine to drain. They are designed for short-term, intermittent transient use only and are not intended to be left in situ (there is no balloon on the tip to allow the catheter to be retained within the bladder). They are intended for single use only. They are intended to be removed once the bladder is fully drained. The goal of intermittent catheterization using Urology Catheters is to completely empty the bladder and prevent Urinary Tract Infections (UTIs).

ConvaTec

🏥 Medical Devices Class I - Dangerous

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Jan 9, 2019 Surgical Instruments Nationwide View Details →

CTL Medical Hex Driver, 1/4" Square QC, 4.0 Ratcheting Ref 015.7050

CTL Medical

🏥 Medical Devices Class I - Dangerous

the anti-toggle ring of the hex driver may separate from the driver shaft. If this occurs during surgery, the anti-toggle ring can be pressed into the pedicle screw head and cause separation of the screw from the housing upon tightening. if the anti-toggle ring remains in the pedicle crew head and can interfere with final tightening of the pedicle screw construct. this can lead to failure of the set crew and relies of the rod from the construct.

Jul 5, 2018 Infusion Pumps View Details →

Fructosamine Control 3, FR2996 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Randox Laboratories

🏥 Medical Devices Class I - Dangerous

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Dec 3, 2018 Other Medical Devices View Details →

Gentrix Surgical Matrix Thick, 30 x 40cm, Catalog Number PSMT3040, Lot 013948 - Product Usage: Gentrix Surgical Matrix Thick is intended for implantation to reinforce soft tissue where weakness exists in patients requiring gastroenterological or plastic and reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.

ACell

🏥 Medical Devices Class I - Dangerous

The devices were released from a lot for which one sample failed to meet the company' s tensile strength specification for lot release.

Feb 14, 2019 Implants & Prosthetics Nationwide View Details →

Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray CH05/40CM and xray CH08/40CM Product Usage: Duodenal and Stomach Gastroenterology Tubes are sterile disposable devices which may be inserted through the nose or mouth via the esophagus into the stomach or duodenum to assist in the drainage of gastric contents, decompression of the stomach or duodenum, or for obtaining a specimen of gastric contents. The device is intended to administer medication or fluids, and enteral feeding.

ConvaTec

🏥 Medical Devices Class I - Dangerous

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Jan 9, 2019 Other Medical Devices Nationwide View Details →

Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach, Catalog Number IGTCFS-65-1-UNl-TULIP Product Usage: The Gunther Tulip Filter is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations:(1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated; (2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

🏥 Medical Devices Class I - Dangerous

Updates to the Instructions for Use.

Feb 25, 2019 Implants & Prosthetics Nationwide View Details →

Fructosamine Calibrator, FR2993 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Randox Laboratories

🏥 Medical Devices Class I - Dangerous

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Dec 3, 2018 Other Medical Devices View Details →

aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended for multiple use.

AAP Implantate Ag

🏥 Medical Devices Class I - Dangerous

There is the potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate.

Jan 11, 2019 Implants & Prosthetics Nationwide View Details →

Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Catalog Number IGTCFS-65-1-FEM-TU LIP Product Usage: The Gunther Tulip Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: (1) Pulmonary thromboembolism when anticoagulant therapy is contraindicated;(2) Failure of anticoagulant therapy in thromboembolic diseases; (3) Emergency treatment following massive PE where anticipated benefits of conventional therapy are reduced; and (4) Chronic, recurrent PE where anticoagulant therapy has failed or is contraindicated. The Filter implant may be retrieved if clinically indicated. The product is intended for percutaneous placement via a femoral or jugular vein for filtration of inferior vena cava (IVC) blood to prevent PE.

Cook Medical Incorporated

🏥 Medical Devices Class I - Dangerous

Updates to the Instructions for Use.

Feb 25, 2019 Implants & Prosthetics Nationwide View Details →

Fructosamine Control 1, FR2994 This product is intended for in vitro use in the calibration of the Randox Liquid Fructosamine assay on clinical chemistry systems.

Randox Laboratories

🏥 Medical Devices Class I - Dangerous

The firm is conducting a Device Modification for Fructosamine Calibrator, Fructosamine Control 1 and Control 3 for the lots specified. The assigned value of Fructosamine in this calibrator and controls has now been re-assigned by a decrease of 25%.

Dec 3, 2018 Other Medical Devices View Details →

Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

Covidien, PLC

🏥 Medical Devices Class I - Dangerous

Potential for the sterile packaging to be compromised

Feb 15, 2019 Surgical Instruments Nationwide View Details →

FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow and blood clots without blocking the suction device, using a combination of suctioning and filtering.

ConvaTec

🏥 Medical Devices Class I - Dangerous

An internal assessment of packaging confirmed the potential for a breach in the sterile barrier.

Jan 9, 2019 Implants & Prosthetics Nationwide View Details →

Dimension Vista 1500, Analyzer, chemistry Model no. 10444801

Siemens Healthcare Diagnostics

🏥 Medical Devices Class I - Dangerous

When the Millipore Water Purification Module Progard Pretreatment Packs are used with Dimension Vista Triglyceride assay, patient and QC triglyceride results may be erroneously elevated as a result of contamination.

Dec 12, 2018 Other Medical Devices Nationwide View Details →

PET Plates Coated Film-MONOMEDBV2S2- Radiographic Film REF: XJUB8, XJM73, XJUDD, XJM85, EKLYZ. Product Usage: Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities.

Agfa N.V.

🏥 Medical Devices Class I - Dangerous

Due to an inhomogeneous coating solution, pinholes can become visible in even dark images. Visibility of the pinholes varies as material from this coating run shows pinholes in different frequencies and intensities

Jan 25, 2019 Other Medical Devices Nationwide View Details →