🔍 RecallPedia

All Recalls

95,094 total recalls in our database

Medical Devices

Consumer Products

Glimepiride, USP, 2 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0488-30; b) 90-count bottle, NDC 61919-0448-90 Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Ropinirole, USP, 1 mg Tablets, Rx Only, Packaged as a 30-count bottle, NDC 72189-0364-30; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60.

Ascend Laboratories

💊 Drugs Class I - Dangerous

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Mar 14, 2023 Prescription Drugs Nationwide View Details →

Simvastatin, USP, 10 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0688-30 b) 90-count bottle, NDC61919-0688-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Finasteride, USP, 5 mg Tablets, Rx Only, Packaged as a 90-count bottle, NDC 61919-0733-90; Packaged and Distributed By: Direct Rx

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only, 3801 Mojave Ct. Suite 101, Columbia, MO 65202, NDC 71170-950-25

Apollo Care

💊 Drugs Class I - Dangerous

Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Feb 8, 2023 Prescription Drugs View Details →

Montelukast Sodium Tablets, USP, 10 mg Tablets, Rx Only, Packaged as: a) 30-count bottle, NDC 61919-0009-30; b) 90-count bottle, NDC 61919-0009-90; Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.

Ascend Laboratories

💊 Drugs Class I - Dangerous

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Mar 14, 2023 Prescription Drugs Nationwide View Details →

Simvastatin, USP, 20 mg Tablets, Rx Only, Packaged as a a) 30-count bottle, NDC 61919-0446-30 b) 90-count bottle, NDC 61919-0446-90, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534

Direct Rx

💊 Drugs Class I - Dangerous

cGMP deviations

Mar 13, 2023 Prescription Drugs Nationwide View Details →

Instructions for Use for the following Leksell Stereotactic System and Leksell Neurosurgical Instruments: (1) Part #A2800-26, Backlund Catheter Insertion Needle Kit III; (2) Part #A2800-15, Backlund Catheter Insertion Needle Kit I; (3) Part #A2600-01, Backlund Haematoma Evacuator Kit; (4) Part #A2200-01, Salcman Twist Drill Kit I; (5) Part #907801, Insertion Cannula Kit; (6) Part #50398-01, Catheter Inserter Needle 1,5; (7) Part #307165, Insertion Cannula 190 MM; (8) Part #60377-02, Twist Drill 3.2 MM; (9) Part #60377-01, Twist Drill 2.1 MM; (10) Part #50376-01, Salcman Twist Drill 2.1/3.2; (11) Part #14001050, Catheter Inserter Needle 2,6; and (12) Part #1002248, Frame G w Straight/Curved Front.

Elekta Instrument AB

🏥 Medical Devices Class I - Dangerous

The incorrect IFU was distributed with the devices.

Mar 1, 2023 Surgical Instruments Nationwide View Details →

ARTIS pheno systems with a Siemens Healthineers table or a Trumpf/ MAQUET table-A Fluoroscopic X-Ray system. Material # 10849000.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

In the event of any unintended table movement, the system may not detect the incorrect direction, could lead to the injury of a patient, staff member, operator, or equipment.

Feb 2, 2023 Other Medical Devices Nationwide View Details →

ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0000880311R

Instrumentation Laboratory

🏥 Medical Devices Class I - Dangerous

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Feb 3, 2023 Diagnostic Equipment Nationwide View Details →

PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

Entopsis

🏥 Medical Devices Class I - Dangerous

Presence of misleading label statements on the product label.

Feb 21, 2023 Infusion Pumps Nationwide View Details →

ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory, for coagulation and/or fibrinolysis testing. Part Number: 0001000311

Instrumentation Laboratory

🏥 Medical Devices Class I - Dangerous

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Feb 3, 2023 Diagnostic Equipment Nationwide View Details →

Neodent GM X 6mm Engaging Titanium Base, REF: 9007162

Preat

🏥 Medical Devices Class I - Dangerous

Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to abutment/screw fracture, which could result in the abutment/screw/crown being ingested by the patient.

Feb 21, 2023 Other Medical Devices Nationwide View Details →

PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

Entopsis

🏥 Medical Devices Class I - Dangerous

Presence of misleading label statements on the product label.

Feb 21, 2023 Infusion Pumps Nationwide View Details →

Automated Peritoneal Dialysis System. Used for automatic control of dialysis solution exchanges.

Baxter Healthcare

🏥 Medical Devices Class I - Dangerous

The electrical safety testing was not properly performed on the impacted devices and additional testing is required

Feb 22, 2023 Other Medical Devices View Details →

DDU-100 Lifeline Automated External Defibrillator (AED)-Indicated for use on victims of sudden cardiac arrest

Defibtech

🏥 Medical Devices Class I - Dangerous

A component of a sub-assembly used in the affected AEDs had not undergone durability and reliability testing, and if a malfunction occurs, therefore the device could fail to deliver therapy.

Feb 14, 2023 Other Medical Devices Nationwide View Details →

PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

Entopsis

🏥 Medical Devices Class I - Dangerous

Presence of misleading label statements on the product label.

Feb 21, 2023 Other Medical Devices Nationwide View Details →

Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305

Fujifilm Irvine Scientific

🏥 Medical Devices Class I - Dangerous

Due to the detection of oil toxicity in several lots of Oil for Embryo Culture products.

Jan 16, 2023 Other Medical Devices Nationwide View Details →