Archive
831 recalls were announced in August 2019.
Of the 831 recalls this month scored against our rubric, 2% are Critical, 30% are Severe.
Which agencies issued them
RXQ Compounding LLC is recalling Sodium Bicarbonate 8.4% Injection due to a lack of assurance of sterility. The product is distributed nationwide.
RXQ Compounding LLC is recalling Pyridoxine (MDV) 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Lidocaine HCL 2% Injection Solution because the product lacks assurance of sterility. The recall covers all lots within their expiry dates.
RXQ Compounding LLC is recalling Turbo Caine 2.5 syringes because the FDA determined there is a lack of assurance of sterility.
RXQ Compounding LLC is recalling Procaine HCL 8% Injectable due to a lack of assurance of sterility. The recall covers all lots within expiry distributed nationwide.
RXQ Compounding LLC is recalling Methylcobalamin 10 mg/mL injectable vials because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Epinephrine 1:1000 Injection Solution syringes because the company cannot ensure the product is sterile.
RXQ Compounding LLC is recalling MIC (Methionine/Inositol/Choline Chloride) 25/50/50 mg/mL Injection due to a lack of assurance of sterility.
RXQ Compounding LLC is recalling Procaine HCL 20 mg/mL Injectable Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Ketamine 50 mg/mL injection solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Methylcobalamin 1 mg/mL Injectable Solution because the product lacks assurance of sterility.
RXQ Compounding LLC is recalling Inositol/Choline B12:B6 injection solution because there is a lack of assurance of sterility.
RXQ Compounding LLC is recalling magnesium, calcium, and zinc vials due to a lack of assurance of sterility. The products were distributed nationwide.
RXQ Compounding LLC is recalling Glutathione 200mg/ml Injection Solution because the product lacks assurance of sterility. All lots within expiry are affected nationwide.
Comet Technologies is recalling 93 YXLON Cougar Cabinet X-Ray Systems because the door interlocks fail to meet federal performance standards for power disconnection.
MED-EL is recalling PULSARci100 Cochlear Implants because they failed helium-fine leak tests. Affected devices were distributed in the US and several international countries.
Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.
ROi is recalling 312 custom surgical packs containing Stryker Pneumosure tubesets due to a risk of tube detachment and gas leakage.
RXQ Compounding LLC is recalling Niacinamide 100mg/mL vials because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Centurion Medical Products Corporation is recalling 220 Circumcision Tray kits (Lot # 2019052190) because the sterile packaging may be compromised, posing a risk of infection during newborn procedures.
Gk Photonics Inc is recalling the Atom Laser Projection Series because the provided remote interlock dongle does not fully comply with FDA manual reset requirements, posing a risk of high-power laser exposure.
Hycor Biomedical is recalling HYTEC 288 System and RF assay kits because high IgG levels may cause false positive results, leading to incorrect rheumatoid diagnoses.
Medline Industries is recalling endoscopic cleaning brushes because they may detach during use, potentially leaving parts inside endoscopes.
CH Guenther & Sons, Inc. is recalling Williams Ingredients Hot BBQ Snack Seasoning because the product may be contaminated with Salmonella.
Centurion Medical Products Corporation is recalling 1,224 LVAD Dressing System kits because the sterile packaging may be compromised, posing a risk of infection.
Centurion Medical Products is recalling 400 sterile fluoro SSP trays because the sterile packaging may be compromised. The kits are used for arthrogram injection and aspiration.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints of leaks, suction issues, and failure to obtain tissue samples.
Gk Photonics is recalling the Maxim Laser Projection Series because the provided remote interlock dongle may not fully comply with FDA safety requirements, potentially exposing users to high-power laser radiation.
CH Guenther & Sons, Inc. is recalling Great Value Mild Taco Seasoning because it contains cumin potentially contaminated with Salmonella.
Centurion Medical Products is recalling Universal Block Tray kits because sterile packaging may be compromised, posing a risk of infection during regional anesthesia.
Centurion Medical Products is recalling sterile Graves vaginal speculums because the sterile packaging may be compromised, potentially exposing patients to infection.
Ortho Clinical Diagnostics is recalling 89 VITROS 5600 clinical chemistry analyzers worldwide due to a software anomaly that may cause unsuccessful calibrations.
Northfork Bison Distributions Inc. is voluntarily recalling bison burgers and ground bison due to potential contamination by E. coli O121 and O103.
RXQ Compounding LLC is recalling Fentanyl and Bupivacaine syringes nationwide due to a lack of assurance of sterility.
Milkweed & Monarch, LLC is recalling specific lots of Ginger Spice, Sandia Rose, and Honey Lavender herbal teas due to potential Salmonella contamination.
CH Guenther & Sons is recalling Winco Foods Taco Seasoning Mild because the cumin ingredient may be contaminated with Salmonella.
CH Guenther & Sons, Inc. is recalling HEB Taco Seasoning Mix because the cumin ingredient may be contaminated with Salmonella.
Milkweed & Monarch, LLC is recalling specific lots of Ginger Spice, Sandia Rose, and Honey Lavender herbal teas due to potential Salmonella contamination.
Abbott is recalling 943 Alinity ci-series System Control Modules because software may fail to detect issues in specific electrolyte assays.
ROi Consolidated Service Center is recalling 261 custom surgical packs containing Stryker Pneumosure tubesets that may detach from the cassette, potentially causing gas leaks.
St Jude Medical is recalling 15 Ellipse DR cardioverter defibrillators due to damaged aluminum wires that may prevent high-voltage therapy delivery.
Centurion Medical Products is recalling 48 SNAG FREE SUTURE TRAY kits because sterile packaging may be compromised, posing a risk of infection.
Olympus is recalling MAJ-209 Single Use Suction Valves because they may come apart or remain stuck inside endoscopes.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction problems, and failure to obtain tissue samples.
Integra LifeSciences is recalling 125 units of Codman ISOCOOL Bipolar Forceps because inadequate insulation coating may prevent proper tissue coagulation during surgery.
Gk Photonics Inc is recalling the Burstberry Laser Projection Series because the provided remote interlock dongle fails to meet FDA safety requirements, posing a risk of high-power laser radiation exposure.
RXQ Compounding LLC is voluntarily recalling Ascorbic Acid 500 MG/ML Injection due to crystallization. The recall covers all lots within expiry distributed nationwide.
MED-EL is recalling seven Mi1000 CONCERTO cochlear implant devices because they were distributed despite failing helium-fine leak tests. The devices are intended for severely to profoundly hearing impaired individuals.
BMW is recalling two 2020 M340i vehicles because improper welding may allow the rear center headrest to fold during a crash, increasing injury risk.
Gk Photonics is recalling the Spectrum Laser Projection Series because the included remote interlock dongle may fail to prevent high-power laser radiation exposure.
Siemens is recalling two Lantis 8.3 Commander units due to a Microsoft Windows Remote Desktop Protocol vulnerability.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Centurion Medical Products Corporation is recalling 3,250 Daily Driveline Kits because the sterile packaging may be compromised, posing a risk of infection.
Milkweed & Monarch, LLC is recalling specific lots of Ginger Spice, Sandia Rose, and Honey Lavender herbal teas due to potential Salmonella contamination.
Centurion Medical Products is recalling 120 Neonatal PICC Insertion Trays because the sterile packaging may be compromised, posing a risk of infection.
SenTec AG is recalling 3 sets of Membrane Changer Sets because there is a 5% chance of insufficient electrolyte application during sensor changes.
SenTec AG is recalling Membrane Changer Inserts due to a 5% chance of missing or reduced electrolyte application during sensor changes.
MED-EL is recalling 10 SONATAti100 cochlear implants because they failed helium-fine leak tests. The devices were distributed despite not meeting specifications.
Biomet 3i is recalling 3 units of Bellatek Tin Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
Biomet 3i is recalling 6 units of Certain Bellatek Titanium Abutments because a manufacturing defect causes the screw head to seat too deep without a positive stop.
MicroAire is recalling 103 SmartRelease Endoscopic Carpal Tunnel Release Handpieces because the blade may fail to retract when tightened.
Centurion Medical Products is recalling 1,900 Driveline Management Tray Kits because sterile packaging may be compromised, posing a risk of infection.
Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products GLU Slides due to potentially biased results.
Comet Technologies is recalling 77 YXLON Cheetah cabinet X-Ray systems because the door interlock fails to meet federal performance standards for power disconnection.
Bard Peripheral Vascular Inc is recalling 239 units of EnCor Breast Biopsy Probes due to reports of leaks, suction issues, and failure to obtain tissue samples.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Herbal Doctor Remedies is recalling Lung Tonic EX Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Centurion Medical Products is recalling Laceration Tray Kits because sterile packaging may be compromised, posing a risk of infection.
Bard Peripheral Vascular Inc is recalling EnCor Breast Biopsy Probes due to increased complaints about leaks, suction issues, and failure to obtain samples.
Gk Photonics is recalling Logolas Laser Projection Series units because the remote interlock dongle may not fully comply with FDA safety requirements, posing a risk of high-power laser exposure.
SenTec AG is recalling Neonatal Starter Sets due to a 5% chance of missing or reduced electrolyte application during membrane changes.
SenTec AG is recalling Standard Starter Sets due to a risk of missing or reduced electrolyte application during the membrane change procedure.
RXQ Compounding LLC is recalling hydromorphone syringes because the company cannot ensure the product is sterile.
RXQ Compounding LLC is recalling Hydrogen Peroxide 3% Injectable PFV because the product lacks assurance of sterility. The recall covers all lots within expiry distributed nationwide.
Centurion Medical Products Corporation is recalling 168 Circumcision Tray kits because sterile packaging may be compromised. The kits are used for newborn circumcision procedures.
SenTec AG is recalling 198 Membrane Changer units because a defect may result in insufficient electrolyte application during sensor changes.
FDA is recalling Shirakiku Fish Cake because it may contain undeclared egg, milk, and shellfish allergens in 20,101 packages distributed across multiple states.
Herbal Doctor Remedies is recalling Vertigo Off Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
ASTRA, LLC is recalling one Lidar System for Erosion Flume Application due to incorrect labeling of a Class 1 laser product.
Herbal Doctor Remedies is recalling Worm Off 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Pain Stopper 500 mg capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Thyro-H 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Baby Saver Capsules because they were manufactured outside of required Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling 30 VITROS 250AT Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Geistlich Pharma North America is recalling Bio-Oss Pen applicators because a visible piece of green plastic was found on the outer barrel when unscrewing the cap.
Unipharma is recalling DrKids Children's Allergy Relief Diphenhydramine vials due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
RXQ Compounding LLC is recalling Ascorbic Acid 400 MG/ML Injection Solution because of crystallization. The recall covers all lots within expiry distributed nationwide.
Herbal Doctor Remedies is recalling Asma Aid because it was manufactured outside of required Good Manufacturing Practices. The product was distributed nationwide and in Brazil.
Unipharma is recalling CVS Health Children's Allergy Relief Liquid Medication due to potential contamination with B. cepacia bacteria. The recall is a precautionary measure.
Herbal Doctor Remedies is recalling Cardia Forte 500 mg capsules because they were manufactured outside of current Good Manufacturing Practices controls.
Philips is recalling 116 CT systems because cardiac images may be incorrectly labeled as having phase tolerance applied when it was not.
Ortho Clinical Diagnostics is recalling 825 VITROS 4600 Chemistry Systems worldwide due to a software anomaly that may cause unsuccessful calibrations.
Brill, Inc. is recalling 402 cases of frozen, unbaked lemon poppy seed muffins due to potential contamination with small pieces of plastic.
Ortho Clinical Diagnostics is recalling nine VITROS 4600 Chemistry Systems due to a software anomaly that may cause unsuccessful calibration.
Brill, Inc. is recalling 320 cases of frozen, unbaked Double Dutch Muffins due to potential contamination with small pieces of plastic.
Herbal Doctor Remedies is recalling Yeast Douche Powder because it was manufactured outside of required Good Manufacturing Practices controls.
Herbal Doctor Remedies is recalling Prostatin Capsules because they were manufactured outside of current Good Manufacturing Practice controls.
Herbal Doctor Remedies is recalling Dragon Pain Oil because it was manufactured outside of required Good Manufacturing Practices controls.
Ortho Clinical Diagnostics is recalling VITROS Chemistry Products Calibrator Kit 32 due to a software anomaly that may cause unsuccessful calibration.
Unipharma, LLC is recalling CVS Health Children's Nasal Saline Drops due to a precautionary measure regarding potential contamination with B. cepacia bacteria.
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