Archive
446 recalls were announced in December 2021.
Of the 446 recalls this month scored against our rubric, 2% are Critical, 22% are Severe.
Which agencies issued them
Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.
Siemens SOMATOM Drive CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnosis and require additional patient scans. Approximately 75 units are affected nationwide.
Western/Scott Fetzer is recalling Digital VIPR devices (Model MNDR-600) due to battery rupture risk that could cause plastic shroud breakage and fume emission. The recall affects 4974 units distributed from May 2020 to August 2021.
Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.
Siemens SOMATOM Definition Flash CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnoses and require additional rescans and contrast media. This recall affects 121 units distributed nationwide.
Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.
Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.
Medtronic is recalling 511 Endurant II Stent Graft Systems because during deployment, the spindle may detach from the distal end of the spindle hypotube.
Clek is recalling specific Liing and Liingo infant child seats because a plastic canopy support part may break and detach, creating a choking hazard.
Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.
A ceiling-mounted component on Philips CT imaging equipment may detach due to wear. This poses a risk of injury to patients, operators, or staff in operating rooms.
Becton Dickinson is recalling BD Nexiva IV catheter systems because of a packaging breach that renders them non-sterile. The recall affects 155,840 devices distributed nationwide.
Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.
A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.
Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.
Clek is recalling specific Foonf and Fllo convertible child seats because loose foam pieces can pose a choking hazard to children.
King's Hawaiian Hawaiian Sweet Hamburger Buns may contain small plastic foreign material. Products on hold for quality inspection were accidentally released into commerce.
Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.
Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.
Medtronic is recalling 7 Cardioblate CryoFlex Surgical Ablation Consoles due to potential intermittent electrical connectivity loss between the console and probe.
Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.
The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.
Volkswagen Group of America is recalling 2022 Audi E-Tron GT vehicles because a loose retaining ring on air suspension struts may compromise handling and increase crash risk.
Medtronic is recalling the Wireless Recharger Model WR9200 used with RestoreUltra and RestoreSensor neurostimulator implants. The recharger becomes unresponsive if charging instructions from the user guide are not followed correctly.
Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.
A software issue in SOMATOM Definition AS CT scanners may cause workflow interruptions, leading to diagnostic delays and the need for patient rescans. The recall affects approximately 665 units distributed nationwide.
Philips Healthcare is recalling ProxiDiagnost N90 diagnostic X-ray systems that lack required FDA radiation warning labels. Some units nationwide were found missing the mandatory radiation safety labels and certification statements required by federal standards.
Three Siemens Artis Q.zen angiography systems may fail to fire X-rays when the source-to-image distance lift is activated simultaneously with X-ray commands. This causes a procedural delay.
Siemens is recalling 19 units of its Artis zee angiography system due to a software issue that may prevent x-ray activation under specific operating conditions, causing procedural delay.
Siemens is recalling Artis zee ceiling-mounted x-ray imaging systems equipped with VD12 software. A software issue may prevent x-ray delivery when the source-to-image distance lift is activated during procedures, resulting in procedural delays.
Ukrop's Homestyle Foods is recalling Garden Side Salad 6.95oz containers due to possible contamination with plastic fragments. The product was distributed to retail stores across six states.
Intuitive Surgical recalls 1,740 da Vinci Instrument Arm Drapes due to incorrect expiration dates on package labeling. The error may prevent accurate verification of sterility assurance dates.
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% w/w due to a defective container. The recall affects approximately 2,664 bottles distributed nationwide.
Teligent Pharma, Inc. is recalling Diclofenac Sodium Topical Solution USP 1.5% due to a defective container. The recall affects 5,400 units distributed nationwide.
Siemens Artis zee floor angiography systems may fail to release x-rays when the SID lift and x-ray functions are activated simultaneously, causing procedural delay. Three units are affected.
Siemens has recalled two Artis Q.zen angiography systems due to a software issue that may prevent x-ray imaging and delay procedures when SID lift and x-ray controls are activated simultaneously.
Siemens Artis zee biplane X-ray imaging systems may fail to release X-rays when the source-to-image distance lift is activated simultaneously, resulting in procedural delays.
Siemens Medical Solutions is recalling 15 Artis Q biplane diagnostic x-ray systems due to a software issue in the VD12-angiography subsystem. When source-to-image distance lift is activated simultaneously with x-ray release, the system fails to activate and displays an error message, causing procedural delay.
Empresas La Famosa, Inc. is recalling Mr. Special Jugo de Pina De Concentrado 46 oz cans due to swollen cans discovered during production. The recall affects 409 cases distributed in Puerto Rico.
Siemens Artis Q floor angiography systems may fail to produce x-ray when SID lift movement is activated during x-ray release, resulting in procedural delays. The system displays an error message.
Siemens is recalling 15 Artis Q.zen angiography systems that may fail to generate x-rays when the lift mechanism and x-ray release are activated simultaneously, potentially causing a procedural delay.
Ukrop's Homestyle Foods, LLC is recalling Mexican Side Salad 6.95oz. containers due to potential contamination with plastic fragments. Affected products were distributed to retail and distribution centers in six states.
Aurobindo Pharma USA Inc. is recalling Carvedilol 6.25 mg tablets nationwide due to failed impurities and degradation specifications. Affected containers bear Batch QG0619030-A with expiration date 11/2022.
Unichem Pharmaceuticals USA Inc is recalling Topiramate 50 mg tablets nationwide due to discoloration. The affected lot is ZTPM20044, expiring 09/30/2022.
Bryant Ranch Prepack is recalling Butalbital, APAP, Caffeine 50/325/40 mg tablets in multiple bottle sizes because the controlled substance classification "CIII" is missing from the label.
Bryant Ranch Prepack is recalling Butalbital, APAP, and Caffeine 50/325/40 mg tablets because the label is missing the controlled substance classification "CIII" required by law.
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