🔍 RecallPedia

All Recalls

95,025 total recalls in our database

🍎
28,983
Food
 💊
17,685
Drugs
 🏥
38,779
Medical Devices
 🏠
9,578
Consumer Products

Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC: 63629-8392-09, barcode 083929152151; b) 60-count bottles, NDC: 63629-8392-03, barcode 083923152614; c) 90-count bottles, NDC:63629-8392-04, barcode 083924152614, Lannett Company Inc; Rx only, Packaged by Bryant Ranch Prepack, Burbank, CA 91504.

Bryant Ranch Prepack, Inc.

💊 Drugs Class I - Dangerous

Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on the label

Sep 28, 2021 Prescription Drugs Nationwide View Details →

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America

🏥 Medical Devices Class I - Dangerous

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

May 1, 2021 Other Medical Devices Nationwide View Details →

Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.

Medtronic Neuromodulation

🏥 Medical Devices Class I - Dangerous

The wireless rechargers (WR; WR9200 and WR9220; included in the Recharger Kits) become unresponsive if the charging steps, indicated in the Recharger Patient User Guide, are not followed.

Nov 4, 2021 Implants & Prosthetics Nationwide View Details →

Artis Q.zen ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848354

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Oct 20, 2021 Diagnostic Equipment Nationwide View Details →

Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETCF2828C49EE STENT GRAFT ETCF2828C49EE ENDUR II CUFF ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETUF2514C102EE STENT GRAFT ETUF2514C102EE ENDUR II AUI ETBF2313C124EE STENT GRAFT ETBF2313C124EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2516C166EE STENT GRAFT ETBF2516C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2813C166EE STENT GRAFT ETBF2813C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2816C166EE STENT GRAFT ETBF2816C166EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETBF2516C145EE STENT GRAFT ETBF2516C145EE ENDUR II BIF ETUF2514C102E STENT GRAFT ETUF2514C102E ENDUR II AUI ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETTF2828C70EE STENT GRAFT ETTF2828C70EE ENDUR II TUBE ETCF2525C49E STENT GRAFT ETCF2525C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETCF2828C49E STENT GRAFT ETCF2828C49E ENDUR II AOEXT ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETUF2814C102E STENT GRAFT ETUF2814C102E ENDUR II AUI ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETTF2525C70EE STENT GRAFT ETTF2525C70EE ENDUR II TUBE ETBF2313C166EE STENT GRAFT ETBF2313C166EE ENDUR II BIF ETBF2513C124EE STENT GRAFT ETBF2513C124EE ENDUR II BIF ET

Medtronic Vascular

🏥 Medical Devices Class I - Dangerous

Due to, during stent graft deployment, the spindle may detach from the distal end of the spindle hypotube.

Oct 15, 2021 Implants & Prosthetics Nationwide View Details →

HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.

Instrumentation Laboratory

🏥 Medical Devices Class I - Dangerous

The firm has received customer reports of performance issues with the affected lot, including increased imprecision, out of range quality controls, and prolonged sample results. If quality controls are not performed or do not pass for each vial of reagent, there is a potential risk of reporting an erroneous result.

Oct 13, 2021 Diagnostic Equipment Nationwide View Details →

Artis Q floor with software VD12- angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848280

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Oct 20, 2021 Diagnostic Equipment Nationwide View Details →

SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

software syngo.CT VB20 in the installed base, with or without syngo.CT software versions VB20_SP1, SP2, SP3, or SP4, may result in workflow interruptions resulting in the delay in diagnosis, the necessity for patient rescans, and/or the need for additional contrast media may occur

Aug 30, 2021 Other Medical Devices Nationwide View Details →

Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

The Binding Site Group

🏥 Medical Devices Class I - Dangerous

Due to calibration curves producing a higher activity than routinely expected and that there may be a decrease in separation between calibrator point 5 and calibrator point 6, which can be exacerbated with calibrator 6 activity reaches the optical ceiling of the SPA+ analyzer.

Oct 15, 2021 Other Medical Devices View Details →

The da Vinci Xi and X surgical systems (IS4000 and IS4200) each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The Patient Cart is the operative component of the system and its primary function is to support the instrument arms and camera arm. The X/Xi Instrument Arm Drape is intended to be used with the instrument arms of the PC as a sterile barrier during clinical procedures, and makes the instrument arms sterile and suitable for surgery. X/Xi Instrument Arm Drapes are sterile unless the package is opened or damaged, and are indicated for a single use. The drapes are placed onto the instrument arms by two users (one sterile and one non-sterile)in tandem, with the non-sterile user leading the placement via drape cuff pockets.

Intuitive Surgical

🏥 Medical Devices Class I - Dangerous

Incorrect expiration date on its package labeling (shipper box and inner carton label).

Sep 21, 2021 Surgical Instruments Nationwide View Details →

Artis Q biplane with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848282

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Oct 20, 2021 Diagnostic Equipment Nationwide View Details →

Artis zee floor with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10094135

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Oct 20, 2021 Diagnostic Equipment Nationwide View Details →

Artis zee ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number:10094137

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If SID (source-to-image distance) lift movement is activated and x-ray shall be released simultaneously; x-ray is not possible and the message No x-ray, try again is displayed, may result in a short delay in procedure

Oct 20, 2021 Diagnostic Equipment Nationwide View Details →

Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.

Philips North America

🏥 Medical Devices Class I - Dangerous

Significant wear of the Monitor Bracket Assembly shaft may go unrecognized could lead to the Monitor Bracket Assembly detaching from the Suspension Arm, and resulting in injury to patient, operator, bystander, or service person located in the path of a falling part

May 1, 2021 Other Medical Devices Nationwide View Details →

ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89

Abbott Laboratories

🏥 Medical Devices Class I - Dangerous

Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash buffer containers, missing QC flags, signal spikes, abnormal optics reads, and incorrect sample aspiration. The issues may lead to inaccurate results with an unknown bias direction and magnitude for assays measuring cardiac, metabolic (including diabetes), toxicology, prenatal, therapeutic drug monitoring, infectious disease, oncology, hepatic, pancreatic, hematological, endocrinologic, inflammatory analytes.

Sep 29, 2021 Other Medical Devices Nationwide View Details →