🔍 RecallPedia

All Recalls

95,025 total recalls in our database

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

FlexLab Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

Inpeco S.A.

🏥 Medical Devices Class I - Dangerous

The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.

Apr 7, 2020 Surgical Instruments View Details →

Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

Biomet

🏥 Medical Devices Class I - Dangerous

Potential presence of elevated endotoxin levels that exceed the specification limit

Apr 17, 2020 Implants & Prosthetics Nationwide View Details →

Guardian Connect App CSS7200 iOS and Guardian Connect Transmitter GST4C used on the iPhone, iPad and iPod Touch devices.

Medtronic

🏥 Medical Devices Class I - Dangerous

Customers using the firm's continuous glucose monitoring system application on an iPhone, iPad or iPod Touch with ios software version 12, 12.1, or 12,2 are likely to experience a shortened transmitter battery life (approximately 4-5 days instead of the normal 7 days or more) after a full charge.

May 20, 2019 Other Medical Devices Nationwide View Details →

Sprotte Needle, REF 32115130C w/ Intro 22 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

TELEFLEX MEDICAL

🏥 Medical Devices Class I - Dangerous

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

Oct 11, 2019 Diagnostic Equipment Nationwide View Details →

Optilite Optilite Rheumatoid Factor Kit, Ref: LK151.OPT.A, IVD, Rx Only, UDI: 05051700020015 (kit ea. containing four components)

The Binding Site Group

🏥 Medical Devices Class I - Dangerous

Assigned Rheumatoid Factor (RF) calibrator value for calibrator component included in kit used to aid in the diagnosis of rheumatoid arthritis over recovers by 7% in comparison to the reference material RF serum. This could result in reporting abnormal (false positive) results, which may lead to unnecessary additional serological testing and a delay in treatment.

Oct 7, 2019 Infusion Pumps Nationwide View Details →

Accelerator a3600 Automation System used with the following Modules: High Volume Storage(P/N FLX-270, FLX-271, FLX-276, FLX-282, FLX-283), HSQ Interface Module (P/N FLX-274), Aliquoter Module (P/N FLX-209), Rack Output Module ROM400 (P/N FLX-289), XN-9000 Interface Module (P/N FLX-290), Advia 2120 LAS Interface Module (P/N FLX-219), Vertical Transportation Module (P/N FLX -204), Rack Input Module (P/N FLX-214), AUWi System Interface Module (P/N FLX-286), Track To Rack Interface Module (P/N FLX-295) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

Inpeco S.A.

🏥 Medical Devices Class I - Dangerous

The sensors which activate the safety switches may be affected by delayed activation. In 1% of the cases, the response delay can be up to a maximum delay of 2 seconds, instead of 40ms expected by design.

Apr 7, 2020 Surgical Instruments View Details →

Aptio Automation System with Advia2120LAS Interface Module (P/N FLX-219-00, FLX-219-10), ImmunoCAP 1000 Interface Module (P/N FLX-226-01, FLX-226-10), or StaRRsed Interface Module (P/N FLX-268-00) - Product Usage: is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

Inpeco S.A.

🏥 Medical Devices Class I - Dangerous

The identified problem is an erroneous association between the carrier and the sample tube caused by a communication error between the firmware of the Interface Modules and the Automation software. This problem can occur only when one of these Interface Modules is put off-line after a carrier in their secondary lane is physically returned on the main track and then put back on-line when the carrier is used to transport another tube.

Apr 7, 2020 Surgical Instruments Nationwide View Details →

ArtisanTM 70 cm 2 x 8 Surgical Lead Kit, part number M365SC8216700. 2 x 8 Surgical Paddle Lead Kit: (1) One Paddle Lead (4); Four Suture Sleeves; (2) Lead Position Labels, left and right (Non-Sterile); (1) Device Registration Form/Temporary Patient Identification Card; (1) Manual - Product Usage: The surgical paddle leads function as a component of Boston Scientific s spinal cord stimulator (SCS) systems by delivering electrical stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in a inhibition of pain sensation.

Boston Scientific Neuromodulation

🏥 Medical Devices Class I - Dangerous

The firm is initiating a voluntary removal of certain spinal cord stimulation leads, lead extensions, adapters, and deep brain stimulation lead extensions due to the "use by date" displayed on the label which is later than the correct "use by date". No adverse health consequence is expected to occur from this issue.

Apr 24, 2019 Surgical Instruments View Details →

Sprotte Needle, REF 33115131B w/ Intro 20 G x 3.5", distributed by Teleflex Medical The SPROTTE lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection (including anesthesia) / withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/discography procedures.

TELEFLEX MEDICAL

🏥 Medical Devices Class I - Dangerous

Teleflex received the attached Medical Device Recall Notice from Pajunk Medical. Teleflex Medical is a distributor of Pajunk products. According to the notice, Pajunk internally identified a packaging problem that may affect certain batches of the SPROTTE lumbar puncture cannulas with introducer. Due to this problem Pajunk cannot guarantee the sterility of the affected batches.

Oct 11, 2019 Diagnostic Equipment Nationwide View Details →

ARTIS Pheno - Interventional Fluoroscopic X-Ray System Model: 10849000 - Product Usage: is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

If the C-arm leaves its intended travel path due to a fault within the drivetrain, movements may be impacted or impossible and the area of interest cannot be reached. In the event the C-arms movements are not possible, the system can only be returned to normal operation with the support of a field service engineer

Apr 22, 2020 Diagnostic Equipment Nationwide View Details →

ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.

Abbott Gmbh & Co. KG

🏥 Medical Devices Class I - Dangerous

Abbott identified that samples tested for ARCHITECT STAT High Sensitive Troponin I and STAT High Sensitivity Troponin I assays (LN 3P25 and LN 2R98) may show interaction when processed directly after the ARCHITECT iGentamicin (LN 1P31) assay and patient results might be impacted.

Apr 24, 2020 Diagnostic Equipment Nationwide View Details →

Willamette Valley Pie Company Raspberry Rhubarb Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87931 2. The label on a clamshell container is read in parts: "***HANDMADE All-Natural Raspberry Rhubarb Pie ***BAKED & READY TO EAT*** INGREDIENTS: Filling: Rhubarb, Organic Cane Sugar, Raspberries, Enriched Wheat Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Cinnamon. Crust: Enriched Wheat Flour (wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Organic Palm Oil, Water, Organic Cane Sugar, Sea Salt. Contains: WHEAT***". The label on a master CASE is read in parts: "***5" RASPBERRY/RHUBARB PIE ***BAKED RETAIL***6 units/case***"

Willamette Valley Pie Company

🍎 Food Class I - Dangerous

Raspberry Rhubarb Pie packages were recalled due to undeclared artificial almond. The actual product inside a clamshell package is Cherry Pie, which contains artificial almond extract, but it was mislabeled as Raspberry Rhubarb Pie. The Rhubarb Pie label does not declare artificial almond extract.

May 13, 2020 Produce View Details →

Willamette Valley Pie Company Cherry Pie, packaged in clamshells container, six containers per case. Each pie weighs 10 oz. and sold as individual pies to consumers. UPC: 0 22518 87916 9. The label on a clamshell container is read in parts: "***HANDMADE All-Natural Cherry Pie ***BAKED & READY TO EAT*** INGREDIENTS: Filling: Cherries, Organic Cane Sugar, Enriched Wheat Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Almond Extract (water, alcohol, oil of bitter almond), Cinnamon. Crust: Enriched Wheat Flour (wheat flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Organic Palm Oil, Water, Organic Cane Sugar, Sea Salt. Contains: WHEAT, TREE NUTS (Almond)***". The label on a master CASE is read in parts: "***5" CHERRY PIE ***BAKED RETAIL***6 units/case***".

Willamette Valley Pie Company

🍎 Food Class I - Dangerous

Cherry Pie packages were recalled due to being misbranded. The actual product inside clamshell package is Raspberry Rhubarb Pie, but it was mislabeled as Cherry Pie. Raspberry Rhubarb Pie does NOT contain artificial almond extract.

May 13, 2020 Bakery & Bread View Details →