Recall

All recalls8,521 total

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NORTERA FOODS USA — Wegmans brand Frozen Cut Green Beans; 16oz bags

Product may contain foreign object that appears to be of rodent origin.

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Permobil Inc — Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031, Model version 3

This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,

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Magellan Diagnostics, Inc. — The LeadCare¿ II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare¿ II Test Kit is provided with the fol

Calibration Buttons being used in the kitting process were incorrectly labeled as Lot 2323M for lot 2333M. The use of mislabeled calibration Button with Lot #2333 can lead to delayed or erroneous high or erroneous low results.

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STRATASYS LTD — TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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STRATASYS LTD — TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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STRATASYS LTD — TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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STRATASYS LTD — TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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STRATASYS LTD — TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances

Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 3M15, Model Numbers: 722064, 722222 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 3M12, Model Numbers: 722063, 722221 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 7B20/15, Model Numbers: 722068, 722226 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Philips Azurion 5M12, Model Numbers: 722227 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 with the Roadmap Pro Software key

During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the footswitch pedal without generating an Xray image). The pedal tap may cause a dark image with the next fluoroscopy run.

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Lunds Mitchell Rd LLC — Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424

Korean Shrimp Salad may be mislabeled as Grilled Chicken Caesar Salad: Undeclared Shellfish (shrimp), Tree nuts (Cashew), Soybeans, and Sesame.

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NeuroSync, Inc. — NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a

Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or serviceable as of August 31, 2023.

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NOXBOX LTD — NOxBOXi Nitric Oxide Delivery System

Replacement of the internal Sample Pump due to high failure rates.

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Miach Orthopaedics — BEAR Implant (Bridge-Enhanced ACL Restoration); Model/Catalog: 1000;

The field action was initiated in February of 2023 and was limited to the affected lot from sales force trunk stock only.

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SUREPULSE MEDICAL LTD — Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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SUREPULSE MEDICAL LTD — Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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SUREPULSE MEDICAL LTD — Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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SUREPULSE MEDICAL LTD — Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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SUREPULSE MEDICAL LTD — Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor

Retroactively reported; Labeling contains incorrect sizing guide for Cap, a component of the heart rate monitor.

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Foundation Medicine, Inc. — FoundationOne CDx (F1CDx), RAL-0003 version 31.0

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

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Foundation Medicine, Inc. — FoundationOne Liquid CDx (F1LCDx), TECH-0009 version 6.0

Reports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of the issue occurrence.

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Eclectic Institute Inc — Eclectic Herb Vitamin Herb Blend vita biotic dietary supplement, 750mg, 150 capsules per plastic bottle, UPC 0 23363 52002 2. Eclectic Institute, Inc. 755 NE 6th Street Gresha

Product's ingredients names such as Oregon Grape, Cayenne Root, and Ginger Fruit and their quantities were not listed correctly in the Supplement Facts panel.

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Abiomed, Inc. — Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impel

Retrospective submission for following issues identified: 1. Alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing were identified in certain AIC consoles. 2. There is improper alignment between the purge cassette and the motor drive in the AIC. This can result in a piston block event and lead to the inability to complete priming of the purge system, requiring the user to switch to backup AIC console.

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CPSC, Trek Bicycle Corp. Announce Recall of Road Bikes and Handlebar Stems

The bolts on these bikes' handlebar stems can break, resulting in the handlebars detaching from the bike and causing riders to lose control and crash.

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CPSC, Halpern Import Co. Announce Recall of Cigarette Lighters

These lighters can burn with a high flame and can fail to extinguish, presenting fire and burn hazards.

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CPSC, Rainbow Play Systems Inc. Announce Recall of Play Sets to Replace Swing Chains

The chains can break while children are swinging and cause the swing seats to fall to the ground. Children can suffer injuries from falling to the ground while swinging.

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