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Showing 7821–7840 of 11714 results

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Biofinity XR Toric 6-pack (CooperVision) – Axis Misalignment (2023)

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

FDAJan 26, 2023Nationwide• CooperVision, Inc.

Biofinity XR Toric Diagnostic Lens (CooperVision) – Axis Misalignment (2023)

Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity

FDAJan 26, 2023Nationwide• CooperVision, Inc.

Life2000 Ventilator (Baxter) – Desaturation Risk (2023)

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

High

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation

Life2000 Ventilator (Baxter) – Desaturation Risk (2023)

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation

Life2000 Ventilator PKG (Baxter) – Desaturation Risk (2023)

There is the potential for patient desaturation events to occur under certain scenarios when the Life2000 ventilation system is connected with an oxygen concentrator.

FDAJan 25, 2023Nationwide• Baxter Healthcare Corporation

Medivac Guardian Inserts (Stryker) – Blood Loss Estimate (2023)

Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.

FDAJan 25, 2023Nationwide• Stryker Corporation

TEMA Axle Small (Limacorporate) – Incorrect Component (2023)

Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

FDAJan 25, 2023TX• Limacorporate S.p.A Via Nazionale 52 Di San Daniele San Daniele Del Friuli Italy

Tri-Staple 2.0 Reload (Unknown) – Sled Vane Failure (2023)

Affected lots have the potential for a broken sled vane, which may cause the reload to misfire leading to non-functional staple line closure, transecting tissue without forming staples, and tissue hang-up. These conditions may be associated to a delay to treatment, unspecified infection, hemorrhage/blood loss/bleeding, failure to anastomose, peritonitis, sepsis, pneumothorax, tissue trauma, or death.

FDAJan 25, 2023Nationwide

First Response Pregnancy App (Church & Dwight) – Marketing Compliance (2023)

Church & Dwight First Response Pregnancy Kits was marketed with the Easy Read App without a new 510k. There is also a potential for Easy Read App to be unable to reads the test results (i.e., no results reported on the APP screen) or to misread the analog results shown on the pregnancy test stick and may lead to misinterpretation of false positive or false negative tests by the user.

FDAJan 25, 2023Nationwide• Church & Dwight Inc

Triton Canister Software (Stryker) – Blood Loss Estimate (2023)

Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or prolongation of postpartum hemorrhage (PPH), or require more aggressive treatment for PPH.

FDAJan 25, 2023Nationwide• Stryker Corporation

Outset Tablo (Outset Medical) – Conductivity Alarm (2023)

An observed trend of high conductivity dialysate alarms in a hemodialysis system as a result of introducing a software tool into the manufacturing process.

FDAJan 24, 2023Nationwide• Outset Medical, Inc.

Patient Side Cart (Intuitive Surgical) – Instrument Arm Maintenance (2023)

Preventative maintenance data was used to identify instrument Arms, part of surgical systems, that allow surgeons to perform surgical tasks, that may be at risk of insertion ballscrew failure, allowing for uncontrolled carriage movement along the insertion axis, which may cause tissue injury.

FDAJan 24, 2023Nationwide• Intuitive Surgical, Inc.

Alaris PC Unit (CareFusion) – Network Connection Failure (2023)

Infusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive new datasets and inability to transfer retrospective analytics data to connected systems. Users with interfaces to electronic medication record or admin discharge transfer, may be unable to receive/send data; infusions may need to be manually programmed

FDAJan 24, 2023AL, AK, AZ +47 more• CareFusion 303, Inc.

NovaStar TS Anti-Asphyxia Valve (Draeger) – Magnet Impact (2023)

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

FDAJan 23, 2023Nationwide• Draeger Medical, Inc.

NovaStar TS Standard Elbow (Draeger) – Magnet Impact (2023)

The magnets used in the swivel frame/tube set and the headgear clips might impact medical devices (implanted as well as not implanted) and metallic implants.

FDAJan 23, 2023Nationwide• Draeger Medical, Inc.

SciCan STATIS Dental Handpiece (Coltene) – Screw Connection Risk (2023)

Screw connection between the turbine head and the push button may loosen and fall off during the treatment, and increase the risk of swallowing or inhaling part of the turbines head or the push button

FDAJan 20, 2023Nationwide• Coltene Whaledent Inc

SenSight Connector Plug (Medtronic) – Use By Date (2023)

Medtronic is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.

FDAJan 20, 2023Nationwide• Medtronic Neuromodulation

Sprint 200 Stretcher (Linet) – Siderail Locking (2023)

Labeling being updated to assure user is securing the siderail to a locked position to prevent potential patient fall and injury.

FDAJan 18, 2023AL, CA, FL +11 more• Linet Spol. S.r.o. Zelevcice 5 Zelevcice Czech Republic

IntelliVue G7m Anesthesia Module (Philips) – Gas Measurement Interruption (2023)

The 866173 lntelliVue G7m Anesthesia Gas Modules could have a component issue that may trigger an interruption of the gas measurement. This issue concerns the G7m's sample gas pump which could stop working, producing a technical, INOP (inoperable) alarm. The pump may fail prematurely when there is friction caused by an abrasion. This recall is for an IMPORTANT PRODUCT NOTICE dated 1/18/23.

FDAJan 18, 2023Nationwide• Philips North America

Hand Sanitizer (Fisher) - CGMP Manufacturing Issue (2023)

CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.

Class IIModerate

FDAJan 17, 2023Nationwide• Fisher Scientific Co., LLC

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