November 15, 2023Medical DevicesFDA
Young Dental Manufacturing I, LLC recalls CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
Hazard: one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
November 15, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
Hazard: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
November 15, 2023Medical DevicesFDA
Philips Ultrasound, Inc. recalls Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 7
Hazard: Their is the potential that diagnostic ultrasound systems operating with software version 10.0 may present a delayed image instead of a real time image.
November 15, 2023Medical DevicesFDA
Encore Medical, LP recalls RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Hazard: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
November 15, 2023Medical DevicesFDA
Encore Medical, LP recalls RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant com
Hazard: Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Philips North America Llc recalls CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Hazard: Potential for units suspended on the ceiling to fail and fall.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls ORAL B MOUTH SORE RINSE 237ML, SKU 999087
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls FIRST RESPONSE 2 CT, SKU 902343
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls DENTEMP ONE STEP .077OZ, SKU 902139
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls VERIQUICK PREGNANCY TEST 1CT, SKU 901260
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SK
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls AT HOME MARIJUANA TEST STRIP, SKU 900752
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Family Dollar Stores, Llc. recalls CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Hazard: Products were stored outside of labeled temperature requirements.
November 15, 2023Medical DevicesFDA
Alcon Research, LLC recalls Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Hazard: Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
November 15, 2023Medical DevicesFDA
Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.
Hazard: Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL microprocessor chips and firmware.
November 15, 2023Medical DevicesFDA
Encore Medical, LP recalls DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Hazard: Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
November 15, 2023Medical DevicesFDA
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
Hazard: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.
November 15, 2023Medical DevicesFDA
Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
Hazard: An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.