Medical device recalls
39137 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2023-11-15FDA-DeviceCarestream Health, Inc.Class IIThe DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consists of a self-contained x-ray generator, image receptor(s), imaging display and software for acquiring medical diagnostic images outside of standard stationary x-ray room. The DRX-Revolution system incorporates a flat-panel detector that can be used wirelessly for exams such as in-bed chest projections. The system can also be used to expose CR phosphor screens
There is a potential for unexpected failure of the electrical components within the Carestream Health Inc. generator installed in your DRX-Revolution Mobile X-ray System(s). This can lead to temporary and self contained thermal overload within the generator. Should an event like this occur, the system will become inoperable and loud noise, burnt smell and smoke may be detectable.
- 2023-11-15FDA-DeviceOlympus Corporation of the AmericasClass IIEVIS EXERA III Gastrointestinal Videoscope
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
- 2023-11-15FDA-DeviceStryker CorporationClass IIStryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles. Used to aid the surgeon in establishing arthroscopic portals and joint access.
Expired product distributed
- 2023-11-15FDA-DeviceCordis US CorpClass ICordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
Non-sterile product labeled as sterile was distributed.
- 2023-11-15FDA-DeviceYoung Dental Manufacturing I, LLCClass IICONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis Angles
one lot of Contra Gray (soft) Turbo Plus Cups Dental Prophylaxis Angles may contain Contra Petite Web LF Soft Purple Cup DPAs.
- 2023-11-15FDA-DevicePhilips Ultrasound, Inc.Class IIPhilips Affiniti 70, Diagnostic Ultrasound System Model # 795210
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.
- 2023-11-15FDA-DevicePhilips Ultrasound, Inc.Class IIPhilips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (model # 795204), EPIQ 5W (model # 795206), EPIQ CVx (Model # 795231), EPIQ Elite (model # 795234)
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.
- 2023-11-15FDA-DeviceEncore Medical, LPClass IIRSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
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.
- 2023-11-15FDA-DeviceEncore Medical, LPClass IIRSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component.
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.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIEasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IIDigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images.
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DevicePhilips North America LlcClass IICombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Potential for units suspended on the ceiling to fail and fall.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIORAL B MOUTH SORE RINSE 237ML, SKU 999087
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIMEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIGOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIFIRST RESPONSE 2 CT, SKU 902343
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIDENTEMP ONE STEP .077OZ, SKU 902139
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIVERIQUICK PREGNANCY TEST 1CT, SKU 901260
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIFIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IIAT HOME MARIJUANA TEST STRIP, SKU 900752
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceFamily Dollar Stores, Llc.Class IICLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
Products were stored outside of labeled temperature requirements.
- 2023-11-15FDA-DeviceAlcon Research, LLCClass IIAlcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
Custom surgical procedure packs contain latex gloves but are labeled as "latex free".
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