FDA Device · 2023
FDA Device recalls in 2023
RecallRadar indexes 2,477 FDA Device recall notices published in 2023. By classification: 495 Class I, 1,959 Class II, 23 Class III.
- Mobilett Mira wireless (VA20) mobile x-ray system(s)
FDA Device · Class II · 2023-11-22 · Siemens Medical Solutions Usa - LIFEPAK 15, REF: 99577-000055, Part Number V15-2-000061
FDA Device · Class II · 2023-11-22 · Physio Control - PERIPHERAL BLOOD CULTURE DRAW, REF DYNDH1561
FDA Device · Class II · 2023-11-22 · Medline Industries Northfield - KWIKSTIK, P. venetum, Catalog numbers: a) 0794P (2-pack), b) 0794K (6-pack)
FDA Device · Class II · 2023-11-22 · Microbiologics - LIFEPAK 15, REF: 99577-001955, Part Number V15-5-000584 and V15-7-000020
FDA Device · Class II · 2023-11-22 · Physio Control - Brilliance CT Big Bore with software version V4.8.0.10421 Model:728244 CT scanner and simulator designed for radiation oncology and therapy
FDA Device · Class II · 2023-11-22 · Philips North America - LYFO-DISK, P. venetum, Catalog number 0794L
FDA Device · Class II · 2023-11-22 · Microbiologics - LIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023
FDA Device · Class II · 2023-11-22 · Physio Control - LIFEPAK 15, REF: 99577-000046, Part Number V15-2-000051
FDA Device · Class II · 2023-11-22 · Physio Control - Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy
FDA Device · Class II · 2023-11-22 · Philips North America - LIFEPAK 15, REF: 99577-001255, Part Number V15-2-001602
FDA Device · Class II · 2023-11-22 · Physio Control - EVIS EXERA III Gastrointestinal Videoscope
FDA Device · Class II · 2023-11-15 · Olympus - LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only
FDA Device · Class II · 2023-11-15 · Magellan Diagnostics - TERUMO 60" TUBE SET W/HIGH CRACK CHK VLV, Article No. 7S3070
FDA Device · Class II · 2023-11-15 · B Braun Medical - RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF: 509-03-432, orthopedic shoulder implant component
FDA Device · Class II · 2023-11-15 · Encore Medical - Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-180-015
FDA Device · Class II · 2023-11-15 · Stryker - DigitalDiagnost 4 Flex/Value, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - CardioMEMS Patient Electronic System (PES), Model Number CM1100
FDA Device · Class II · 2023-11-15 · St Jude Medical - Stryker, REF: CAT00241, Portal Entry Kit consisting of a skin marker, disposable ruler, (2) FlexSticks, 30 ml syringe, and (2) 17 Ga Needles
FDA Device · Class II · 2023-11-15 · Stryker - Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35
FDA Device · Class II · 2023-11-15 · Edwards Lifesciences - AT HOME MARIJUANA TEST STRIP, SKU 900752
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-230-005
FDA Device · Class II · 2023-11-15 · Stryker - DigitalDiagnost C90 Release 3, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-180-005
FDA Device · Class II · 2023-11-15 · Stryker - Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-200-015
FDA Device · Class II · 2023-11-15 · Stryker - Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-200-005
FDA Device · Class II · 2023-11-15 · Stryker - DigitalDiagnost 4 Chest/Emergency, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System, with StealthStation Cranial software, is inte…
FDA Device · Class I · 2023-11-15 · Medtronic Navigation - DigitalDiagnost 4 High Performance, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm systems
FDA Device · Class II · 2023-11-15 · Philips North America - Cardiohelp-i, blood oxygenation and carbon dioxide removal system, Part Numbers 701072780 (Cardiohelp-i), 701068550 (Slide Rail Holder)
FDA Device · Class II · 2023-11-15 · Maquet Medical Systems Usa - Veradius Unity Mobile Surgery C-arm
FDA Device · Class II · 2023-11-15 · Philips North America - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T180, BF-1TQ180, BF-P180
FDA Device · Class I · 2023-11-15 · Olympus - BD Alaris PCU REF 8015
FDA Device · Class I · 2023-11-15 · Carefusion 303 - BD Alaris Syringe Module, REF 8110
FDA Device · Class I · 2023-11-15 · Carefusion 303 - DigitalDiagnost C90 Release 3.1, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-230-005
FDA Device · Class II · 2023-11-15 · Stryker - Philips Affiniti 70, Diagnostic Ultrasound System Model # 795210
FDA Device · Class II · 2023-11-15 · Philips Ultrasound - CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - DigitalDiagnost C90 Flex/Value/Chest/ER, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - Azurion IGTS Fixed Systems
FDA Device · Class II · 2023-11-15 · Philips North America - Arial Water Resistant Pendant with Long Wristband, Models: 59362 and 2560-59362
FDA Device · Class II · 2023-11-15 · Securitas Healthcare - 30 ML 2PORT BURETTE ASSEMBLY, Article No. 7A3950, used in a contrast management system
FDA Device · Class II · 2023-11-15 · B Braun Medical - Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-200-010
FDA Device · Class II · 2023-11-15 · Stryker - CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
FDA Device · Class II · 2023-11-15 · Philips North America - Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-230-010
FDA Device · Class II · 2023-11-15 · Stryker - Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.5MM, Catalog Number 6780-230-015
FDA Device · Class II · 2023-11-15 · Stryker - ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - Arial Water Resistant Pendant with Wristband, Models: 59361 and 2560-59361
FDA Device · Class II · 2023-11-15 · Securitas Healthcare - GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN OVRNT TAB 40CT, SKU 906023
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - EasyDiagnost Eleva DRF, Release 5, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-P190
FDA Device · Class I · 2023-11-15 · Olympus - Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software
FDA Device · Class II · 2023-11-15 · Change Healthcare Canada - ORAL B MOUTH SORE RINSE 237ML, SKU 999087
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - Zenition 50 & 70 Mobile Surgery C-arm
FDA Device · Class II · 2023-11-15 · Philips North America - Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR
FDA Device · Class II · 2023-11-15 · Alcon Research - Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-180-015
FDA Device · Class II · 2023-11-15 · Stryker - DENTEMP ONE STEP .077OZ, SKU 902139
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Number Q180-AC
FDA Device · Class I · 2023-11-15 · Olympus - Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catalog Number 6780-200-005
FDA Device · Class II · 2023-11-15 · Stryker - ProxiDiagnost N90, Radiography and Fluoroscopy (R/F) system
FDA Device · Class II · 2023-11-15 · Philips North America - Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 0.5MM TIP, Catalog Number 6770-200-005
FDA Device · Class II · 2023-11-15 · Stryker - DJO EMPOWR Knee Punch Handle, REF: 801-05-040
FDA Device · Class II · 2023-11-15 · Encore Medical - DigitalDiagnost C90 High Performance, used to acquire, process, store, display and export digital radiographic images
FDA Device · Class II · 2023-11-15 · Philips North America - Alaris PCA Module 8120
FDA Device · Class I · 2023-11-15 · Carefusion 303 - FT1000S FLUID TRANSFER SET, REF No. 356048
FDA Device · Class II · 2023-11-15 · B Braun Medical - SA3000 VENTED MICRO SPIKE ADAPTER, REF No. 418121, for intravenous use
FDA Device · Class II · 2023-11-15 · B Braun Medical - Novum IQ Syringe infusion system, Product Code 40800BAXUS
FDA Device · Class I · 2023-11-15 · Baxter Healthcare - Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-230-005
FDA Device · Class II · 2023-11-15 · Stryker - VERIQUICK PREGNANCY TEST 1CT, SKU 901260
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - Allura Xper IGTS Fixed Systems
FDA Device · Class II · 2023-11-15 · Philips North America - THERASPHERE ADMIN SET, Article No. 7M2650
FDA Device · Class II · 2023-11-15 · B Braun Medical - Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter
FDA Device · Class I · 2023-11-15 · Cordis Us - BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component
FDA Device · Class II · 2023-11-15 · B Braun Medical - Zephyr Endobronchial Valve (EBV) 5.5-LP, REF: EBV-TS-5.5-LP
FDA Device · Class II · 2023-11-15 · Pulmonx - BREG REF 100519-000 WALKER FOLDING WALKER WITH WHEELS Utilized as a walking aid
FDA Device · Class II · 2023-11-15 · Breg - Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catalog Number 6780-230-010
FDA Device · Class II · 2023-11-15 · Stryker - AMO ADMINISTRATION SET, Article No. 7A3817, REF OM2505191, for ophthalmologic use
FDA Device · Class II · 2023-11-15 · B Braun Medical - The DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. the system consis…
FDA Device · Class II · 2023-11-15 · Carestream Health - FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402 FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015
FDA Device · Class II · 2023-11-15 · Stryker - EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS Model Number BF-XT190
FDA Device · Class I · 2023-11-15 · Olympus - ALLERGAN UNIVERSAL FILL KIT, REF No. 7M2804. for tissue expander inflation
FDA Device · Class II · 2023-11-15 · B Braun Medical - RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component
FDA Device · Class II · 2023-11-15 · Encore Medical - Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.0MM TIP, Catalog Number 6760-230-010
FDA Device · Class II · 2023-11-15 · Stryker - MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - FIRST RESPONSE 2 CT, SKU 902343
FDA Device · Class II · 2023-11-15 · Family Dollar Stores - EVIS EXERA III BRONCHOVIDEOSCOPE Model Numbers BF-1TH190, BF-H190, BF-Q190 and BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 Model Number BF-Q170
FDA Device · Class I · 2023-11-15 · Olympus - Disposable Spetzler-Malis Bipolar forceps, 20CM IM DISP BAYONET 1.5MM TIP, Catalog Number 6770-200-015
FDA Device · Class II · 2023-11-15 · Stryker - Integris-Allura IGTS Fixed Systems
FDA Device · Class II · 2023-11-15 · Philips North America - Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Catalog Number 6770-180-010
FDA Device · Class II · 2023-11-15 · Stryker - CONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112
FDA Device · Class II · 2023-11-15 · Young Dental Manufacturing I - Arial Water Resistant Pendant with Neck Lanyard, Models: 59360 and 2560-59360
FDA Device · Class II · 2023-11-15 · Securitas Healthcare - Philips EPIQ Diagnostic Ultrasound System Models: EPIQ 7G(model # 795200), EPIQ 7C (Model # 795201), EPIQ 7W (Model # 795202), EPIQ 5G (mod…
FDA Device · Class II · 2023-11-15 · Philips Ultrasound - Disposable Spetzler-Malis Bipolar forceps, 18CM SM DISP BAYONET 0.5MM TIP, Catalog Number 6760-180-005
FDA Device · Class II · 2023-11-15 · Stryker - BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Numbers BF-1T150, BF-1T60, BF-P150 BF-P60 and EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Model Nu…
FDA Device · Class I · 2023-11-15 · Olympus - 30ML BURETTE ASSY WITH STOPCOCK, BNS, Article No. 7A3970. used in a contrast management system
FDA Device · Class II · 2023-11-15 · B Braun Medical - VITROS Chemistry Products Lipase Slides, Product Codes 1668409 (contains 60 Slides per Cartridge) and 8297749 (contains 18 slides per cartr…
FDA Device · Class II · 2023-11-15 · Ortho Clinical Diagnostics - Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators
FDA Device · Class II · 2023-11-15 · Percussionaire - RX Daytona Plus (without ISE)- IVD Clinical Chemistry Analyser (1) RX4041, (2) RX4041R (refurbished)
FDA Device · Class II · 2023-11-08 · Randox Laboratories
Other years
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