510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Device recalls

Recall records from FDA, newest initiation date first.

Every device recall MDM has ingested. The recall record supplies the product, the reason and the product code; the matching enforcement report supplies the Class I, II or III classification. Where the two have not been joined, the class is left blank rather than assumed.

Data as of , the FDA export date. FDA medical device recall database

59,460 records, page 178 of 1190
FDA device recalls, page 178 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0399-2024Class IIORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for...BizLink Robotic Solutions FranceJAI
Z-0398-2024Class IIORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for...BizLink Robotic Solutions FranceJAI
Z-0406-2024Class IIDa Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mmIntuitive Surgical, Inc.NAY
Z-0285-2024Class IICONTRA GRAY (soft) TURBO PLUS CUPS, REF 153112. Dental Prophylaxis AnglesYoung Dental Manufacturing Co 1, LLC.EGS
Z-1552-2025Class IIMEDFLEX, REF: 1119-00; MEDBANK MAIN, REF: 1137-00; MEDFLEX 2.0, REF: 1139-00; MEDBANK...CareFusion 303, IncBRY
Z-0626-2024Class IIREF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2Encore Medical, LPPHX
Z-0625-2024Class IIReverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm...Encore Medical, LPPHX
Z-0548-2024Class ICereLink ICP Extension Cable (Extension Cable), Model No. 826845 Used with Codman...Integra LifeSciences CorporationGWM
Z-0223-2024Class IIMobilett Mira wireless (VA20) mobile x-ray system(s)Siemens Medical Solutions USA, Inc.IZL
Z-2501-2025Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user...Visgeneer, Inc.PTC
Z-2500-2025Class IIBlood Uric Acid Monitoring System Each kit contains 1 meter, 1 lancing device, user...Visgeneer, Inc.PTC
Z-0229-2024Class IIAzurion IGTS Fixed SystemsPhilips North America LLCOWB
Z-0228-2024Class IIAllura Xper IGTS Fixed SystemsPhilips North America LLCOWB
Z-0227-2024Class IIIntegris-Allura IGTS Fixed SystemsPhilips North America LLCOWB
Z-0226-2024Class IIZenition 50 & 70 Mobile Surgery C-armPhilips North America LLCOWB
Z-0230-2024Class IIVeradius Unity Mobile Surgery C-armPhilips North America LLCOWB
Z-0414-2024Class IITruWave with Vamp System Pressure monitoring set, REF: PXAVMP(3cc)/VAMP 68 in...Edwards Lifesciences LLCDRS
Z-0224-2024Class IIBV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surgery C-arm...Philips North America LLCOWB
Z-0413-2024Class IITruWave Pressure monitoring set, REF: PX212: cc/12 in (30cm), PX260: (3 cc/60in (150cm)...Edwards Lifesciences LLCDRS
Z-0412-2024Class IIFloTrac Sensor with Vamp System, REF: MHD6AZ, MHD6AZ5 , MHD6C502 STIRLEEO, Rx only. For...Edwards Lifesciences LLCDRS
Z-0411-2024Class IIFloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For...Edwards Lifesciences LLCDRS
Z-0410-2024Class IIAcumen IQ Sensor with VAMP System, REFs: AIQS6AZ & AIQS6AZ5, STERILEEO, Rx only. For use...Edwards Lifesciences LLCDRS
Z-0409-2024Class IIAcumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only...Edwards Lifesciences LLCDRS
Z-0400-2024Class IIBD Insyte Autoguard BC Shielded IV Catheter with Blood Control Technology 20GA X 1.00in...Becton Dickinson Infusion Therapy Systems Inc.FOZ
Z-0270-2024Class IIOral B Mouth Sore Rinse 237Ml, Sku 999087Family Dollar StoresNTO
Z-0269-2024Class IIMEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935Family Dollar StoresLYL
Z-0268-2024Class IIArc Teeth Whitening Pen 0.06 Fl Oz, Sku 997950Family Dollar StoresMAU
Z-0267-2024Class IIGoodsense Denture Cleanser Grn Tab 40Ct, Sku 906312 Goodsense Denture Clean Ovrnt Tab...Family Dollar StoresEFT
Z-0266-2024Class IIFirst Response 2 CT, Sku 902343Family Dollar StoresLCX
Z-0265-2024Class IIDentemp One Step .077Oz, Sku 902139Family Dollar StoresEMA
Z-0264-2024Class IIVeriquick Pregnancy Test 1Ct, Sku 901260Family Dollar StoresLCX
Z-0263-2024Class IIFixodent Org Cream 2.4Oz, Sku 906018 Fixodent Adh Cream with Scope 2Oz, Sku...Family Dollar StoresKOO
Z-0262-2024Class IIAt Home Marijuana Test Strip, Sku 900752Family Dollar StoresLDJ
Z-0261-2024Class IIClearblue Smart Countdown Prgncy Tst 1Ct, Sku 900260Family Dollar StoresLCX
Z-0212-2024Class IIHILLROM PROGRESSA+ BED, Product Codes: P7501A000016, P7501A000019, P7501A000031...Baxter Healthcare CorporationIOQ
Z-0218-2024Class IICardioMEMS Patient Electronic System (PES), Model Number CM1100. Used for wirelessly...Abbott MedicalMOM
Z-0352-2024Class IITina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material...Roche Diagnostics GmbHGHH
Z-1658-2025Class IIEdge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL, 10/PK...Edge Biologicals, Inc.QMC
Z-0568-2024Class IIACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA...OLYMPUS Corporation of the AmericasFAS
Z-0490-2024Class IISTAT-Site M BHB Test Strips, used with STAT-SITE M Beta-HB Meter as an in vitro...Stanbio LaboratoryJIN
Z-0289-2024Class IIThe DRX-Revolution Mobile X-Ray System is a diagnostic mobile x-ray system utilizing...Eastman Kodak CompanyIZL
Z-0437-2024Class IIDRX Revolution Mobile X-Ray SystemEastman Kodak CompanyIZL
Z-0288-2024Class IIEVIS EXERA III Gastrointestinal VideoscopeOLYMPUS Corporation of the AmericasFDF
Z-0204-2024Class IICoapt ControlSeal Electrode, cutaneous EMG ElectrodeCoapt LLCGXY
Z-0203-2024Class IICoapt Dome Electrode, Gen2 system, cutaneous electrodeCoapt LLCGXY
Z-0484-2024Class IIAtrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.Atrium Medical CorporationGBZ
Z-0305-2024Class IILIFEPAK 15, REF: 99577-001960, Part Number: V15-7-000026Physio Control, Inc.MKJ
Z-0304-2024Class IILIFEPAK 15, REF: 99577-001958, Part Number: V15-7-000023Physio Control, Inc.MKJ
Z-0303-2024Class IILIFEPAK 15, REF: 99577-001957, Part Number V15-5-000586 and V15-7-000022Physio Control, Inc.MKJ
Z-0302-2024Class IILIFEPAK 15, REF: 99577-001956, Part Number V15-7-000021Physio Control, Inc.MKJ