510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

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

59,336 records, page 2 of 1187
FDA device recalls, page 2 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3183-2026Class IIREF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &...Stryker Sustainability SolutionsNLM
Z-3182-2026Class IIREF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY &...Stryker Sustainability SolutionsNLM
Z-3216-2026Class IIOlympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number...Olympus Corporation of the AmericasFGE
Z-3165-2026Class IINOxBOXi Nitric Oxide Delivery System.Noxbox LtdMRN
Z-3247-2026Class IIOlympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.Olympus Corporation of the AmericasKNS
Z-3246-2026Class IIOlympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.Olympus Corporation of the AmericasKNS
Z-3245-2026Class IIOlympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.Olympus Corporation of the AmericasKNS
Z-3244-2026Class IIOlympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.Olympus Corporation of the AmericasKNS
Z-3080-2026Class IBD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump...Bd Switzerland SarlFPA
Z-3155-2026Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product...Philips North America LlcJAK
Z-3298-2026Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAVH...Cardinal Health 200, LLCOJF
Z-3297-2026Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, GYN...Cardinal Health 200, LLCOHD
Z-3296-2026Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT,GU DAVINCI...Cardinal Health 200, LLCNWU
Z-3295-2026Presource Packs Containing Stryker StrykeFlow PS and AHTO tube sets: 1) KIT, LAP CHOLE...Cardinal Health 200, LLCLRO
Z-3325-2026Intrapulmonary Percussive Ventilation, IPV HC, Product Number: S00009; Phasitron, P5-HCPercussionaire CorporationNHJ
Z-3324-2026Travel Air, Product Number: S00055; Phasitron 5, Product Number: P5 used with Instruction...Percussionaire CorporationNHJ
Z-3323-2026Impulsator, Product Number: S00010, Phasitron 5, Product Number: P5 used with...Percussionaire CorporationNHJ
Z-3322-2026Intrapulmonary Percussive Ventilation, IPV-2C, Product Number: S00002-C; Phasitron 5...Percussionaire CorporationNHJ
Z-3321-2026Intrapulmonary Percussive Ventilation, IPV-1C, Product Number: S00002-C; Phasitron 5...Percussionaire CorporationNHJ
Z-3320-2026In-Line Valve, Product Number: P5-TEEPercussionaire CorporationMOD
Z-3319-2026Intrapulmonary Percussive Ventilation, IPV 1, Product Number: S00065; Phasitron 5...Percussionaire CorporationNHJ
Z-3035-2026Class IIPOWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double...OLYMPUS Corporation of the AmericasGEI
Z-3264-2026Class IIPRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a...Baxter Healthcare CorporationIOQ
Z-3263-2026Class IIPRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a...Baxter Healthcare CorporationIOQ
Z-3262-2026Class IIPRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technology (AMT) uses...Baxter Healthcare CorporationIOQ
Z-3291-2026Brand Name: Opportunity Pro Product Name: Opportunity Pro Model/Catalog Number: 72-50800...American Nitrile Operations LlcLZA
Z-3290-2026Brand Name: Opportunity Flex Product Name: Opportunity Flex Model/Catalog Number...American Nitrile Operations LlcLZA
Z-3289-2026Brand Name: Performance Pro Product Name: Performance Pro Model/Catalog Number...American Nitrile Operations LlcLZA
Z-3248-2026Class IIBrand Name: Pearle Vision 1 day Product Name: (somofilcon A) Contact Lens Model/Catalog...CooperVision, Inc.MVN
Z-3258-2026Class IICardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2...Intervascular, SasDSY
Z-3173-2026Class IIGM Helix Implant, REF: 109.984;Straumann USA LLCDZE
Z-3150-2026Class IImpella Optical Controller, Automated Impella Controller, Impella Connect Package with...Abiomed, Inc.OZD
Z-3149-2026Class IImpella Optical Controller with the below product descriptions and corresponding Product...Abiomed, Inc.OZD
Z-3148-2026Class IAutomated Impella Controller (AIC) with the below product descriptions and corresponding...Abiomed, Inc.OZD
Z-3288-2026Positron Emission Tomography and Computed Tomography System, Model: uMI 780Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-3287-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo S with...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-3286-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panvivo with...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-3285-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama GS with...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-3284-2026Positron Emission Tomography and Computed Tomography System, Model: uMI Panorama 35 with...Shanghai United Imaging Healthcare Co., Ltd.KPS
Z-3283-2026Positron Emission Tomography and Computed Tomography System, Model: uMI 550 with softwareShanghai United Imaging Healthcare Co., Ltd.KPS
Z-3282-2026Computed Tomography X-ray System, Model: uCT ATLAS Astound with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3281-2026Computed Tomography X-ray System, Model: uCT ATLAS with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3280-2026Computed Tomography X-ray System, Model: uCT 780 with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3279-2026Computed Tomography X-ray System, Model: uCT 760 with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3278-2026Computed Tomography X-ray System, Model: uCT 550 with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3277-2026Computed Tomography X-ray System, Model: uCT 530 with softwareShanghai United Imaging Healthcare Co., Ltd.JAK
Z-3127-2026Class IMedline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100...Medline Industries, LPOIB
Z-3126-2026Class IMedline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A...Medline Industries, LPMCY
Z-3125-2026Class IMedline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog...Medline Industries, LPLRS
Z-3124-2026Class IMedline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A...Medline Industries, LPLRO