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 60 of 1190
FDA device recalls, page 60 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0145-2026Class IIBrand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis...Kico Knee Innovation CompanySBF
Z-0489-2026Class IIBrand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number...Abbott MedicalGKZ
Z-0157-2026Class IILOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533GE HealthcareIYN
Z-0156-2026Class IILOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number...GE HealthcareIYN
Z-0155-2026Class IILOGIQ P10 series with software version R4.5.7 Model Number 5877534GE HealthcareIYN
Z-0288-2026Class IIHeartSine Pad-Pak, REF: PAD-PAK-01, PAD-PAK-02, PAD-PAK-03, PAD-PAK-04, PAD-PAK-07...HeartSine Technologies LtdMKJ
Z-0043-2026Class IZenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part...Cook Medical LLCMIH
Z-0126-2026Class IIDesign Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product...B Braun Medical IncOGE
Z-0125-2026Class IICombined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy...B Braun Medical IncOGE
Z-0124-2026Class IIDesign Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK...B Braun Medical IncOGE
Z-0123-2026Class IICombined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy...B Braun Medical IncOGE
Z-0122-2026Class IIESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm)...B Braun Medical IncOGE
Z-0121-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x...B Braun Medical IncOGE
Z-0120-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy...B Braun Medical IncOGE
Z-0119-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy...B Braun Medical IncOGE
Z-0118-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy...B Braun Medical IncOGE
Z-0117-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm)...B Braun Medical IncOGE
Z-0116-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm)...B Braun Medical IncOGE
Z-0115-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm)...B Braun Medical IncOGE
Z-0211-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" PVC...Medtronic, Inc.FEG
Z-0210-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stomach Tube, Dual...Medtronic, Inc.KNT
Z-0209-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-Reflux Valve...Medtronic, Inc.KNT
Z-0208-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Silicone Dual...Medtronic, Inc.KNT
Z-0207-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stomach Tube, Dual...Medtronic, Inc.KNT
Z-0158-2026Class IIAirvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User...Fisher & Paykel Healthcare, Inc.BTT
Z-0206-2026Class IISalem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SALEM SUMP" PVC...Medtronic, Inc.FEG
Z-0114-2026Class IIPERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm)...B Braun Medical IncOGE
Z-0725-2026Class IIInSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit...Enterix, Inc.KHE
Z-0230-2026Class IIFuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS200401...CPM Medical Consultants, LLC.HRS
Z-0441-2026Class IISYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706Siemens Healthcare Diagnostics Inc.MRR
Z-0233-2026Class IIOral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690...Baxter Healthcare CorporationFLL
Z-0503-2026Class IIMOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 &...Elekta Solutions ABIYE
Z-0031-2026Class IPhasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20...Percussionaire Corp.BZO
Z-0325-2026Class IISurgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmented realitySurgical Theater IncLLZ
Z-0324-2026Class IISpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software...Surgical Theater IncSFB
Z-0323-2026Class IIEndo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), software...Surgical Theater IncLLZ
Z-0322-2026Class IISyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP), software...Surgical Theater IncLLZ
Z-0321-2026Class IISurgical Navigation Advanced Platform Patient Engagement (PE SNAP), software version...Surgical Theater IncLLZ
Z-0320-2026Class IISurgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, imaging...Surgical Theater IncLLZ
Z-0319-2026Class IISuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radiological...Surgical Theater IncLLZ
Z-0580-2026Class IICatalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding...Medtronic Sofamor Danek USA IncMAX
Z-0416-2026Class IIBrand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 92810 Software...GE HealthcareDQK
Z-0136-2026Class IAutomated Impella Controller (AIC) labeled as the following with corresponding Product...Abiomed, Inc.OZD
Z-0581-2026Class IICONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+...Alcon LaboratoriesHQB
Z-0044-2026Class IIFDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566-16130-31...FUJIFILM Healthcare Americas CorporationKPR
Z-0487-2026Class IIAffinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous...Medtronic Perfusion SystemsDTZ
Z-0225-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed...UIH Technologies LLCJAK
Z-0224-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed...UIH Technologies LLCJAK
Z-0223-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed...UIH Technologies LLCJAK
Z-0222-2026Class IIShanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed...UIH Technologies LLCJAK