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 104 of 1190
FDA device recalls, page 104 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0778-2025Class IIMedline custom medical procedure kits labeled as: 1) OPEN HEART CDS-LF, REFCDS840451M...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0777-2025Class IIMedline custom medical procedure kits labeled as: 1) CATH LAB PACK-LF, REF...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-0706-2025Class IIOEC 9800 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The Series OEC 9800...GE HealthcareOXO
Z-0705-2025Class IIOEC 9900 REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 9900 Elite...GE HealthcareOXO
Z-0704-2025Class IIOEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile...GE HealthcareOXO
Z-0703-2025Class IIOEC 3D REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC 3D is a mobile...GE HealthcareOXO
Z-0774-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG...Medtronic NeuromodulationLKK
Z-0773-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG...Medtronic NeuromodulationLKK
Z-0772-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG...Medtronic NeuromodulationLKK
Z-0771-2025Class IISynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG...Medtronic NeuromodulationLKK
Z-0753-2025Class IIThe Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a...Abbott MedicalPNJ
Z-0686-2025Class IIPhilips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216Philips North America LLCMHX
Z-0683-2025Class IStatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number: 63910...Nova Biomedical CorporationN/A
Z-0682-2025Class IStatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. Prescription...Nova Biomedical CorporationN/A
Z-0681-2025Class IStatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescription use...Nova Biomedical CorporationPZI
Z-0796-2025Class IISUC-4300S, Rigid Intracardiac Sucker Fluted Tip; 1/4" (6.4mm) connector 13" (33cm)...Med Michigan Holdings LLCGCX
Z-0776-2025Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code...Baxter Healthcare CorporationFRN
Z-0775-2025Class IIBaxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code...Baxter Healthcare CorporationFRN
Z-0802-2025Class IIVacuette Safelink, Ref: 450210Greiner Bio-One GmbHFMI
Z-0707-2025Class IIDuravent Silicone Ventilation Tube. Model Number: 240075.OLYMPUS Corporation of the AmericasETD
Z-1042-2025Class IIMedline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number...MEDLINE INDUSTRIES, LP - NorthfieldOXQ
Z-1041-2025Class IIMedline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-1040-2025Class IIMedline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130; 2)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0806-2025Class IIEnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product...Elucent Medical IncNEU
Z-0818-2025Class IITec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEVGE HealthcareCAD
Z-0817-2025Class IITec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISOGE HealthcareCAD
Z-0816-2025Class IITec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEVGE HealthcareCAD
Z-0815-2025Class IITec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISOGE HealthcareCAD
Z-0814-2025Class IITec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000...GE HealthcareCAD
Z-0698-2025Class IIHUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B...MEDLINE INDUSTRIES, LP - NorthfieldCBH
Z-0697-2025Class IIHUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube...MEDLINE INDUSTRIES, LP - NorthfieldCBH
Z-0696-2025Class IIHUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B...MEDLINE INDUSTRIES, LP - NorthfieldCBH
Z-0695-2025Class IIHUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube...MEDLINE INDUSTRIES, LP - NorthfieldCBH
Z-0727-2025Class IIAccess hsTnI Reagent, REF B52699, Immunoassay Method, Troponin Subunit. For the...Siemens Healthcare Diagnostics Inc.MMI
Z-0583-2025Class IISpectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.Philips North America LLCJAK
Z-0710-2025Class IImint Lesion, Software Versions: 3.10.0 and 3.10.1.Mint Medical GmbHLLZ
Z-0709-2025Class IImint Lesion, Software Versions: 3.9.0 through 3.9.5.Mint Medical GmbHLLZ
Z-0692-2025Class IIBrand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number...CooperSurgical, Inc.PUB
Z-0691-2025Class IIBrand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K24012 Software...CooperSurgical, Inc.PUB
Z-0690-2025Class IIBrand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number...CooperSurgical, Inc.PUB
Z-0689-2025Class IIBrand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number...CooperSurgical, Inc.PUB
Z-0688-2025Class IIBrand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number...CooperSurgical, Inc.PUB
Z-0687-2025Class IIBrand Name: K-Systems Product Name: G73 Dry Bath Incubator Model/Catalog Number...CooperSurgical, Inc.PUB
Z-0660-2025Class IOptikon Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: OPT14-5011. Product...Kirwan Surgical Products, LLCGEI
Z-0659-2025Class INidek Co. Disposable Bipolar Pencil 25 Gauge Straight. Model/Catalog Number...Kirwan Surgical Products, LLCGEI
Z-0658-2025Class IWalcott Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: RX14-5011. Product...Kirwan Surgical Products, LLCGEI
Z-0657-2025Class IAmbler Surgical Bipolar Pencil 25 Gauge Straight. Model/Catalog Number: PD7226. The...Kirwan Surgical Products, LLCGEI
Z-0656-2025Class IAccutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight...Kirwan Surgical Products, LLCGEI
Z-0655-2025Class IKirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long...Kirwan Surgical Products, LLCGEI
Z-0654-2025Class IKirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight. Model/Catalog...Kirwan Surgical Products, LLCGEI