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 112 of 1190
FDA device recalls, page 112 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0467-2025Class IIBard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT 12G X 10 CM, REF...Bard Peripheral Vascular IncKNW
Z-0313-2025Class IIThe Access Cortisol assay is a paramagnetic particle, chemiluminescent immunoassay for...Siemens Healthcare Diagnostics Inc.CGR
Z-0279-2025Class IIAVOXimeter 1000E, Product Number: AVOX1000E. The AVOXimeter 1000E is a battery-operated...Accriva Diagnostics, Inc.DQA
Z-0263-2025Class II1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD...Westmed IncBZA
Z-0262-2025Class IIDuraform Dural Graft Implant, Size 3x3 , Model Number 80-1477US Lot CT007694Integra LifeSciences CorporationGXQ
Z-0276-2025Class IIKING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx...King Systems Corporation.CAE
Z-0275-2025Class IIKING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx...King Systems Corporation.CAE
Z-0274-2025Class IIKING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx...King Systems Corporation.CAE
Z-0273-2025Class IIKING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx...King Systems Corporation.CAE
Z-0272-2025Class IIKING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the...King Systems Corporation.CAE
Z-0271-2025Class IIKING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the...King Systems Corporation.CAE
Z-0270-2025Class IIKING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the...King Systems Corporation.CAE
Z-0269-2025Class IIAMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx...King Systems Corporation.CAE
Z-0319-2025Class IICoated VICRYL Polyglactin 910 Suture VIO 36IN(90CM) USP0(M3.5) S/A CT, Product Number...Ethicon, IncGAM
Z-0310-2025Class IMonoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777Medtronic, Inc.MEG
Z-0227-2025Class IElekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933, Diameter...Elekta Instrument ABHAW
Z-0315-2025Class IIintelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog...Biocare Medical LLCPPM
Z-1977-2025Class IIREF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, SterileOrthofix SRLHSB
Z-0286-2025Class IIepoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515Siemens Healthcare Diagnostics Inc.CHL
Z-0206-2025Class IIMedtronic Percept RC Implantable Neurostimulators (INS), Model B35300.Medtronic NeuromodulationMHY
Z-0283-2025Class IIBrand Name: Vial2Bag Advanced Product Name: Vial2Bag Advanced 20mm Admixture...West Pharmaceutical Services AZ, Inc.LHI
Z-0205-2025Class IIsmiths medical SurgiVet Advisor Tech Accessories, Product Code REF V2714Abbott MedicalDPT
Z-0204-2025Class IImedex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260Abbott MedicalDPT
Z-0203-2025Class IImedex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF...Abbott MedicalDPT
Z-0202-2025Class IImedex TranStar Stopcock w/Ext. 10/EA, Product Code REF MXG300242Abbott MedicalDPT
Z-0201-2025Class IImedex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA...Abbott MedicalDPT
Z-0200-2025Class IImedex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA...Abbott MedicalDPT
Z-0199-2025Class IImedex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA...Abbott MedicalDPT
Z-0198-2025Class IImedex TranStar KIDS KIT 31IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA...Abbott MedicalDPT
Z-0197-2025Class IImedex TranStar KIDS KIT 19IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA...Abbott MedicalDPT
Z-0196-2025Class IImedex TranStar Neonatal Monitoring Kit 10/EA, Product Code REF MX9530TAbbott MedicalDPT
Z-0195-2025Class IImedex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SCAbbott MedicalDPT
Z-0194-2025Class IImedex TranStar DPT w/Stopcock & 30cc Flush 10/EA, Product Code REF MX950SCNTAbbott MedicalDPT
Z-0193-2025Class IImedex TranStar DPT w/Stopcock & 3cc Flush 10/EA, Product Code REF MX950SCFTAbbott MedicalDPT
Z-0192-2025Class IImedex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505TAbbott MedicalDPT
Z-0191-2025Class IImedex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504TAbbott MedicalDPT
Z-0190-2025Class IImedex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502TAbbott MedicalDPT
Z-0189-2025Class IImedex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501TAbbott MedicalDPT
Z-0188-2025Class IImedex TranStar Disposable Transducer 1/EA, Product Code REF MX950Abbott MedicalDPT
Z-0187-2025Class IImedex Arterial Kit 1/EA, Product Code REF MX7827Abbott MedicalDPT
Z-0186-2025Class IImedex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740Abbott MedicalDPT
Z-0185-2025Class IImedex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1Abbott MedicalDPT
Z-0184-2025Class IImedex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086Abbott MedicalDPT
Z-0183-2025Class IImedex TranStar Single ICP Set 1/EA, Product Code REF MX20897Abbott MedicalGWM
Z-0182-2025Class IImedex TranStar Single OR Set 1/EA, Product Code REF MX20846R2Abbott MedicalGWM
Z-0232-2025Class IIQuest Spectrum 3 Fluorescent Imaging System Model/Catalog Number: ART-SYS-0029...OLYMPUS Corporation of the AmericasOWN
Z-0280-2025Class IIKLS Martin Battery Pack, REF: KLS BP2 001, and KLS BP2 040 (bulk case of 40), used in...Pro-Dex IncMOQ
Z-1857-2025Class IIELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb...Onkos Surgical, Inc.KRO
Z-0455-2025Class IIHalyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05Avid Medical, Inc. a Medical Action Ind. Company 305OES
Z-0454-2025Class IIHalyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02Avid Medical, Inc. a Medical Action Ind. Company 305OEZ