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

59,460 records, page 108 of 1190
FDA device recalls, page 108 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0354-2025Class IIClean Catch Kit, SKU DYKM1833A; Component No. 503581MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0666-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV19Micro-X Ltd.IZL
Z-0569-2025Class IIBaxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Part Number...Baxter Healthcare CorporationKDJ
Z-0568-2025Class IIBaxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Part Number...Baxter Healthcare CorporationKDJ
Z-0567-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use...Baxter Healthcare CorporationKDJ
Z-0566-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use...Baxter Healthcare CorporationKDJ
Z-0565-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use...Baxter Healthcare CorporationKDJ
Z-0564-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use...Baxter Healthcare CorporationKDJ
Z-0563-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use...Baxter Healthcare CorporationKDJ
Z-0562-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use...Baxter Healthcare CorporationKDJ
Z-0561-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use...Baxter Healthcare CorporationKDJ
Z-0560-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use...Baxter Healthcare CorporationKDJ
Z-0559-2025Class IIBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use...Baxter Healthcare CorporationKDJ
Z-0800-2025Class IIIvalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx 3.0 cm...Carwild Corp.HOZ
Z-0799-2025Class IIIvalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgical...Carwild Corp.HOZ
Z-0798-2025Class IIIvalon Eye Wick 20cm- Intended to be used for the removal and collection of fluids from...Carwild Corp.HOZ
Z-0580-2025Class IIMICRO-X Rover Mobile X-ray System, # MXU-RV35Micro-X Ltd.IZL
Z-0482-2025Class IAllegedly counterfeit batteries manufactured by CSB batteries being used with Plum...Abbott MedicalFRN
Z-0465-2025Class IIMedline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ04049 (cases)...MEDLINE INDUSTRIES, LP - NorthfieldLRW
Z-0599-2025Class IIAtellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative...Siemens Healthcare Diagnostics Inc.JZG
Z-0496-2025Class IISiemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate...Siemens Healthcare Diagnostics Inc.JJE
Z-0363-2025Class IIIrrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set...Karl Storz Endoscopy-America, Inc.NVT
Z-0477-2025Class IIJuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357Zimmer GmbHKDD
Z-0382-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part Number...Baxter Healthcare CorporationKDJ
Z-0381-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T5C4482; use...Baxter Healthcare CorporationKDJ
Z-0380-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4484; use...Baxter Healthcare CorporationKDJ
Z-0379-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4483; use...Baxter Healthcare CorporationKDJ
Z-0378-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482E; use...Baxter Healthcare CorporationKDJ
Z-0377-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R5C4482; use...Baxter Healthcare CorporationKDJ
Z-0376-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4483; use...Baxter Healthcare CorporationKDJ
Z-0375-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482S; use...Baxter Healthcare CorporationKDJ
Z-0374-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482EJ; use...Baxter Healthcare CorporationKDJ
Z-0373-2025Class IBaxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5C4482; use...Baxter Healthcare CorporationKDJ
Z-1251-2025Class IIhuman med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107...Human Med AGQPB
Z-0571-2025Class IIEssenz HLM (Heart-Lung Machine), REF: 49-00-10, with SoftwareLivaNova Deutschland GmbHDTQ
Z-0506-2025Class IIZ-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800...Zyno Medical LLC.FRN
Z-0495-2025Class IIAbbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, SterileAbbott MedicalNPT
Z-0494-2025Class IIAbbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, NVRO-27...Abbott MedicalNPT
Z-0493-2025Class IIAbbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NVRO-29...Abbott MedicalNPT
Z-0492-2025Class IIAbbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, SterileAbbott MedicalNPT
Z-0491-2025Class IIAbbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 35 mm...Abbott MedicalNPT
Z-0489-2025Class IIcobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, for use on...Roche Diagnostics GmbHLPS
Z-2537-2025Class IICorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix, 5.0 mm x...Corneat Vision, Ltd.QWU
Z-0804-2025Class IISmaxel Fractional CO2 Laser, a Class IV medical laser system.IDS LtdONG
Z-0515-2025Class IIMEDLINE procedure kits labeled as follows: 1) L&D CONTINUOUS EPIDURAL TRAY, REF...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-0514-2025Class IIMEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876AMEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-0513-2025Class IIMEDLINE procedure kits labeled as follows: 1) CONT EPI 20G W/HUSTEAD, REF...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0512-2025Class IIMEDLINE procedure kits labeled as follows: 1) PERIPHERAL CONTINUOUS NERVE BL, REF...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0511-2025Class IIMEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET, REF...MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-0510-2025Class IIMEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE, REF...MEDLINE INDUSTRIES, LP - NorthfieldOGE