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 109 of 1190
FDA device recalls, page 109 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0509-2025Class IIMEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL, REF...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-0508-2025Class IIMEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter ConnectorMEDLINE INDUSTRIES, LP - NorthfieldCAZ
Z-0486-2025Class IIAcrobat-i Vacuum Stabilizer System. Model Number C-OM-10000ZMaquet Cardiovascular LLCMWS
Z-0485-2025Class IIAcrobat SUV Vacuum Stabilizer System, ST. Model Number C-OM-9000ZMaquet Cardiovascular LLCMWS
Z-0484-2025Class IIAcrobat-i Positioner. Model Number C-XP-5000ZMaquet Cardiovascular LLCMWS
Z-0327-2025Class IBaxter AK 98 Dialysis Machine, Hemodialysis Delivery System, Product Code 955607. As of...Baxter Healthcare CorporationKDI
Z-0668-2025Class IBrand Name: Atlan Product Name: Atlan A300XL Model/Catalog Number: 8621400 The Atlan...Draeger, Inc.BSZ
Z-0667-2025Class IBrand Name: Atlan Product Name: Atlan A300 Model/Catalog Number: 8211300 The Atlan is...Draeger, Inc.BSZ
Z-0534-2025Class IIMedline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile.MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0533-2025Class II(1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2) Medline...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-0532-2025Class II(1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-0490-2025Class IIIa) Alcon Custom-Pak CONSTELLATION 25G PLUS CHRISTIANA CARE HLTH SERV, # 15340-11...Alcon LaboratoriesOJK
Z-0501-2025Class IIOrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport...OrganOx LimitedQQK
Z-0326-2025Class IITandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM...Smith & Nephew, Inc.KWY
Z-0305-2025Class IBrand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software...Draeger, Inc.BSZ
Z-0304-2025Class IBrand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software...Draeger, Inc.BSZ
Z-0505-2025Class IIDefibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View...Defibtech LLCMKJ
Z-0504-2025Class IIDefibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View...Defibtech LLCMKJ
Z-0503-2025Class IIDefibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline...Defibtech LLCMKJ
Z-0502-2025Class IIDefibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and...Defibtech LLCMKJ
Z-0499-2025Class IIApproach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789Cook IncorporatedDQX
Z-0535-2025Class IIVITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures...Ortho-Clinical Diagnostics, Inc.DCK
Z-0526-2025Class II4.5 x 180 mm REF 28208BKS Aggressive Cutter, sterile, 6x 3.5 x 70 mm REF 28206CBS Full...Karl Storz Endoscopy-America, Inc.HRX
Z-0325-2025Class IIHillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic...Baxter Healthcare CorporationDPS
Z-0324-2025Class IIHillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic...Baxter Healthcare CorporationBZG
Z-0323-2025Class IIHillrom Welch Allyn Vision Express Holter Analysis System; ElectrocardiographBaxter Healthcare CorporationMLO
Z-0322-2025Class IIHillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; ElectrocardiographBaxter Healthcare CorporationDPS
Z-0321-2025Class IIHillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress testBaxter Healthcare CorporationDPS
Z-0320-2025Class IIHillrom Welch Allyn HScribe Holter System; ambulatory monitoringBaxter Healthcare CorporationMLO
Z-0328-2025Class IBioZorb Marker. Radiographic soft tissue marker.Hologic, Inc.NEU
Z-0497-2025Class IIVue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model...Philips Medical Systems Technologies Ltd.LLZ
Z-0303-2025Class IBoston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000...Boston Scientific CorporationOAE
Z-0302-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160Boston Scientific CorporationOAE
Z-0301-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110Boston Scientific CorporationOAE
Z-0300-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER ST US, Material Number M004CRBS2060Boston Scientific CorporationOAE
Z-0299-2025Class IBoston Scientific POLARx FIT BALLOON CATHETER ST OUS, Material Number M004CRBS2010Boston Scientific CorporationOAE
Z-0298-2025Class IBoston Scientific POLARx BALLOON CATHETER LT 28MM OUS, Material Number M004CRBS2100Boston Scientific CorporationOAE
Z-0297-2025Class IBoston Scientific POLARx BALLOON CATHETER ST 28MM OUS, Material Number M004CRBS2000.Boston Scientific CorporationOAE
Z-0554-2025Class IIAutosampler, Models: SIL-40C XR CL, SIL-40C X3 CLShimadzu Corporation Analytical&measuring Instruments Div.KIE
Z-0553-2025Class IIAutosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CLShimadzu Corporation Analytical&measuring Instruments Div.KIE
Z-0649-2025Class IIMEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112J; 2) NEURO...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0648-2025Class IIMEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-0647-2025Class IIMEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985431J; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOKV
Z-0646-2025Class IIMEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760056G; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-0645-2025Class IIMEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-0644-2025Class IIMEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-0643-2025Class IIMEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I; 2) GYN...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-0642-2025Class IIMEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYNJ0531985R...MEDLINE INDUSTRIES, LP - NorthfieldMLT
Z-0641-2025Class IIMEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY SURG LARGE VAG...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-0640-2025Class IIMEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; 2) BASIC...MEDLINE INDUSTRIES, LP - NorthfieldOJG