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

59,336 records, page 5 of 1187
FDA device recalls, page 5 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3130-2026Class IStatStrip Glucose and B- Ketone meter. Model No: 63683. Glucose test system.Nova Biomedical CorporationPZI
Z-3105-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOJH
Z-3104-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOJG
Z-3103-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOJF
Z-3102-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOHM
Z-3101-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOHD
Z-3100-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOGR
Z-3099-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOFX
Z-3098-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCOEZ
Z-3097-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCNWU
Z-3096-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCLRP
Z-3095-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCLRO
Z-3094-2026Class IIPresource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)...Cardinal Health 200, LLCFDE
Z-3129-2026Class IStatStrip Glucose Hospital Meter System. Model No: 66739. Glucose test system.Nova Biomedical CorporationPZI
Z-3128-2026Class IStatStrip Glucose Hospital Meter System. Model No: 63685. Glucose test system.Nova Biomedical CorporationPZI
Z-3032-2026Class IIhealthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein...Healthmark Industries Co., Inc.SDC
Z-3031-2026Class IIhealthmark ProChek-II, Model Number PT-313, PT-201-12Healthmark Industries Co., Inc.SDC
Z-3047-2026Class IISTA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074...Diagnostica Stago, Inc.GGP
Z-3223-2026Class IIREF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post ValveVentec Life Systems, Inc.ECX
Z-3222-2026Class IIREF:HF2PC9 HomeFill Oxygen System, HomeFill Cylinder M9 with Integrated ConserverVentec Life Systems, Inc.ECX
Z-3221-2026Class IIHF2P0ST9 HomeFill Oxygen System HomeFill Cylinder M9 with CGA870 Compatible Post ValveVentec Life Systems, Inc.ECX
Z-3120-2026Class IIHeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI...HeartSine Technologies LtdMKJ
Z-3178-2026Class IIKinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006restor3d Inc.OYK
Z-3270-2026HeartSine samaritan PAD (Public Access Defibrillator); HeartSine SAM 350P 350P US...HeartSine Technologies LtdMKJ
Z-3231-2026Class IIVITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference...Biomerieux IncLON
Z-2940-2026Class IIAmi HTXSpectral Instruments IncRCE
Z-2939-2026Class IILago XSpectral Instruments IncRCE
Z-3331-2026Brand Name: Penumbra System (RED 62 Reperfusion Catheter) Product Name: Penumbra System...Penumbra Inc.NRY
Z-3181-2026Class IIBlood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs...Medical Action Industries, Inc. 306OFM
Z-3107-2026Class IKit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF...Medical Action Industries, Inc. 306OFT
Z-3106-2026Class IKit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP...Medical Action Industries, Inc. 306OGJ
Z-3137-2026Class IIMedline Convenience Kit: OPEN HEART A PACK, Product Number DYNJ43008NMedline Industries, LPLRO
Z-3088-2026Class IIVelys Enabling Tech Robotic-Assist Station REF: 451611001Medos International SARLOLO
Z-3261-2026Class IIHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL...AVID Medical, Inc.LRO
Z-3260-2026Class IIHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL...AVID Medical, Inc.LRO
Z-3194-2026Class IHalyard IV START KIT NON-STERILE; 48 kits per case. Containing BD ChloraPrep Clear - 1 mL...AVID Medical, Inc.LRO
Z-3188-2026Class IIBoston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1)...Boston Scientific CorporationFGB
Z-3030-2026Class IIFUJIFILM Synapse PACS software v7.4.310; radiological image processing systemFUJIFILM Healthcare Americas CorporationLLZ
Z-3004-2026Class IIMerge PACS and Merge OrthoPACS, medical imaging diagnostic workstationMerge Healthcare IncorporatedLLZ
Z-3039-2026Class IIFRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225GE Medical Systems Information Technologies, Inc.MWI
Z-3193-2026Class IICaptus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154;Mirion Technologies (Capintec), Inc.IZD
Z-3079-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3078-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-3077-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-3076-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR...MEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-3075-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-3074-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP...MEDLINE INDUSTRIES, LP - NorthfieldOJU
Z-3073-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD...MEDLINE INDUSTRIES, LP - NorthfieldOIB
Z-3072-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE...MEDLINE INDUSTRIES, LP - NorthfieldMCY
Z-3071-2026Class IIMedline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT...MEDLINE INDUSTRIES, LP - NorthfieldLRS