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 115 of 1190
FDA device recalls, page 115 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0215-2025Class IIBaxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082Baxter Healthcare CorporationJEA
Z-0214-2025Class IIBaxter Operating Table TruSystem 7000 V, Product code REF 1841050Baxter Healthcare CorporationJEA
Z-0213-2025Class IIBaxter Operating Table TruSystem 7000 (dV), Product code REF 1841049Baxter Healthcare CorporationJEA
Z-0212-2025Class IIBaxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048Baxter Healthcare CorporationJEA
Z-0221-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD08R-AP58X-000 8-Contact 1.12mm (A style)...AD-Tech Medical Instrument Corp.GZL
Z-0220-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style)...AD-Tech Medical Instrument Corp.GZL
Z-0219-2025Class IIAD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style)...AD-Tech Medical Instrument Corp.GZL
Z-0211-2025Class IIBaxter Operating Table TruSystem 7000, Product code REF 1841046Baxter Healthcare CorporationJEA
Z-0210-2025Class IIBaxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF...Baxter Healthcare CorporationGDC
Z-0498-2025Class IIBrand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus...OLYMPUS Corporation of the AmericasFDS
Z-0372-2025Class IIMedtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and...Medtronic NeuromodulationLGW
Z-0287-2025Class IIAmericot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the...American Surgical Company, LLCHBA
Z-0268-2025Class IINihon Kohden Adult Ear Clip SpO2 Sensor, 1.5 meter Model 809030007 Reusable SpO2 Ear...Nihon Kohden America IncDQA
Z-0267-2025Class IINihon Kohden Adult/Pediatric Forehead Disposable SpO2 Sensor, 0.9m Model 809030006 Disp...Nihon Kohden America IncDQA
Z-0223-2025Class IIA1CNow+ Multi-Test HbA1c System consists of (1) a semi-disposable plastic-encased device...Polymer Technology SystemsLCP
Z-0228-2025Class IIa. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P7900B000001...Baxter Healthcare CorporationFNL
Z-0068-2027NovaSeq 6000Dx including DRAGEN Server, Catalog Number: 20068232; Illumina DRAGEN...Illumina, Inc.PFF
Z-0521-2025Class IIBrand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle...MicroSurgical Technology IncHNF
Z-0362-2025Class IIThe IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in...Topcon Healthcare, Inc.NFJ
Z-0285-2025Class IISaphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally...Zimmer GmbHGEI
Z-0284-2025Class IICartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic...Canon Medical Systems USA, Inc.KPS
Z-0138-2025Class IIQuantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 &...Mckesson Medical-Surgical Inc. Corporate OfficeJJW
Z-0311-2025Class IIMEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01Datascope Corp.DSP
Z-0231-2025Class IIClariTEE Probe- Miniature transesophageal echo ultrasound probe for use with ImaCor...IMACOR, IncITX
Z-0261-2025Class IIAmbu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog...Ambu Inc.CBI
Z-0208-2025Class IPhasitron5 Breathing Circuit (P5-10, P5-HC, P5-UC-10). component of Intrapulmonary...Percussionaire Corp.NHJ
Z-0045-2025Class IICheck-Flo Performer Introducer Set, Reference Part Number RCF-5.0-35-45-J, Order Number...Cook IncorporatedDYB
Z-0117-2025Class IIThe Graft Tube is an optional instrument which, as designed, can be filled with flowable...Spineology, Inc.LXH
Z-1437-2026Class IIOlympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;OLYMPUS Corporation of the AmericasGCP
Z-0351-2025Class IIBrand Name: Olympus Product Name: Cystoscope Outer Sheath Model/Catalog Number...OLYMPUS Corporation of the AmericasGCP
Z-0258-2025Class III17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro...DRG International, Inc.JLX
Z-0225-2025Class IIEZDilate Wire Guided Balloon- Indicated for use in adult and adolescent (> 12 years)...OLYMPUS Corporation of the AmericasFGE
Z-0054-2025Class IIMEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR...Integra LifeSciences CorporationFRO
Z-0005-2025Class IZ-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version...Zyno Medical LLC.FRN
Z-0288-2025Class IIIiotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the...Iotamotion IncQQH
Z-0234-2025Class IIAbbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF...Abbott Molecular, Inc.QEP
Z-0233-2025Class IIAbbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF...Abbott Molecular, Inc.MAQ
Z-0046-2025Class IWelch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior carton codes...Baxter Healthcare CorporationCBK
Z-0026-2025Class IIBD Synapsys Informatics Solution with software versions: 4.20, 4.30, 5.10, 5.20 and...Becton Dickinson & CoJQP
Z-0364-2025Class IIBrand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access...OLYMPUS Corporation of the AmericasKNY
Z-0137-2025Class IISynchroMed II Infusion Pump. Product Number: 8637-20Medtronic NeuromodulationLKK
Z-3245-2024Class IILINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number...Waldemar Link GmbH & Co. KG (Corp. Hq.)LXH
Z-0024-2025Class IIiCast Covered Stent, 6MMx16MMx120CM, Model Number 42616Atrium Medical CorporationPRL
Z-0488-2025Class IIEnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU...Enchroma IncNAI
Z-0317-2025Class IIThe FLUOROspeed is intended to be used as a universal diagnostic imaging system for...Shimadzu Corporation Medical Systems DivisionJAA
Z-0316-2025Class IISONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitable for...Shimadzu Corporation Medical Systems DivisionJAA
Z-0226-2025Class IIBoston Scientific myLUX Patient Application for an Apple Mobile device, Model Number...Boston Scientific CorporationMXD
Z-0055-2025Class IIEnterprise Imaging XERO Viewer- software application used for reference and diagnostic...AGFA Healthcare Corp.LLZ
Z-0139-2025Class IITrinias unity, Digital Angiography System with Catheterization Table, Model: KS-100 This...Shimadzu Corporation Medical Systems DivisionOWB
Z-0265-2025Class IIAccess Thyroglobulin Antibody II, REF A32898, containing Instructions for Use, IFU REF...Siemens Healthcare Diagnostics Inc.JNL