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 13 of 1187
FDA device recalls, page 13 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2522-2026Class IIPhilips Avalon Fetal Monitor, FM20, Part number M2702A, Part M2703APhilips North America LLCHGM
Z-2739-2026Class IIMedtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115; Cardiopulmonary...Medtronic Perfusion SystemsDWF
Z-2738-2026Class IIMedtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010...Medtronic Perfusion SystemsDWF
Z-2602-2026Class IAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low...Abiomed, Inc.DYB
Z-2859-2026Class IIAnti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw SystemInnovasis, IncNKB
Z-2915-2026Class IIGORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible...W. L. Gore & Associates, Inc.FGE
Z-2914-2026Class IIGORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible...W. L. Gore & Associates, Inc.FGE
Z-2624-2026Class IMedtronic Harmony Delivery Catheter SystemMedtronic Heart Valves DivisionNPV
Z-2625-2026Class IIIntelliCuff, Portable automatic cuff pressure controller REF: 951001Hamilton Medical AGBSK
Z-2601-2026Class IAbiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14Fr Low...Abiomed, Inc.DYB
Z-2600-2026Class IAbiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP. Impella Set Product...Abiomed, Inc.DYB
Z-2599-2026Class IAbiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP. Impella Set Product...Abiomed, Inc.DYB
Z-2858-2026Class IIBrand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear...Medical Action Industries, Inc. 306PEV
Z-2547-2026Class IIMedline Convenience Kits: 1) OPHTHALMIC PACK W/LIDO, Model Number: DYNJ57922AMEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-2546-2026Class IIMedline Convenience Kits: 1) MERCY MEDICAL CIRCUMCISION TRAY, Model Number: CIT6780; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOHG
Z-2545-2026Class IIMedline Convenience Kits: 1) L&D CONTINUOUS EPIDURAL TRAY, Model Number: PAIN1699AMEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-2544-2026Class IIMedline Convenience Kits: 1) LUMBAR PUNCTURE CHOICE, Model Number: DYNDH1215MEDLINE INDUSTRIES, LP - NorthfieldPWY
Z-2543-2026Class IIMedline Convenience Kits: 1) ARTERIAL LINE KIT, Model Number: ART890B; 2) ULTRASOUND...MEDLINE INDUSTRIES, LP - NorthfieldLRS
Z-2542-2026Class IIMedline Convenience Kits: 1) SUTURE TRAY, Model Number: SUT12260; 2) CHEST TUBE...MEDLINE INDUSTRIES, LP - NorthfieldLRP
Z-2541-2026Class IIMedline Convenience Kits: 1) PI CVC KIT 3L 7 FR 16 CM, Model Number: ECVC8520; 2) NO...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2540-2026Class IIMedline Convenience Kits: 1) SUTURING SET, Model Number: SUT13710MEDLINE INDUSTRIES, LP - NorthfieldKDD
Z-2539-2026Class IIMedline Convenience Kits: 1) IMAGING BIOPSY TRAY, Model Number: DYNDH1068; 2) BREAST...MEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-2538-2026Class IIMedline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I550BF6C...MEDLINE INDUSTRIES, LP - NorthfieldOFD
Z-2537-2026Class IIMedline Convenience Kits: 1) DYNJ0621189X, Model Number: SM RADIOLOGY-ANGIO PACK-LF; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2536-2026Class IIMedline Convenience Kits: 1) MULTIMED, 7FR, 20CM, 3L, CVC BUNDLE, Model Number: ECVC5995...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-2535-2026Class IIMedline Convenience Kits: 1) BLOCK TRAY, Model Number: DYNJRA1590MEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-2534-2026Class IIMedline Convenience Kits: 1) PAIN MGMT/ PREF W. MED NDL, Model Number: PAIN0072L; 2)...MEDLINE INDUSTRIES, LP - NorthfieldOFT
Z-2533-2026Class IIMedline Convenience Kits: 1) ARTERIAL ACCESS TRAY W/LIDOCAINE, Model Number: ART1145; 2)...MEDLINE INDUSTRIES, LP - NorthfieldCBT
Z-2622-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical...Windstone Medical Packaging, Inc.LRO
Z-2621-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical...Windstone Medical Packaging, Inc.LRO
Z-2620-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical...Windstone Medical Packaging, Inc.OGR
Z-2619-2026Class IA M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical...Windstone Medical Packaging, Inc.LRO
Z-2637-2026Class IICRE Wireguided 18-20mm 240cmBoston Scientific CorporationFDT
Z-2636-2026Class IICRE Wireguided 15-18mm 240cmBoston Scientific CorporationFDT
Z-2635-2026Class IICRE Wireguided 12-15mm 240cmBoston Scientific CorporationFDT
Z-2900-2026Class IIGEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 00055407504 00055415010 0005...Instrumentation Laboratory Co.CHL
Z-2899-2026Class IIGEM Premier 7000 with iQM3 Part Numbers: 00077407508 00077407510 00077415004 0007741500...Instrumentation Laboratory Co.CHL
Z-2634-2026Class IICRE Wireguided 10-12mm 240cmBoston Scientific CorporationFDT
Z-2633-2026Class IICRE Wireguided 8-10mm 240cmBoston Scientific CorporationFDT
Z-2632-2026Class IICRE Wireguided 6-8mm 240cmBoston Scientific CorporationFDT
Z-2631-2026Class IICRE Pro Wireguided 18-20mm 240cmBoston Scientific CorporationFGE
Z-2630-2026Class IICRE Pro Wireguided 15-18mm 240cmBoston Scientific CorporationFGE
Z-2629-2026Class IICRE Pro Wireguided 12-15mm 240cmBoston Scientific CorporationFGE
Z-2628-2026Class IICRE Pro Wireguided 10-12mm 240cmBoston Scientific CorporationFGE
Z-2627-2026Class IICRE Pro Wireguided 8-10mm 240cmBoston Scientific CorporationFGE
Z-2551-2026Class IHillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/Catalog...Baxter Healthcare CorporationNHJ
Z-2550-2026Class IHillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Catalog Number...Baxter Healthcare CorporationNHJ
Z-2549-2026Class IHillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Catalog Number...Baxter Healthcare CorporationNHJ
Z-2548-2026Class IHillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catalog Number...Baxter Healthcare CorporationNHJ
Z-2668-2026Class II4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE...Bard Access Systems, Inc.FSH