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 111 of 1190
FDA device recalls, page 111 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0475-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4722Hobbs Medical, Inc.FBK
Z-0474-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718Hobbs Medical, Inc.FBK
Z-0473-2025Class IIPosi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704Hobbs Medical, Inc.FBK
Z-0472-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721Hobbs Medical, Inc.FBK
Z-0471-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716Hobbs Medical, Inc.FBK
Z-0470-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706Hobbs Medical, Inc.FBK
Z-0469-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702Hobbs Medical, Inc.FBK
Z-0468-2025Class IIPosi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720Hobbs Medical, Inc.FBK
Z-0481-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-2.Caire, Inc.CAW
Z-0480-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103.Caire, Inc.CAW
Z-0479-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101.Caire, Inc.CAW
Z-0478-2025Class IICAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1.Caire, Inc.CAW
Z-0350-2025Class IIARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004CMEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0349-2025Class IICARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003AMEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-0370-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile...Stryker Corp.GEI
Z-0369-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button...Stryker Corp.GEI
Z-0368-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch...Stryker Corp.GEI
Z-0367-2025Class IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm...Stryker Corp.GEI
Z-0366-2025Class IIStryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile...Stryker Corp.GEI
Z-0365-2025Class IIStryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed...Stryker Corp.GEI
Z-0312-2025Class ImicroTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended use is to...FHC, Inc.HAW
Z-0318-2025Class IIGE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1)...GE HealthcareLLZ
Z-0309-2025Class IIDeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06DeRoyal Industries, Inc.FDE
Z-0308-2025Class IIDeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06DeRoyal Industries, Inc.LRO
Z-0307-2025Class IIDeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06DeRoyal Industries, Inc.LRO
Z-0306-2025Class IIDeRoyal C-SECTION TRACEPACK, REF 89-9338-06DeRoyal Industries, Inc.KDD
Z-0289-2025Class IIMedtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary...Medtronic Perfusion SystemsDWF
Z-0463-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0462-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0461-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0460-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0459-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0458-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0457-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0456-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the...Maquet Cardiovascular Us Sales, LLCFQO
Z-0744-2025Class IITEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA...Limacorporate S.p.A.JDB
Z-0516-2025Class IIRENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a...Smith & Nephew Medical LtdOMP
Z-0348-2025Class IIBaxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009Baxter Healthcare CorporationFRN
Z-0282-2025Class IIsmith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N...Smith & Nephew, Inc.JWH
Z-0281-2025Class IIsmith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT...Smith & Nephew, Inc.JWH
Z-0278-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF...Smith & Nephew, Inc.JWH
Z-0277-2025Class IIsmith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF...Smith & Nephew, Inc.JWH
Z-0619-2025Class IIMEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB...Advanced Medical Solutions LimitedNAC
Z-0618-2025Class IIMcKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to...Advanced Medical Solutions LimitedNAC
Z-0617-2025Class IIHollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are...Advanced Medical Solutions LimitedNAC
Z-0552-2025Class IIIMerlin@home with the MerlinOnDemand capability Transmitter REF EX1150 Merlin@home with...Abbott MedicalNVZ
Z-0551-2025Class IIIMerlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter is intended to...Abbott MedicalNVZ
Z-0523-2025Class IIIBrand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number...Zyno Medical LLC.FRN
Z-0500-2025Class IIPrecice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x...NuVasive Specialized Orthopedics, Inc.HSB
Z-0464-2025Class IIIMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number...Siemens Healthcare Diagnostics Inc.MTF