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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 149 of 1190
FDA device recalls, page 149 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1691-2024Class IIIntellis AdaptiveStim Product Number 97715, Spinal Cord StimulatorMedtronic NeuromodulationLGW
Z-1608-2024Class IINexGen CR-Flex Femoral Component, Size E and Size E Minus (E-). Component of the NexGen...Zimmer GmbHJWH
Z-1946-2024Class IINewport s N-LHP-928(j) units if sold as a laser head/power supply set, and N5-LPL-944-080...Newport CorpRFN
Z-1739-2024Class IIJackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475Medtronic, Inc.GBX
Z-1738-2024Class IIJackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601Medtronic, Inc.GBX
Z-1737-2024Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403DMedtronic, Inc.GBX
Z-1736-2024Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402DMedtronic, Inc.GBX
Z-1735-2024Class IIJackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401DMedtronic, Inc.GBX
Z-1814-2024Class IBiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbers...Respironics, Inc.MNS
Z-1813-2024Class IBiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and (OUS...Respironics, Inc.MNT
Z-1812-2024Class IBiPAP V30 Auto Ventilator, Part Number 1111178Respironics, Inc.MNS
Z-1776-2024Class IStealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the...Medtronic Navigation, IncHAW
Z-1511-2024Class IIPower Cords, marketed under the following models: a) CORD,METAL EARTH PIN...Baxter Healthcare CorporationDXN
Z-1510-2024Class IIHillrom Welch Allyn Spot Vision Screener VS100, marketed under the following models: a)...Baxter Healthcare CorporationDXN
Z-1509-2024Class IIHillrom Welch Allyn Connex ProBP 3400 Digital Blood Pressure Device, marketed under the...Baxter Healthcare CorporationDXN
Z-1534-2024Class IIPOLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503NSurgical Specialties CorpGAM
Z-1790-2024Class IIRKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic componentOssur Iceland ehf.ISW
Z-1789-2024Class IIRKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentOssur Iceland ehf.ISW
Z-1788-2024Class IIRKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic componentOssur Iceland ehf.ISW
Z-1787-2024Class IIRKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic componentOssur Iceland ehf.ISW
Z-1535-2024Class IAW-M0001 SONARMED MONITOR. Used in conjunction with SonarMed Acoustic Sensors for airway...Sonarmed, Inc.OQU
Z-1757-2024Class II5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500...Philips North America LLCIYN
Z-2714-2024Class IIMedline medical procedure kits labeled as follows: a) ARTHROSCOPY, REF DYNJ909699; b)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-2713-2024Class IIMedline medical procedure kits labeled as follows: a) C-SECTION CDS, REF CDS983998CMEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-2712-2024Class IIMedline medical procedure kits labeled as follows: a) GYN CDS, REF DYNJ905499B; b) GYN...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-2711-2024Class IIMedline medical procedure kits labeled as follows: a) BASIC NEURO, REF DYNJ909171A; b)...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-2710-2024Class IIMedline medical procedure kits labeled as follows: a) TURNOVER KIT, REF DYKC1289FMEDLINE INDUSTRIES, LP - NorthfieldOKG
Z-2709-2024Class IIMedline medical procedure kits labeled as follows: a) KIT CANISTER SUCT W 12FT, REF...MEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2708-2024Class IIMedline medical procedure kits labeled as follows: a) AAA CDS, REF CDS984011C; b) CAN...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2707-2024Class IIMedline medical procedure kits labeled as follows: a) MAJOR BREAST, REF DYNJ905004C...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-2706-2024Class IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYKE1410AMEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-2705-2024Class IIMedline medical procedure kits labeled as follows: a) ENDO KIT, REF DYK1012268E1MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-2704-2024Class IIMedline medical procedure kits labeled as follows: a) CYSTO, REF DYNJ905000D; b) ENDO...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-2703-2024Class IIMedline medical procedure kits labeled as follows: a) BASIC NASAL, REF DYNJ909932; b)...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-2702-2024Class IIMedline medical procedure kits labeled as follows: DENTAL, REF DYNJ909211AMEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-2701-2024Class IIMedline medical procedure kits labeled as follows: a) HEART ANESTHESIA SET UP, REF...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-2700-2024Class IIMedline medical procedure kits labeled as follows: a) ANESTHESIA CIRCUIT ADULT, REF...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-2699-2024Class II1,5L Med-Soft Single Liner with Solidifier, Ref Or1920pgMEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2698-2024Class II1,5L Med-Soft Liner W/ 6Mmx3m Tub. & Adult Vc, Ref Or53929MEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2697-2024Class II1,5L Med-Soft Liner W/ 6Mmx1,8m Tub. & Adult Vc, Ref Or53926MEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2696-2024Class II1500Ml Soft Liner, 1/4X6 Tbg Ns, Ref Or926kMEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2695-2024Class IILiner, Soft, Suction Canister, 1500Cc, Ref Or929kMEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2694-2024Class IILiner, Soft, Suction Canister, 1500Cc, Ref Dyndscl1500MEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-1690-2024Class IIPhilips Patient Information Center (PIC) iX Uninterruptable Power Supply (UPS): 1. APC...Philips North America LLCMHX
Z-1604-2024Class IIRedux Electrolyte Creme, Product Ref. 66-04. Highly conductive electrolyte creme.Parker Laboratories, Inc.GYB
Z-1619-2024Class II48" Lead Wires, Replacement Part Number: 1067724-4Ebi, LLCLOF
Z-1618-2024Class II20" Lead Wires, Replacement Part Number: 1067724-2Ebi, LLCLOF
Z-1617-2024Class IIBiomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated for the treatment of...Ebi, LLCLOF
Z-1616-2024Class IIBiomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated for the treatment...Ebi, LLCLOF
Z-1598-2024Class IISiemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Artis zee floor...Siemens Medical Solutions USA, Inc.OWB