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 186 of 1190
FDA device recalls, page 186 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0119-2024Class IIMEDLINE ReNewal Ligasure Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0118-2024Class IIMEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-0117-2024Class IIMEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10...MEDLINE INDUSTRIES, LP - NorthfieldNUJ
Z-2609-2023Class IILiquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215Randox Laboratories, LimitedJJY
Z-2595-2023Class IIMedline Sterile Iris Scissors Cvd/std, Ref Dynj04049MEDLINE INDUSTRIES, LP - NorthfieldJOK
Z-0073-2024Class II3T Heater Cooler System, REF: 16-02-85LivaNova Deutschland GmbHDWC
Z-2489-2023Class IIUpper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact...Accuray IncorporatedIYE
Z-2520-2023Class IIIncisive CT, software version 5.0Philips North America LLCJAK
Z-0126-2024Class IISynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EOSynCardia Systems LLCLOZ
Z-2622-2023Class IICOOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent...Halyard HealthGXD
Z-2470-2023Class IIGS70H Salus Surgical Table, Product Code 18-071-70Skytron, LLCGDC
Z-2469-2023Class IIGS70 Salus Surgical Table, Product Code 18-070-70Skytron, LLCGDC
Z-2627-2023Class IIPerifix / Epidural anesthesia set, medicatedB Braun Medical IncOGE
Z-2524-2023Class IIMagnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized...Medtronic Sofamor Danek USA IncMQV
Z-2432-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75...Datascope Corp.DSP
Z-2431-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31...Datascope Corp.DSP
Z-2434-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75...Datascope Corp.DSP
Z-2433-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31...Datascope Corp.DSP
Z-2436-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75...Datascope Corp.DSP
Z-2435-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31...Datascope Corp.DSP
Z-2487-2023Class IICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75...Datascope Corp.DSP
Z-2486-2023Class IICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31...Datascope Corp.DSP
Z-2438-2023Class ICardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75...Datascope Corp.DSP
Z-2437-2023Class ICardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31...Datascope Corp.DSP
Z-2642-2023Class IIHenke-Ject-2 part luer sterile single use syringes - used for intravenous, intramuscular...Wolf, Henke Sass, GmbHFMF
Z-2523-2023Class IIReusable distal attachments Models: MH-462, MH-463, MH-464, MH-465, MH-466, MH-483...AOMORI OLYMPUS CO., Ltd. Kuroishi SiteFDS
Z-2479-2023Class IIPASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000ISEdwards Lifesciences LLCNKM
Z-0024-2024Class IIGuider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac...Boston Scientific CorporationDQY
Z-0023-2024Class IIGuider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac...Boston Scientific CorporationDQY
Z-0022-2024Class IIGuider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac...Boston Scientific CorporationDQY
Z-0021-2024Class IIGuider Softip Guide Catheter 7F 100CM MULTI PURPOSE, Catalog number M003101470, cardiac...Boston Scientific CorporationDQY
Z-0020-2024Class IIGuider Softip Guide Catheter 6F 100CM MULTI PURPOSE, Catalog number M003101460, cardiac...Boston Scientific CorporationDQY
Z-0019-2024Class IIGuider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac...Boston Scientific CorporationDQY
Z-0018-2024Class IIGuider Softip Guide Catheter 7F PRE-SHAPED 40 100CM, Catalog number M003101430, cardiac...Boston Scientific CorporationDQY
Z-0017-2024Class IIGuider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac...Boston Scientific CorporationDQY
Z-0016-2024Class IIGuider Softip Guide Catheter 5F 90CM MULTI PURPOSE, Catalog number M003100630, cardiac...Boston Scientific CorporationDQY
Z-0015-2024Class IIGuider Softip Guide Catheter 5F PRE-SHAPED 40 90CM, Catalog number M003100620, cardiac...Boston Scientific CorporationDQY
Z-0014-2024Class IIGuider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac...Boston Scientific CorporationDQY
Z-0013-2024Class IIGuider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac...Boston Scientific CorporationDQY
Z-0012-2024Class IIGuider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac...Boston Scientific CorporationDQY
Z-0011-2024Class IIGuider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac...Boston Scientific CorporationDQY
Z-0010-2024Class IIGuider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac...Boston Scientific CorporationDQY
Z-0009-2024Class IIGuider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac...Boston Scientific CorporationDQY
Z-2522-2023Class IIOlympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the...AOMORI OLYMPUS CO., Ltd. Kuroishi SiteFDS
Z-2504-2023Class IIOlympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.OLYMPUS Corporation of the AmericasEOQ
Z-2503-2023Class IIOlympus Bronchovideoscope, Models BF-3C160.OLYMPUS Corporation of the AmericasEOQ
Z-2502-2023Class IIOlympus Bronchovideoscope, Models BF-3C40 & BF-N20.OLYMPUS Corporation of the AmericasEOQ
Z-2501-2023Class IIOlympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.OLYMPUS Corporation of the AmericasEOQ
Z-2500-2023Class IIOlympus Bronchovideoscope, Models BF-P190 & BF-XP190.OLYMPUS Corporation of the AmericasEOQ
Z-2499-2023Class IIOlympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2.OLYMPUS Corporation of the AmericasEOQ