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 129 of 1190
FDA device recalls, page 129 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2513-2024Class IIGORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers...W. L. Gore & Associates, Inc.FTL
Z-2441-2024Class IISensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and...Siemens Medical Solutions USA, Inc.DQK
Z-2440-2024Class IISensis Vibe systems with software version VD15B in combination with AXIOM Sensis...Siemens Medical Solutions USA, Inc.DQK
Z-2439-2024Class IISensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER...Siemens Medical Solutions USA, Inc.DQK
Z-2438-2024Class IISensis Vibe systems with software version VD15B in combination with Sensis High End...Siemens Medical Solutions USA, Inc.DQK
Z-3192-2024Class IIBioPince Ultra Full Core Biopsy Instrument: REF: REF: 360-1080-01, 360-1080-02...Argon Medical Devices, IncKNW
Z-2689-2024Class IIDisposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5AStryker Sustainability SolutionsIKD
Z-2528-2024Class IIMultitom Rax -Intended to visualize anatomical structures by converting an x-ray pattern...Siemens Medical Solutions USA, Inc.OWB
Z-2527-2024Class IILUMINOS Lotus Max -Intended to visualize anatomical structures by converting an x-ray...Siemens Medical Solutions USA, Inc.OWB
Z-2526-2024Class IILuminos dRF Max- Intended to visualize anatomical structures by converting an x-ray...Siemens Medical Solutions USA, Inc.OWB
Z-2525-2024Class IILuminos Agile Max -Intended to visualize anatomical structures by converting an x-ray...Siemens Medical Solutions USA, Inc.OWB
Z-2450-2024Class IICPT Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis, used in Hip...Zimmer GmbHJDI
Z-2719-2024Class IICobra, 3-Plate EMG ET Tube, 6.0mm, REF: LTE7003PM, not made with natural rubber latex, Rx...Neurovision Medical Products IncETN
Z-2946-2024Class IIHeparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference...W. L. Gore & Associates, Inc.PRL
Z-2945-2024Class IIHeparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference...W. L. Gore & Associates, Inc.PRL
Z-2542-2024Class IIThe Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm...OLYMPUS Corporation of the AmericasGEI
Z-2541-2024Class IIThe Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm...OLYMPUS Corporation of the AmericasGEI
Z-2540-2024Class IIThe Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm...OLYMPUS Corporation of the AmericasGEI
Z-2512-2024Class IIBaxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300Baxter Healthcare CorporationGDC
Z-2511-2024Class IIIntelliVue Patient Monitor MX550 with L.x and M.x; K.x provided with L.x...Philips North America LLCMHX
Z-2510-2024Class IIIntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x...Philips North America LLCMHX
Z-2509-2024Class IIIntelliVue Patient Monitor MX450 with L.x and M.x; K.x provided with L.x...Philips North America LLCMHX
Z-2508-2024Class IIIntelliVue Patient Monitor MX400 with L.x and M.x; K.x provided with L.x...Philips North America LLCMHX
Z-3121-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldOJH
Z-3120-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldOJK
Z-3119-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: MERCY...MEDLINE INDUSTRIES, LP - NorthfieldOHM
Z-3118-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ...MEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-3117-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: KIT...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-3116-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: ANES...MEDLINE INDUSTRIES, LP - NorthfieldOKG
Z-3115-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: NICU...MEDLINE INDUSTRIES, LP - NorthfieldNSB
Z-3114-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-3113-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-3112-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO...MEDLINE INDUSTRIES, LP - NorthfieldPPB
Z-3111-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a) ENDO...MEDLINE INDUSTRIES, LP - NorthfieldNWU
Z-3110-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-3109-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-3108-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows...MEDLINE INDUSTRIES, LP - NorthfieldOFX
Z-3107-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-3106-2024Class IIMedline convenience kits containing semi-rigid suction liners labeled as follows: a)...MEDLINE INDUSTRIES, LP - NorthfieldCAI
Z-3105-2024Class IIMedline Semi-rigid suction liners labeled as follows: a) SEMI RIGID SUCTION LINER, REF...MEDLINE INDUSTRIES, LP - NorthfieldKDQ
Z-2644-2024Class IIVentana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody, REF: 790-4506, IVDVentana Medical Systems IncNJT
Z-2445-2024Class IILINK SymphoKnee Patella Sizing Template, Item Number 881-509/00Link Bio CorpHWT
Z-2452-2024Class IICapio SLIM Suture Capturing Device, 1-Pack, UPN: M0068318250. Capio SLIM Suture Capturing...Boston Scientific CorporationPWI
Z-2451-2024Class IICapio SLIM Suture Capturing Device, Box of 5, Outer Package UPN: M0068318261, Inner...Boston Scientific CorporationPWI
Z-2457-2024Class IIArctic Sun Temperature Management Systems, Name/REF: Arctic Sun STAT...Medivance Inc.DWJ
Z-0466-2025Class IIsmiths medical CADD-Solis Li-ion Rechargeable Battery Packs AC adapter, Model Number REF...Abbott MedicalMEA
Z-0018-2025Class IIENT RES, 100 ML, Non-Sterile W CLAMP & FEMALE LUER, Product Code 68-2231-28Abbott MedicalFPA
Z-0017-2025Class IIENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28Abbott MedicalFPA
Z-0016-2025Class IICADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24JPAbbott MedicalFPA
Z-0015-2025Class IICADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24JPAbbott MedicalFPA