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 31 of 1187
FDA device recalls, page 31 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1847-2026Class IIMedline Kits: 1) HYSTEROSCOPY PACK, Model Number: DYNJ48399C; 2) SLING PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOJF
Z-1846-2026Class IIMedline Kits: 1) GYN LAPAROSCOPY PACK, Model Number: DYNJ41257FMEDLINE INDUSTRIES, LP - NorthfieldOHD
Z-1845-2026Class IIMedline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813DMEDLINE INDUSTRIES, LP - NorthfieldMLS
Z-1844-2026Class IIMedline Kits: 1) ARTHROGRAM TRAY, Model Number: DYNJ07425; 2) TOL NEURO ANGIO PACK...MEDLINE INDUSTRIES, LP - NorthfieldOJG
Z-1843-2026Class IIMedline Kits: 1) SYR CONTROL 8ML ROTATING, Model Number: DNSC89369; 2) SYRINGE 10ML...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1842-2026Class IIMedline Kits: 1) NEWBORN ADMISSION, Model Number: DYKB1038; 2) DRAINAGE TRAY, Model...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1841-2026Class IIMedline Kits: 1) BREAST PACK, Model Number: DYNJ66777DMEDLINE INDUSTRIES, LP - NorthfieldFTN
Z-1840-2026Class IIMedline Kits: 1) GENERAL LAPAROSCOPY, Model Number: CDS930027YMEDLINE INDUSTRIES, LP - NorthfieldFDE
Z-1839-2026Class IIMedline Kits: 1) ENT PACK, Model Number: DYNJ59030B; 2) ENT, Model Number: DYNJ908586C...MEDLINE INDUSTRIES, LP - NorthfieldOGR
Z-1838-2026Class IIMedline Kits: 1) HEART TRANSPLANT BIOPSY, Model Number: DYNJ37543AMEDLINE INDUSTRIES, LP - NorthfieldOFG
Z-1837-2026Class IIMedline Kits: 1) PICC TRAY, Model Number: DYNJ41648AMEDLINE INDUSTRIES, LP - NorthfieldOFF
Z-1836-2026Class IIMedline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS, Model Number: 60021775; 2) DBD-MTS...MEDLINE INDUSTRIES, LP - NorthfieldOEZ
Z-1835-2026Class IIMedline Kits: 1) CATH LAB CDS, Model Number: CDS840228F; 2) IR PACK, Model Number...MEDLINE INDUSTRIES, LP - NorthfieldOES
Z-1834-2026Class IIMedline Kits: 1) ANGIOGRAPHY PACK-LF, Model Number: DYNJQ0505M; 2) ANGIO PACK, Model...MEDLINE INDUSTRIES, LP - NorthfieldOEQ
Z-1833-2026Class IIMedline Kits: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB; 2) MANIFOLD...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1832-2026Class IIMedline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT, Model Number: DYNJ24517DMEDLINE INDUSTRIES, LP - NorthfieldOGJ
Z-1831-2026Class IIMedline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR, Model Number: DYNJSYR12CWR; 2)...MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1830-2026Class IIMedline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB, Model Number: DYNJSYR10CWRB;MEDLINE INDUSTRIES, LP - NorthfieldDXT
Z-1829-2026Class IIMedline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L...MEDLINE INDUSTRIES, LP - NorthfieldDQX
Z-1703-2026Class II2.4 VOLT(TM) TAP CORTEX SCREW TO 90MM. Part Number: 03.424.126-US.Synthes (USA) Products LLCHWX
Z-1702-2026Class II2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.Synthes (USA) Products LLCHWX
Z-1644-2026Class IIBrand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting...OLYMPUS Corporation of the AmericasGEI
Z-1643-2026Class IIBrand Name: Olympus PKS Cutting Forceps w/Cord, 5mm 24cm Product Name: PKS Cutting...OLYMPUS Corporation of the AmericasGEI
Z-1642-2026Class IIBrand Name: Olympus PKS Cutting Forceps, 5mm 33cm Product Name: PKS Cutting...OLYMPUS Corporation of the AmericasGEI
Z-1641-2026Class IIBrand Name: Olympus HALO PKS Cutting Forceps, 5mm 33cm Product Name: HALO PKS Cutting...OLYMPUS Corporation of the AmericasGEI
Z-1640-2026Class IIBrand Name: Olympus PK Cutting Forceps, 5mm 33cm Product Name: PK Cutting...OLYMPUS Corporation of the AmericasGEI
Z-1639-2026Class IIBrand Name: Olympus Everest Bipolar Cutting Forceps w/Cord, 5mm 33 cm Product Name...OLYMPUS Corporation of the AmericasGEI
Z-1638-2026Class IIBrand Name: Olympus Everest Bipolar Cutting Forceps, 5 mm 33 cm Product Name: Everest...OLYMPUS Corporation of the AmericasGEI
Z-1688-2026Class IIStryker CHROMOPHARE Softlit Ring Surgical Light System REF: CH00000001STRYKER Communications, Inc.FSY
Z-1657-2026Class IIAtellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;Siemens Healthcare Diagnostics Inc.PDJ
Z-2671-2026Class IIRadius VSM Disposable NIBP Cuff, REF: 4825, 4826Masimo CorporationMHX
Z-2670-2026Class IIRadius VSM ECG pre-connected Set, REF: 4842, 4695Masimo CorporationMHX
Z-1821-2026Class IIBrand Name: Elegance Anterior Cervical Plate Product Name: ELEGANCE 1 LEVEL CERVICAL...Clariance-SASKWQ
Z-1634-2026Class IIBrand Name: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name...AMO Puerto Rico Manufacturing, Inc.HQL
Z-1773-2026Class IIXTANT MEDICAL Xpress Pedicle Screw System Dual Lead 6.5 x 50 mm, Part Number X073-6555-DL.Xtant Medical Holdings, Inc.MNI
Z-1693-2026Class IISterile Radiology Procedure Kits, Model Number DYNDH1491BMEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-1687-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100UH SDC-110UH SDC-120UH SDC-130UH...MentorLCJ
Z-1686-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC...MentorLCJ
Z-1685-2026Class IIArtoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130R...MentorLCJ
Z-1684-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH...MentorLCJ
Z-1683-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-107MH...MentorLCJ
Z-1682-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth...MentorLCJ
Z-1681-2026Class IICPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313...MentorLCJ
Z-1637-2026Class IBlue Ventilator Adapter Module, single-patient use circuit, Product Code M07937...Baxter Healthcare CorporationNHJ
Z-1588-2026Class IHandy Solutions Neck & Shoulders Heating Pad, Number: 25607, Manufactured by Ninbo Unico...Navajo Manufacturing CompanyIRT
Z-1581-2026Class IIBrand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife...Elekta LimitedIWB
Z-1586-2026Class IIBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number...Hologic, Inc.OYB
Z-1573-2026Class IIBrand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener...Baxter Healthcare CorporationHKO
Z-1580-2026Class IICub Pediatric Crib, Model FL19HStryker MedicalFMS
Z-1589-2026Class IPurge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and...Abiomed, Inc.OZD