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 77 of 1190
FDA device recalls, page 77 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-0275-2026Class IIModel Number SM-40HF-B-D-C; 40KW CANON READY, Mobile X-ray systemSedecal S.A.IZL
Z-0274-2026Class IIModel Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemSedecal S.A.IZL
Z-0273-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C READY, Mobile X-ray systemSedecal S.A.IZL
Z-0272-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C EN, Mobile X-ray systemSedecal S.A.IZL
Z-0271-2026Class IIModel Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal S.A.IZL
Z-0270-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal S.A.IZL
Z-0269-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal S.A.IZL
Z-0268-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55G/60G, Mobile X-ray systemSedecal S.A.IZL
Z-0267-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemSedecal S.A.IZL
Z-0266-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C/60C, Mobile X-ray systemSedecal S.A.IZL
Z-0265-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal S.A.IZL
Z-0264-2026Class IIModel Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal S.A.IZL
Z-0263-2026Class IIModel Number SM-40HF-B-D-C; 40KW 50C, Mobile X-ray systemSedecal S.A.IZL
Z-0262-2026Class IISedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemSedecal S.A.IZL
Z-0261-2026Class IIModel Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemSedecal S.A.IZL
Z-0260-2026Class IIModel SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal S.A.IZL
Z-0259-2026Class IIModel Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal S.A.IZL
Z-0258-2026Class IIModel Number SM-40HF-B-D-C; 40KW 50G, Mobile X-ray systemSedecal S.A.IZL
Z-0257-2026Class IIModel SM-40HF-B-D-C; 40KW - CANON READY, Mobile X-ray systemSedecal S.A.IZL
Z-0256-2026Class IIModel SM-32HF-Batt; 32KW ANALOG, Mobile X-ray systemSedecal S.A.IZL
Z-0255-2026Class IIModel Number SM-32HF-B-D-C; 32KW 50G, Mobile X-ray systemSedecal S.A.IZL
Z-0254-2026Class IIModel Number SM-20HF-Batt; 20KW ANALOG, Mobile X-ray systemSedecal S.A.IZL
Z-0253-2026Class IIModel Number 40KWMOBILE3.899, Mobile X-ray systemSedecal S.A.IZL
Z-0252-2026Class IIModel Number 40KWFXPLUS-710CW.007, Mobile X-ray systemSedecal S.A.IZL
Z-0251-2026Class IIModel Number 40KWFXPLUS-710CW, Mobile X-ray systemSedecal S.A.IZL
Z-0250-2026Class IIModel Number 40KWFXPLUS.889, Mobile X-ray systemSedecal S.A.IZL
Z-0249-2026Class IIModel Number 40KWFXPLUS.005, Mobile X-ray systemSedecal S.A.IZL
Z-0248-2026Class IIModel Number 40KWFXPLUS.004, Mobile X-ray systemSedecal S.A.IZL
Z-0247-2026Class IIModel Number 40KWFXPLUS.002, Mobile X-ray systemSedecal S.A.IZL
Z-0246-2026Class IIModel Number 40KWFXPLUS, Mobile X-ray systemSedecal S.A.IZL
Z-0245-2026Class IIModel Number 40KW-FX.899, Mobile X-ray systemSedecal S.A.IZL
Z-0244-2026Class IIModel Number 40KWFX, Mobile X-ray systemSedecal S.A.IZL
Z-2190-2025Class IIBostonSight SCLERAL LensBOSTON FOUNDATION for SIGHT/BostonSight TECHHQD
Z-0243-2026Class IIMobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemSedecal S.A.IZL
Z-0242-2026Class IISedecal Mobile Digital Diagnostic X-Ray Systems; SM-40HF-B-D-KM (AeroDR X30)Sedecal S.A.IZL
Z-2123-2025Class IIVITROS Chemistry Products CHE Slides (Japan); Catalog Numbers: (1) 684 4074 (90 slides)...Ortho-Clinical Diagnostics, Inc.DIH
Z-2122-2025Class IIVITROS Chemistry Products CHE Slides; Catalog Numbers: (1) 191 4605 (300 slides), (2) 800...Ortho-Clinical Diagnostics, Inc.DIH
Z-2121-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance...Ortho-Clinical Diagnostics, Inc.DIH
Z-2120-2025Class IIBrand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance...Ortho-Clinical Diagnostics, Inc.DIH
Z-2106-2025Class IITorflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM...Boston Scientific CorporationDXF
Z-2105-2025Class IIVersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0...Boston Scientific CorporationDXF
Z-2104-2025Class IIVersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the...Boston Scientific CorporationDXF
Z-2103-2025Class IIVersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE...Boston Scientific CorporationDXF
Z-2451-2025Class IIIAkreos, SKU: AO60P0300. Akreos intraocular lensesBausch & Lomb IncorporatedHQL
Z-2485-2025Class IISuperion IDS Kit Superion Indirect Decompression System 8MM, VF...Boston Scientific Neuromodulation CorporationNQO
Z-2296-2025Class IICustom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B...Merit Medical Systems, Inc.PPD
Z-2295-2025Class IICustom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A...Merit Medical Systems, Inc.OEZ
Z-2294-2025Class IICustom Tubing Kit: REF: K04-00417, K04-00963, K04-01029Merit Medical Systems, Inc.OJA
Z-2293-2025Class IIHigh Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CMerit Medical Systems, Inc.FPK
Z-2119-2025Class IIBrand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number...Waismed Ltd.FMI