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 76 of 1190
FDA device recalls, page 76 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-2153-2025Class IIMedline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as...MEDLINE INDUSTRIES, LP - NorthfieldLRO
Z-2157-2025Class IIBridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9%...Bridge to Life LtdKDN
Z-2152-2025Class IIEstrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of...Siemens Healthcare Diagnostics Inc.CGF
Z-2163-2025Class IIACUVUE OASYS MAX 1-Day MULTIFOCALJohnson & Johnson Vision Care, Inc.LPL
Z-2148-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly...Encore Medical, LPLPH
Z-2147-2025Class IIBrand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly...Encore Medical, LPLPH
Z-2336-2025Class IIEstrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA is an in vitro...IMMUNOTECH s.r.o.CGF
Z-2073-2025Class IIVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP...Ortho-Clinical Diagnostics, Inc.DJG
Z-2263-2025Class IIROBOTIC URO/GYN PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2262-2025Class IIROBOTIC PROSTATECTOMY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2261-2025Class IIPARTIAL NEPHRECTOMY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2260-2025Class IIPARTIAL NEPHRECTOMY - ROBOTIC. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2259-2025Class IIPACK GENERAL ROBOTIC. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2258-2025Class IIMAJOR THORACOSCOPY BASIN. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2257-2025Class IILAVH PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-2256-2025Class IILAPAROSCOPY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2255-2025Class IILAPAROSCOPIC PROSTATECTOMY. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2254-2025Class IILAPAROSCOPIC GYN. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2253-2025Class IILAP CHOLE PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2252-2025Class IIHVI CARDIAC ROBOT PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-2251-2025Class IIGYN ROBOTIC PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-2250-2025Class IIGYN LAPAROSCOPY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-2249-2025Class IIGS ENDOSCOPY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2248-2025Class IIGENERAL ROBOTIC PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-2247-2025Class IIGENERAL LAPAROSCOPY TRAY. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2246-2025Class IIGEN LAPAROSCOPY PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2245-2025Class IIDAVINCI UROLOGY. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2244-2025Class IIDAVINCI TRUCUSTOM BUNDLE. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2243-2025Class IIDA VINCI PACK URO/PROSTATE. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2242-2025Class IICT DAVINCI. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OKV
Z-2241-2025Class IICARDIAC ROBOT PACK. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305OEZ
Z-2240-2025Class IILAPAROSCOPIC TRAY. Medical convenience kit.Avid Medical, Inc. a Medical Action Ind. Company 305LRO
Z-2219-2025Class IIASPRIRE Cristalle Mammography System (cleared under K212873) installed with the ASPIRE...FUJIFILM Healthcare Americas CorporationOTE
Z-2137-2025Class IIEndosee System Convenience Kit with IV Tube. Model Number: ES-TRAY-IV. Endosee System...CooperSurgical, Inc.HIB
Z-2136-2025Class IIEndosee System Convenience Kit. Model Number: ES-TRAY. Endosee System Convenience KitCooperSurgical, Inc.HIB
Z-2135-2025Class IIHSG Procedure Tray. Model Number: 6050T. The HSG Procedure Tray is for use in...CooperSurgical, Inc.HIB
Z-2012-2025Class IICaphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32...Recordati Rare Diseases Inc.LFD
Z-2191-2025Class IIBostonSight PROSE Lens.BOSTON FOUNDATION for SIGHT/BostonSight TECHHQD
Z-0287-2026Class IISM_40HF_BDC3, Mobile X-ray systemSedecal S.A.IZL
Z-0286-2026Class IISM_40HF_BDC, Mobile X-ray systemSedecal S.A.IZL
Z-0285-2026Class IISM_40HF_B_D_VIR3.004, Mobile X-ray systemSedecal S.A.IZL
Z-0284-2026Class IISM_40HF_B_D_VIR3, Mobile X-ray systemSedecal S.A.IZL
Z-0283-2026Class IISHIMADZU RF.004, Mobile X-ray systemSedecal S.A.IZL
Z-0282-2026Class IISED URS LP, Mobile X-ray systemSedecal S.A.IZL
Z-0281-2026Class IIRADPRO MOBILE, Mobile X-ray systemSedecal S.A.IZL
Z-0280-2026Class IIModel Number SM-40HF-B-D-C; 40KW70CDEMO.005, Mobile X-ray systemSedecal S.A.IZL
Z-0279-2026Class IIModel Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray systemSedecal S.A.IZL
Z-0278-2026Class IIModel Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemSedecal S.A.IZL
Z-0277-2026Class IIModel Number SM-40HF-B-D-C; 40KW, Mobile X-ray systemSedecal S.A.IZL
Z-0276-2026Class IIModel Number SM-40HF-B-D-C; 40KW CANON READY.005, Mobile X-ray systemSedecal S.A.IZL