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 1 of 1187
FDA device recalls, page 1 of 1187
Recall numberClassProductRecalling firmProduct codeInitiated
Z-3306-2026NOxBOXi Nitric Oxide Delivery System. Model Number: NOXBOX-I.Noxbox LtdMRN
Z-3318-2026Evolution upgrade 1.5T amd Evolution upgrade 3.0T; Model number (REF): 1. 782116 (1.5T)...Philips North AmericaLNH
Z-3317-2026Upgrade to MR 7700; Model number (REF): 782130; Software Versions: R11, R12 and R13;Philips North AmericaLNH
Z-3316-2026Upgrade dStream; Model number (REF): 782127; Software Versions: R11, R12 and R13;Philips North AmericaLNH
Z-3315-2026SmartPath to MR 7700; Model number (REF): 1. 782178, 2. 782207; Software Versions: R11...Philips North AmericaLNH
Z-3314-2026SmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for...Philips North AmericaLNH
Z-3313-2026MR 7700; Model number (REF): 1. 782120, 2. 782153, 3. 782155, 4. 782199; Software...Philips North AmericaLNH
Z-3312-2026MR 5300; Model number (REF): 1. 782110, 2. 782152, 3. 782156, 4. 782196; Software...Philips North AmericaLNH
Z-3311-2026Ingenia Elition S and Ingenia Elition X.; Model number (REF): 1. 781357 (S), 2. 782106...Philips North AmericaLNH
Z-3310-2026Ingenia Ambition S and Ingenia Ambition X.; Model number (REF): 1. 781359 (S), 2. 782108...Philips North AmericaLNH
Z-3309-2026Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3...Philips North AmericaLNH
Z-3308-2026Ingenia 1.5T, 1.5T CX, and 1.5T S; Model number (REF): 1. 781315 (1.5T), 2. 781341...Philips North AmericaLNH
Z-3307-2026Ingenia Blue Seal SE and Blue Seal XE; Model number (REF): 1. 782185 (SE), 2. 782192...Philips North AmericaLNH
Z-3329-2026Olympus Tripp-Lite P580-025 25ft DisplayPort Cable, Model Number P580-025, an accessory...Olympus Corporation of the AmericasN/A
Z-3300-2026Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.Olympus Corporation of the AmericasHIH
Z-3299-2026Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.Olympus Corporation of the AmericasHIH
Z-3214-2026Class IImager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038...Boston Scientific CorporationDQO
Z-3243-2026Class IISmartPath to dStream for 1.5T, SmartPath to dStream for 3.0T, SmartPath to dStream for XR...Philips North America LlcLNH
Z-3242-2026Class IIMR 7700 and Upgrade to MR 7700; Model Number (REF): 1. 782120, 2. 782153, 3. 782130...Philips North America LlcLNH
Z-3241-2026Class IIMR 5300 Model Number (REF): 1. 782110, 2. 782152;Philips North America LlcLNH
Z-3240-2026Class IIName (Model Number): 1. Intera 1.5T (781195), 2. Intera 1.5T (781295), 3. Intera 1.5T...Philips North America LlcLNH
Z-3239-2026Class IIIngenia Elition S and Ingenia Elition X; Model Numbers (REF): 1. 781357(S), 2. 782106(S)...Philips North America LlcLNH
Z-3238-2026Class IIIngenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF): 1. 781342(3.0T), 2. 781377(3.0T)...Philips North America LlcLNH
Z-3237-2026Class IIIngenia Ambition S and Ingenia Ambition X; Model Numbers (REF): 1. 781359 (S), 2. 782108...Philips North America LlcLNH
Z-3236-2026Class IIIngenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF): 1. 781315(1.5T)...Philips North America LlcLNH
Z-3235-2026Class IIEvolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF): 1. 782116 (1.5T)...Philips North America LlcLNH
Z-3234-2026Class IIAchieva XR; Model Numbers (REF): 1. 781153, 2. 781253;Philips North America LlcLNH
Z-3233-2026Class IIAchieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;Philips North America LlcLNH
Z-3232-2026Class IIAchieva 1.5T, Achieva 1.5T Conversion and Achieva 1.5T Initial system; Model Numbers...Philips North America LlcLNH
Z-3220-2026Class IIMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic...Midmark CorporationMWI
Z-3219-2026Class IIMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic...Midmark CorporationMWI
Z-3218-2026Class IIMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic...Midmark CorporationMWI
Z-3217-2026Class IIMidmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic...Midmark CorporationMWI
Z-3274-2026Fisher Scientific Sure-Vue Urine hCG, Model/ Part: FHC-102/23900526; Henry Schein, Inc...Alere San Diego, Inc.JHI
Z-3273-2026Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson...Alere San Diego, Inc.JHI
Z-3272-2026Fisher Scientific Sure-Vue Serum/Urine hCG, Model/ Part: FHC-202/23900529...Alere San Diego, Inc.JHI
Z-3256-2026Class IIREF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 SeriesDeRoyal Industries IncFLL
Z-3304-2026PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635...Heraeus Medical GmbH (Dental Division)LOD
Z-3303-2026PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290...Heraeus Medical GmbH (Dental Division)MBB
Z-3302-2026PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289...Heraeus Medical GmbH (Dental Division)MBB
Z-3301-2026PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque...Heraeus Medical GmbH (Dental Division)LOD
Z-3212-2026Class IICADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes...ICU Medical, Inc.LHI
Z-3275-2026EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number...Bard Peripheral Vascular IncKNW
Z-3177-2026Class IIBrand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC...Wilson-Cook Medical Inc.QAU
Z-3271-2026McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20...Alere San Diego, Inc.JHI
Z-3226-2026Class IISeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal...Seaspine Orthopedics CorporationNKB
Z-3187-2026Class IIREF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMStryker Sustainability SolutionsNLM
Z-3186-2026Class IIREF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMStryker Sustainability SolutionsNLM
Z-3185-2026Class IIREF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MMStryker Sustainability SolutionsNLM
Z-3184-2026Class IIREF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MMStryker Sustainability SolutionsNLM