510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK 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

59,486 records, page 444 of 1190
FDA device recalls, page 444 of 1190
Recall numberClassProductRecalling firmProduct codeInitiated
Z-1607-2020Class IIInstructions for Use and Surgical Cleaning Sterilization Protocol for Trilliant Surgical...Trilliant Surgical LLCHWC
Z-1606-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant...Trilliant Surgical LLCHWC
Z-1605-2020Class IIInstructions for Use and Surgical Cleaning and Sterilization Protocol for: (1) Trilliant...Trilliant Surgical LLCHWC
Z-3045-2018Class IIBeaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number...Becton Dickinson & CoHQP
Z-1076-2019Class IIAbbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.Abbott MedicalCGS
Z-1075-2019Class IIAbbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.Abbott MedicalCGS
Z-0488-2019Class IISedecal NOVA FA DR System. for diagnostic radiography.Sedecal S.A.MQB
Z-0068-2019Class IIRetrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia...Surge Medical Sales, LLC (dba Surge Cardiovascular)DWF
Z-3247-2018Class IIThe Shockwave S4 IVL Catheters are intended for lithotripsy-enhanced balloon dilatation...Shockwave Medical, Inc.PPN
Z-2949-2018Class IIP.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830Depuy Orthopaedics Inc.JWH
Z-1104-2019Class IIAbbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott...Abbott MedicalJJE
Z-1103-2019Class IIAbbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott...Abbott MedicalJJE
Z-1102-2019Class IIAbbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott...Abbott MedicalJJE
Z-0961-2019Class IIAlcon or Endure Ophthalmic Microscope Product Usage: Used for low magnification...Alcon LaboratoriesHRM
Z-0105-2019Class IIMultirall(TM) 200Liko Strap Gripper P/N 3136250 overhead lift for patient transfer...Liko ABFSA
Z-3200-2018Class II5.5 Fr x 40 cm double-lumen PICC Kit, Product Code CDC-44052-VPS2Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-3199-2018Class II4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen...Arrow International LLC (subsidiary of Teleflex Incorporated)LJS
Z-3174-2018Class IIAffixus Hip Fracture Nail Left 130 15 mm x 360 mm, Item Number: 814615360Zimmer GmbHHSB
Z-3173-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 460 mm, Item Number: 814613460Zimmer GmbHHSB
Z-3172-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 440 mm, Item Number: 814613440Zimmer GmbHHSB
Z-3171-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 420 mm, Item Number: 814613420Zimmer GmbHHSB
Z-3170-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 400 mm, Item Number: 814613400Zimmer GmbHHSB
Z-3169-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 380 mm, Item Number: 814613380Zimmer GmbHHSB
Z-3168-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 360 mm, Item Number: 814613360Zimmer GmbHHSB
Z-3167-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 340 mm, Item Number: 814613340Zimmer GmbHHSB
Z-3166-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 320 mm, Item Number: 814613320Zimmer GmbHHSB
Z-3165-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 300 mm, Item Number: 814613300Zimmer GmbHHSB
Z-3164-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 280 mm, Item Number: 814613280Zimmer GmbHHSB
Z-3163-2018Class IIAffixus Hip Fracture Nail Left 130 13 mm x 260 mm, Item Number: 814613260Zimmer GmbHHSB
Z-3162-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 460 mm, Item Number: 814611460Zimmer GmbHHSB
Z-3161-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 440 mm, Item Number: 814611440Zimmer GmbHHSB
Z-3160-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 420 mm, Item Number: 814611420Zimmer GmbHHSB
Z-3159-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 400 mm, Item Number: 814611400Zimmer GmbHHSB
Z-3158-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 380 mm, Item Number: 814611380Zimmer GmbHHSB
Z-3157-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 360 mm, Item Number: 814611360Zimmer GmbHHSB
Z-3156-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 340 mm, Item Number: 814611340Zimmer GmbHHSB
Z-3155-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 320 mm, Item Number: 814611320Zimmer GmbHHSB
Z-3154-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 280 mm, Item Number: 814611280Zimmer GmbHHSB
Z-3153-2018Class IIAffixus Hip Fracture Nail Left 130 11 mm x 260 mm, Item Number: 814611260Zimmer GmbHHSB
Z-3152-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 460 mm, Item Number: 814609460Zimmer GmbHHSB
Z-3151-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 420 mm, Item Number: 814609420Zimmer GmbHHSB
Z-3150-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 400 mm, Item Number: 814609400Zimmer GmbHHSB
Z-3149-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 360 mm, Item Number: 814609360Zimmer GmbHHSB
Z-3148-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 320 mm, Item Number: 814609320Zimmer GmbHHSB
Z-3147-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 280 mm, Item Number: 814609280Zimmer GmbHHSB
Z-3146-2018Class IIAffixus Hip Fracture Nail Left 130 9 mm x 260 mm, Item Number: 814609260Zimmer GmbHHSB
Z-3145-2018Class IIAffixus Hip Fracture Nail Right 130 15 mm x 440 mm, Item Number: 814515440Zimmer GmbHHSB
Z-3144-2018Class IIAffixus Hip Fracture Nail Right 130 15 mm x 400 mm, Item Number: 814515400Zimmer GmbHHSB
Z-3143-2018Class IIAffixus Hip Fracture Nail Right 130 15 mm x 360 mm, Item Number: 814515360Zimmer GmbHHSB
Z-3142-2018Class IIAffixus Hip Fracture Nail Right 130 15 mm x 320 mm, Item Number: 814515320Zimmer GmbHHSB