Medical device recalls
39229 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2017-06-21FDA-DeviceMedtronicClass IIBest Practice Kit, Item Numbers: 00Z2064, 00Z2150, 00Z2190, 00Z2192, 00Z2211, 00Z2212, 00Z2216, 00Z2217, 00Z2312
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- 2017-06-21FDA-DeviceMedtronicClass IISutures. BIOSYN: BIOSYN 4/0 18" VIOLET CV-25 DT, Item Number: GMJ34M
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- 2017-06-21FDA-DeviceMedtronicClass IISutures. ENDO STITCH: ENDO STITCH POLYSORB 0 48" U/D DLU SU, Item Number: 170056; ENDO STITCH POLYSORB 0 48" VIO DLU SU, Item Number: 170052; ENDO STITCH POLYSORB 2/0 48" U/D DLU SU, Item Number: 170057; ENDO STITCH POLYSORB 2/0 48" VIO DLU SU, Item Number: 170053
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- 2017-06-21FDA-DeviceMedtronicClass IISutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- 2017-06-21FDA-DeviceMedtronicClass IISutures. POLYSORB: POLSORB 0 18 U/D PRECUT 126R, Item Number: L4; POLSORB 0 18 VIO PRECUT 226T; Item Number: L14; POLSORB 0 30 VIO PRECUT 227C, Item Number: L404; POLSORB 1 18 VIO PRECUT 122J; Item Number: L15; POLSORB 1 30 VIO PRECUT 224E; Item Number: L405; POLSORB 4/0 60" REEL VIO 217T, Item Number: LL111; POLYSORB 0 18 UNDYED PRECUT, Item Number: L24; POLYSORB 0 18" UNDYED GS-21 DT, Item Number: CL14MG; POLYSORB 0 18" VIOLET PRECUT, Item Number: L27; POLYSORB 0 60 U/D REEL 203G, Item Num
Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
- 2017-06-21FDA-DeviceCook Inc.Class IIVue Optic Visualization Source, Flexor Vue Deflecting Endoscopic System, Endoscope, Fiber Optic, Supplied sterilized by ethylene oxide gas in peel-open packages
Cook Inc. is initiating a voluntary recall of the Vue Optic Visualization Source and the Flexor Vue Deflecting Endoscopic System because it was determined that the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
- 2017-06-21FDA-DeviceCook Inc.Class IICook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
Correction to the product Instructions for Use because the current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.
- 2017-06-21FDA-DeviceCook Inc.Class IIEndoscopic Introducer/Extractor
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- 2017-06-21FDA-DeviceCook Inc.Class IIClarke-Reich Laparoscopic Knot Pusher
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- 2017-06-21FDA-DeviceCook Inc.Class IIStamey Needle
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- 2017-06-21FDA-DeviceCook Inc.Class IIPereyra Ligature Carrier 75
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- 2017-06-21FDA-DeviceCook Inc.Class IIPereyra-Raz Ligature Carrier
reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- 2017-06-21FDA-DeviceApplied Medical Resources CorpClass IIKii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Due to possibility of insufficient sterilization.
- 2017-06-21FDA-DeviceCreganna Medical DevicesClass IIBoston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85300
Lack of sterility assurance.
- 2017-06-21FDA-DeviceCreganna Medical DevicesClass IIBoston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004EPTMCA85400
Lack of sterility assurance.
- 2017-06-21FDA-DeviceCreganna Medical DevicesClass IIBoston Scientific Zurpaz(TM) MEDIUM CURL, SYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USMC85100
Lack of sterility assurance.
- 2017-06-21FDA-DeviceCreganna Medical DevicesClass IIBoston Scientific Zurpaz(TM) MEDIUM CURL, ASYMMETRIC CURVE, Steerable Sheath, 8.5F (2.83mm), REF Catalog No M004USTMCA85200
Lack of sterility assurance.
- 2017-06-21FDA-DevicePhilips Electronics North America CorporationClass IIM3150 Information Center Local Database; Models: 862249, 865001, 865003, 865004, 865007, 865009, 865011, 865012, 865091, 865092, 865093, 865094, 865095, 865096, 865098, 865099, 865102, 865104, 865105, 865125, 865127. The intended use of the Information Center Software is to display physiologic waves, parameters and trends, formal data for strip recordings and printed reports and provide the secondary annunciation of alarms from other networked medical devices at a centralized location. The Info
Potential for early component failure.
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-GN67), IVD, REF 413399, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-GN04), IVD, REF 22000, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N364), IVD, REF 421693, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N363), IVD, REF 421692, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD, REF 421585, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD, REF 421573, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N357), IVD, REF 421451, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N358), IVD, REF 421441, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N356), IVD, REF 421352, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N355), IVD, REF 421351, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N354), IVD, REF 421350, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
- 2017-06-21FDA-DeviceBiomerieux IncClass IIVITEK¿ 2 Gram Negative Susceptibility card (AST-N353), IVD, REF 421297, 20 cards per carton.
The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).
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