FoodDec 25, 2019
Slade Gorton & Company GOURMET BAY Haddock with Seafood Stuffing recall — FDA F-0339-2020
Product stuffing may be contaminated with Listeria monocytogenes
Class IIFDA: TerminatedSlade Gorton & Company, Inc.
December 2019 recalls — page 3
These records include useful source details for the selected month.
DrugDec 25, 2019
Memantine Hydrochloride Extended-release Capsules, 28mg recall — FDA D-0629-2020
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class IIIFDA: TerminatedLupin Pharmaceuticals Inc.
DrugDec 25, 2019
Apothecus Pharmaceutical VCF Vaginal Contraceptive Foam, a) can, 13 applications per can recall — FDA D-0623-2020
Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
Class IIIFDA: TerminatedApothecus Pharmaceutical Corp.
VehicleDec 19, 2019
Mazda3 automatic emergency braking recall — NHTSA campaign 19V907000
Mazda North American Operations (Mazda) is recalling certain 2019-2020 Mazda3 vehicles. The Smart Brake System (SBS) can falsely detect an obstacle while driving, activating the automatic…
automatic emergency brakingMazda North American Operations
Medical DeviceDec 18, 2019
Smiths Medical ASD Medfusion Syringe Pump, Model 4000 recall — FDA Z-0610-2020
There is an anomaly in Medfusion 4000 Syringe Pump Firmware version 1.7.0 that could potentially result in loss of primary audible and visual battery alarm functionality, and interruption…
Class IFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0635-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Medtronic Navigation Passive Biopsy Needle Kit, UDI: 00643169030121 and 00643169702943 recall — FDA Z-0657-2020
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not…
Class IIFDA: OngoingMedtronic Navigation, Inc.
Medical DeviceDec 18, 2019
DePuy Mitek, Inc., a Johnson & Johnson Co Healix Knotless ADV BR 5.5 Suture Anchor recall — FDA Z-0666-2020
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE Biocomposite Material. BIOCRYL…
Class IIFDA: TerminatedDePuy Mitek, Inc., a Johnson & Johnson Co.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0645-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0638-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Medtronic Navigation Biopsy Needle FPU Kit, Product # 9736075, UDI: 00763000063108 recall — FDA Z-0659-2020
The firm has become aware that due to a manufacturing issue impacting the biopsy needle depth stop, there exist the potential that some biopsy needle depth stops, when tightened, may not…
Class IIFDA: OngoingMedtronic Navigation, Inc.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0620-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0625-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0649-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Volcano Philips Volcano FFR software used in the following systems connected to the recall — FDA Z-0674-2020
Interoperability issue that affects certain systems that use the recalled software when it is connected to specific Hemodynamic Systems (HMS).
Class IIFDA: TerminatedVolcano Corporation
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0647-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0628-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0654-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Cook CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For recall — FDA Z-0587-2020
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4…
Class IFDA: TerminatedCook Inc.
Medical DeviceDec 18, 2019
Cook CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For recall — FDA Z-0589-2020
A manufacturing error may cause the radiopaque marker bands to be too loose on certain CXC3.0 CrossCath Support Catheters (compatible with 0.014 wire guides) and too tight on certain CXC3.4…
Class IFDA: TerminatedCook Inc.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0650-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Encore Medical EMPOWR Locking Femoral Impactor , Part # 800-05-035, packaged in instrument recall — FDA Z-0611-2020
The firm has received reports/complaints concerning the breakage of the tips of the locking femoral Impactor. Additionally, if the impactor is not seated correctly on the implant prior to…
Class IIFDA: OngoingEncore Medical, Lp
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0618-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
Medical DeviceDec 18, 2019
Integra LifeSciences C7000 - CUSA Clarity Ultrasonic Tissue Ablation System recall — FDA Z-0619-2020
The 36 kHz Sterilization Tray (C7136 Rev C / 72904491 Rev A) system does not meet the Dry Time Criteria for a 30-minute drying cycle. The current CUSA Clarity Operators manual states 30…
Class IIFDA: TerminatedIntegra LifeSciences Corp.
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.