Medical DeviceNov 9, 2016
Unomedical As AC TenderLink 13/30 10 pcs recall — FDA Z-0357-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Latest records
Latest recalls — page 1769
The newest recall records with useful source details are listed here.
Medical DeviceNov 9, 2016
Unomedical As Comfort 5+5 Pack w/110cm Tube & 17mm Cann recall — FDA Z-0358-2017
Tubing detachment
Class IIFDA: TerminatedUnomedical As
Medical DeviceNov 9, 2016
Maquet Cardiovascular Us Sales Heater Cooler Unit Usage: The Heater-Cooler Unit (HCU 30) recall — FDA Z-0348-2017
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
Class IIFDA: TerminatedMaquet Cardiovascular Us Sales, LLC
Medical DeviceNov 9, 2016
Mindray DS USA, Inc. dba Mindray TD60 display Telemetry Transmitter, SHENZHEN Mindray recall — FDA Z-0321-2017
Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not…
Class IIFDA: TerminatedMindray DS USA, Inc. dba Mindray North America
Medical DeviceNov 9, 2016
Battle Creek Equipment Co Model 055: Thermophore Classic, Professional Quality, Deep-Heat recall — FDA Z-0349-2017
Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
Class IIFDA: TerminatedBattle Creek Equipment Co.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/ST XF/6FR/100 cm recall — FDA Z-0343-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Smith & Nephew TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038 recall — FDA Z-0351-2017
Some Bipolar shells were manufactured with an out of specification retainer groove.
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceNov 9, 2016
Medtronic Navigation Visualase Body Accessory Kit PN 020-3000 recall — FDA Z-0323-2017
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the…
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER MPXF 5F 100CM recall — FDA Z-0339-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/MP XF/6FR/90CM recall — FDA Z-0336-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/ST XF/8FR/90CM recall — FDA Z-0337-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Azer Scientific Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 recall — FDA Z-0329-2017
Out of Specification Microbiological test results
Class IIFDA: TerminatedAzer Scientific, Inc.
Medical DeviceNov 9, 2016
Medtronic Navigation Visualase Visualization Stylets PN 020-2301 recall — FDA Z-0322-2017
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the…
Class IIFDA: TerminatedMedtronic Navigation, Inc.
Medical DeviceNov 9, 2016
Smith & Nephew TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041 recall — FDA Z-0350-2017
Some Bipolar shells were manufactured with an out of specification retainer groove.
Class IIFDA: TerminatedSmith & Nephew, Inc.
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/MP XF/8FR/100 cm recall — FDA Z-0334-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/40 DEG XF/6FR/100 cm recall — FDA Z-0340-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
Medical DeviceNov 9, 2016
Stryker Neurovascular Guider Softip XF; GUIDER/40DEG XF/7FR/90CM recall — FDA Z-0333-2017
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Class IIFDA: TerminatedStryker Neurovascular
FoodNov 9, 2016
Oasis Foods Co Garden Harvest Buttermilk Ranch, Net contents: 1 GAL recall — FDA F-0381-2017
Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy…
Class IIIFDA: TerminatedOasis Foods Co
FoodNov 9, 2016
Oasis Foods Co Select Recipe Buttermilk Ranch Dressing, Net contents: 1 GAL recall — FDA F-0380-2017
Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy…
Class IIIFDA: TerminatedOasis Foods Co
FoodNov 9, 2016
Vitalicious Acquisition VitaTops Apple Crumb, NET WT recall — FDA F-0370-2017
The affected lots of VitaTops Apple Crumb contain undeclared milk.
Class IFDA: TerminatedVitalicious Acquisition
FoodNov 9, 2016
JJBL The Most Awesome Chocolate Bar Ever, Net wt recall — FDA F-0321-2017
The Most Awesome Chocolate Bar Ever is recalled due to undeclared wheat.
Class IIFDA: TerminatedJJBL LLC
FoodNov 9, 2016
Le Petit Belge BELGIAN BOYS MINI PANCAKES, NET WT recall — FDA F-0310-2017
The product/lot contains undeclared milk.
Class IFDA: TerminatedLe Petit Belge
FoodNov 9, 2016
Osage Gardens Organic 2oz Micro Greens recall — FDA F-0375-2017
Osage Gardens announces a voluntary recall of Organic 2oz Micro Greens due to a positive test for Salmonella.
Class IFDA: TerminatedOsage Gardens, Inc.
FoodNov 9, 2016
Glenn Wayne Wholseale Bakery 7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY recall — FDA F-0373-2017
The finished cookie product may contain undeclared peanuts.
Class IFDA: TerminatedGlenn Wayne Wholseale Bakery Inc.
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