Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c recall — FDA Z-1356-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Monthly breakdown
2019 recalls by month
Select a month to review the recall records reported during that period.
December 2019321 records · 4 categoriesNovember 2019597 records · 4 categoriesOctober 2019525 records · 4 categoriesSeptember 2019268 records · 4 categoriesAugust 2019505 records · 4 categoriesJuly 2019680 records · 4 categoriesJune 2019445 records · 4 categoriesMay 2019396 records · 4 categoriesApril 2019242 records · 4 categoriesMarch 2019250 records · 4 categoriesFebruary 2019381 records · 4 categoriesJanuary 2019142 records · 4 categories
2019 recalls — page 147
Records are ordered by the best available source date.
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile recall — FDA Z-1332-2019
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP, SpO2, Product Number 863071 recall — FDA Z-1319-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Shippert Medical Technologies Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile recall — FDA Z-1330-2019
The pouch integrity of the sterile product can't be assured without a visual examination due to possibly containing a cut or hole in the pouch.
Class IIFDA: CompletedShippert Medical Technologies
Medical DeviceMay 22, 2019
Siemens Medical Solutions USA Artis Q recall — FDA Z-1342-2019
In affected Artis systems the movement of the floating tabletop may be blocked after a collision sensor has been activated during system movement.
Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Curved Intraluminal Staplers, 25 mm diameter, Model CDH25A The Ethicon recall — FDA Z-1268-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Abbott Laboratories Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus recall — FDA Z-1362-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Compass Health Brands MediPress pneumatic compression system Full Leg (Long)-Segmental recall — FDA Z-1346-2019
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class IIFDA: TerminatedCompass Health Brands (Corporate Office)
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon recall — FDA Z-1269-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The recall — FDA Z-1275-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
R82 A/S Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00 recall — FDA Z-1315-2019
Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.
Class IIFDA: TerminatedR82 A/S
Medical DeviceMay 22, 2019
Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX recall — FDA Z-1327-2019
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Class IIFDA: TerminatedPENTAX of America Inc.
Medical DeviceMay 22, 2019
Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX recall — FDA Z-1326-2019
Incorrect default dose and dose increments may be transmitted to the controller if the catheter RFID tag is not correct or is not being correctly or completely readable by the controller.
Class IIFDA: TerminatedPENTAX of America Inc.
Medical DeviceMay 22, 2019
Compass Health Brands MediPress pneumatic compression system Full Leg (Medium)-Segmental recall — FDA Z-1344-2019
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class IIFDA: TerminatedCompass Health Brands (Corporate Office)
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A recall — FDA Z-1272-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon recall — FDA Z-1267-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI recall — FDA Z-1337-2019
The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.
Class IIFDA: TerminatedTerumo Cardiovascular Systems Corporation
Medical DeviceMay 22, 2019
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage recall — FDA Z-1366-2019
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
Class IIFDA: TerminatedArrow International Inc.
Medical DeviceMay 22, 2019
Compass Health Brands MediPress pneumatic compression system Full Leg (Short)-Segmental recall — FDA Z-1347-2019
Product design change did not receive proper premarket clearance and lacks a 510 (k)
Class IIFDA: TerminatedCompass Health Brands (Corporate Office)
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074 recall — FDA Z-1322-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The recall — FDA Z-1277-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
Medical DeviceMay 22, 2019
Philips SureSigns VS3 NBP, SpO2, Temp, Product Number 863073 recall — FDA Z-1321-2019
System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute.
Class IIFDA: OngoingPhilips North America, LLC
Medical DeviceMay 22, 2019
Abbott Laboratories ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The recall — FDA Z-1359-2019
Devices were delivered without the required dry ice.
Class IIIFDA: TerminatedAbbott Laboratories
Medical DeviceMay 22, 2019
Ethicon Endo-Surgery Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A recall — FDA Z-1274-2019
The staplers may have an insufficient firing stroke to break the washer and completely form staples.
Class IFDA: CompletedEthicon Endo-Surgery Inc.
About the 2019 recall archive
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.