Medical DeviceApr 28, 2021
Welch Allyn Inc Mortara Surveyor S12/S19 Bedside Patient Monitor, with AM12M Acquisition recall — FDA Z-1484-2021
Devices do not meet IEC 60601-2-27 requirements as labeled.
Class IIFDA: TerminatedWelch Allyn Inc Mortara
Monthly breakdown
2021 recalls by month
Select a month to review the recall records reported during that period.
December 2021194 records · 4 categoriesNovember 2021210 records · 4 categoriesOctober 2021342 records · 4 categoriesSeptember 2021300 records · 4 categoriesAugust 2021279 records · 4 categoriesJuly 2021251 records · 4 categoriesJune 2021361 records · 4 categoriesMay 2021226 records · 4 categoriesApril 2021279 records · 4 categoriesMarch 2021241 records · 4 categoriesFebruary 2021320 records · 4 categoriesJanuary 2021226 records · 4 categories
2021 recalls — page 93
Records are ordered by the best available source date.
Medical DeviceApr 28, 2021
Siemens Healthcare Diagnostics BCS XP System: Multipurpose system for in vitro coagulation recall — FDA Z-1435-2021
Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD Manifold rotator (Component): a. 250 2 GANG MANIFOLD ROTATOR, OFF HANDLE recall — FDA Z-1476-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD LogiCal Left Heart Kit, Model Number M20553. for blood pressure recall — FDA Z-1473-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD LogiCal Monitoring Set, Model Number DPS564898. for blood pressure recall — FDA Z-1470-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD Stopcock rotator (Component): a. 1050 STOPCOCK ROTATOR, OFF HANDLE, Model recall — FDA Z-1477-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
Heartware Instructions for Use and Patient Manual for HeartWare HVAD System recall — FDA Z-1469-2021
IFU and Patient Manual updated to describe Expected Alarm Duration. The Instructions for Use (IFU) is being updated to advise clinicians that alarms that resolve after a very short period…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD Left Heart Kit, Model Number M20268. for blood pressure monitoring recall — FDA Z-1472-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
Medical DeviceApr 28, 2021
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue # recall — FDA Z-1467-2021
AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the device.…
Class IIFDA: TerminatedAngiodynamics Inc. (Navilyst Medical Inc.)
Medical DeviceApr 28, 2021
BIOTRONIK Ilestro 7 VR-T, DF-1, REF 383578, UDI: 04035479125349 - Product Usage: intended to recall — FDA Z-1443-2021
There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
Class IIFDA: TerminatedBIOTRONIK Inc.
Medical DeviceApr 28, 2021
Heartware Instructions for Use and Patient Manual for HeartWare HVAD System recall — FDA Z-1438-2021
IFU and Patient Manual updated to describe HVAD Controller Connection Verification. The labeling is being corrected to reflect the actual verified behavior of a successful connector to the…
Class IIFDA: OngoingHeartware, Inc.
Medical DeviceApr 28, 2021
Smiths Medical ASD Tubing with male luer lock adapter (Component) a. 76 cm, REF 601280 b. recall — FDA Z-1480-2021
Specific lots of Medex High Pressure Adaptors, Rotators, Manifolds, Stopcocks and Tubing and Medex LogiCal Kits may have been manufactured with insufficient or incomplete welds. These are…
Class IIFDA: TerminatedSmiths Medical ASD Inc.
FoodApr 28, 2021
Real Water packed in 16.9 oz., 1 Liter, 1.5 Liter, 1-Gallon and 5-Gallon recall — FDA F-0481-2021
FDA was notified of cases of acute liver failure after consumption of Real Water
Class IFDA: OngoingReal Water, Inc.
FoodApr 28, 2021
Jansala & Foods Thai Home brand Green Curry Paste packaged in glass jars recall — FDA F-0440-2021
Elevated water activity level in shelf-stable products.
Class IIIFDA: TerminatedJansala & Foods LLC
FoodApr 28, 2021
Avanti Frozen Foods Private 365 Whole Foods Market Farm Raised Cooked Shrimp 2 lbs/Ready recall — FDA F-0437-2021
One lot of uncooked shrimp was inadvertently packaged as cooked shrimp.
Class IIIFDA: TerminatedAvanti Frozen Foods Private Limited
FoodApr 28, 2021
Jansala & Foods Thai Home brand Red Curry Paste packaged in glass jars recall — FDA F-0441-2021
Elevated water activity level in shelf-stable products.
Class IIIFDA: TerminatedJansala & Foods LLC
FoodApr 28, 2021
Jansala & Foods Thai Home brand Mussaman Curry Paste packaged in glass jars recall — FDA F-0444-2021
Elevated water activity level in shelf-stable products.
Class IIIFDA: TerminatedJansala & Foods LLC
FoodApr 28, 2021
Jansala & Foods Thai Home brand Yellow Curry Paste packaged in glass jars recall — FDA F-0442-2021
Elevated water activity level in shelf-stable products.
Class IIIFDA: TerminatedJansala & Foods LLC
FoodApr 28, 2021
Real Water concentrate recall — FDA F-0482-2021
FDA was notified of cases of acute liver failure after consumption of Real Water
Class IFDA: OngoingReal Water, Inc.
FoodApr 28, 2021
RISE BAKING COMPANY Dawn Food Products,8 3 Layer Cookies and Creme Cake , 35 oz recall — FDA F-0453-2021
Undeclared allergen on label. The product label does not list Hazelnut .
Class IFDA: TerminatedRISE BAKING COMPANY
FoodApr 28, 2021
RISE BAKING COMPANY Dawn Food Products, 7 2 Layer Vanilla Bean Waterfall Cake, 35 recall — FDA F-0452-2021
Undeclared allergen on label. The product label does not list Hazelnut.
Class IFDA: TerminatedRISE BAKING COMPANY
FoodApr 28, 2021
Reser's Fine Foods Freshness Guaranteed Macaroni Salad Amish, item # 579284 recall — FDA F-0454-2021
Undeclared Wheat and/or Egg. The bottom label of Macaroni Salad Amish was mis-labeled as Red Potatoes salad or Baked Beans. The label of the Red Potatoes salad declares EGG only but does…
Class IIFDA: TerminatedReser's Fine Foods, Inc.
FoodApr 28, 2021
Jansala & Foods Thai Home brand Satay Peanut Sauce packaged in glass jars recall — FDA F-0445-2021
Elevated water activity level in shelf-stable products.
Class IIIFDA: TerminatedJansala & Foods LLC
FoodApr 28, 2021
Mountain West Mothers' Milk Bank 3 fluid ounce BPA free plastic bottles, embossed with recall — FDA F-0460-2021
Foreign object found in bottle.
Class IIFDA: TerminatedMountain West Mothers' Milk Bank Inc.
About the 2021 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.