DrugJul 13, 2022
Enalapril Maleate Tablets, USP recall — FDA D-1179-2022
CGMP Deviations
Class IIFDA: OngoingGolden State Medical Supply Inc.
July 2022 recalls — page 13
These records include useful source details for the selected month.
DrugJul 13, 2022
Enalapril Maleate Tablets, USP recall — FDA D-1177-2022
CGMP Deviations
Class IIFDA: OngoingGolden State Medical Supply Inc.
DrugJul 13, 2022
Testosterone Cypionate Injection, USP, 200mg/ml recall — FDA D-1176-2022
CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of machinery.
Class IIFDA: TerminatedSUN PHARMACEUTICAL INDUSTRIES Inc.
VehicleJul 8, 2022
Subaru of control module (tcm/pcm/tecm) recall — NHTSA campaign 22V485000
Subaru of America, Inc. (Subaru) is recalling certain 2020-2021 Outback and Legacy vehicles. A programming error in the Transmission Control Unit (TCU) may allow the clutch to engage before…
control module (tcm/pcm/tecm)Subaru of America, Inc.
VehicleJul 7, 2022
Ford engine and engine cooling recall — NHTSA campaign 22V484000
Ford Motor Company (Ford) is recalling certain 2020-2022 Escape, 2021-2022 Lincoln Corsair, and 2022 Maverick vehicles equipped with 2.5L HEV or PHEV engines. In the event of an engine…
engine and engine coolingFord Motor Company
Medical DeviceJul 6, 2022
Atrium Firm PVC Thoracic Catheter 28French-Intended to facilitate the evacuation of air recall — FDA Z-1297-2022
Mismatch between the expiration date on the sterile barrier pouch and the expiration date on the case/shipper label. Product sterile barrier pouch label expiration date of 16SEP2024…
Class IIFDA: OngoingAtrium Medical Corporation
Medical DeviceJul 6, 2022
Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers, Model# Labeled recall — FDA Z-1296-2022
Device model and size for affected lots of Laser Fibers may be mismatched between the product's carton, immediate pouch packaging, and/or the device.
Class IIFDA: TerminatedOlympus Corporation of the Americas
Medical DeviceJul 6, 2022
RAYSEARCH LABORATORIES AB RayStation 11B recall — FDA Z-1299-2022
This notice concerns two issues found related to the display of Linear Energy Transfer (LET) in RayStation 11B including some service packs. First, when using a dose threshold for an…
Class IIFDA: TerminatedRAYSEARCH LABORATORIES AB
Medical DeviceJul 6, 2022
GE Healthcare Field replacement back up batteries distributed on or after April 1, 2019 for recall — FDA Z-1286-2022
Backup batteries can fail earlier than their estimated life.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 81234, PN: 300007367341 , Rx Only, Sterile recall — FDA Z-1302-2022
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Class IIIFDA: OngoingVolcano Corp
Medical DeviceJul 6, 2022
Haemonetics TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) recall — FDA Z-1298-2022
When the TEG 5000 Analyzer including TEG Analytical Software is used with PlateletMapping (ADP or AA) Assays and TEG Mangement Software, incorrect values of the PlateletMapping ADP or AA %…
Class IIFDA: TerminatedHaemonetics Corporation
Medical DeviceJul 6, 2022
Baxter Healthcare #1 MAC F/O LARYNGOSCOPE recall — FDA Z-1288-2022
Packaging error.
Class IIFDA: TerminatedBaxter Healthcare Corporation
Medical DeviceJul 6, 2022
Microgenics QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A recall — FDA Z-1284-2022
Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus…
Class IIFDA: OngoingMicrogenics Corporation
Medical DeviceJul 6, 2022
K2M Yukon Straight Rod 4.0 x120mm recall — FDA Z-1307-2022
Some of the rods in this lot were observed to have discoloration, later confirmed to be indication of trace amounts of inorganic phosphorous compound. This may produce a mild irritating or…
Class IIFDA: OngoingK2M, Inc.
Medical DeviceJul 6, 2022
Skytron, Div. The KMW Group GCX Channel Mounting Accessory recall — FDA Z-1309-2022
Under certain circumstances, the mounting screws may loosen or pull out from the attachment point on the Ergon 3 boom when the GCX Channel Mounting Accessory was used with the VST clamp as…
Class IIFDA: OngoingSkytron, Div. The KMW Group, Inc.
Medical DeviceJul 6, 2022
Volcano Visions PV. 035 Digital IVUS Catheter REF 88901, PN: 300005384002 Rx Only, Sterile recall — FDA Z-1301-2022
Digital IVUS catheter instructions for use ( IFU) do not contain contrainidications
Class IIIFDA: OngoingVolcano Corp
Medical DeviceJul 6, 2022
CHANGZHOU BIOMET MEDICAL DEVICES CO DVR Anatomic, Model No recall — FDA Z-1300-2022
One lot of DVRASL plates were incorrectly etched and may have been placed into kits as DVRAR or DVRASR plates
Class IIFDA: TerminatedCHANGZHOU BIOMET MEDICAL DEVICES CO., LTD.
Medical DeviceJul 6, 2022
Haemonetics TEG 5000 Functional Fibrinogen Reagent, Item No. 07-034 recall — FDA Z-1310-2022
Due to a shift in the citrated blood reference range for a normal population, the ranges stated in the IFU are changing. If the clinician relies solely on affected results in comparison to…
Class IIFDA: TerminatedHaemonetics Corporation
Medical DeviceJul 6, 2022
Baxter Healthcare NaviCare Nurse Call/Voalte Nurse Call recall — FDA Z-1306-2022
An issue has been identified with Phillips (Emergin) and Longleaf non relay (Connexall, Vocera, Cerner) wireless integrations used with NaviCare/Voalte Nurse Call, software versions 3.9.100…
Class IIFDA: OngoingBaxter Healthcare Corporation
Medical DeviceJul 6, 2022
Getinge Usa Sales VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 recall — FDA Z-1308-2022
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint…
Class IIFDA: OngoingGetinge Usa Sales Inc.
Medical DeviceJul 6, 2022
Siemens Medical Solutions USA Artis Pheno, Interventional Fluoroscopic X-Ray System, Model recall — FDA Z-1294-2022
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc.
Medical DeviceJul 6, 2022
Wright Medical Technology Stryker INFINITY Resect Guide for INBONE Talus, Size 4, Model recall — FDA Z-1291-2022
The instrument is incorrectly color coded.
Class IIFDA: OngoingWright Medical Technology, Inc.
Medical DeviceJul 6, 2022
GE Healthcare Back up batteries in Avance CS2 and Avance CS2 Pro anesthesia devices recall — FDA Z-1285-2022
Backup batteries can fail earlier than their estimated life.
Class IIFDA: OngoingGE Healthcare, LLC
Medical DeviceJul 6, 2022
Dain Technology ProudP Everyday Uroflow Tracker Software Version 1.x.x Software Version recall — FDA Z-1292-2022
Due to interference with the Live Listen feature of hearing aid or AirPods, the user's iPhone may perform automatic processing of the urination sound signal, resulting in lower urination…
Class IIFDA: TerminatedDain Technology, Inc. (Subsidiary of Soundable Health,…
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.