FoodJun 28, 2023
Aquamar Kanimi Easy Roll Crab Flavored Seafood Shred Style 91406 VCM recall — FDA F-0991-2023
Product found to contain undeclared wheat and eggs
Class IFDA: TerminatedAquamar Inc.
June 2023 recalls — page 7
These records include useful source details for the selected month.
FoodJun 28, 2023
Aquamar Kanimi Crab Flavored Seafood Fancy Shred Style 92410 recall — FDA F-0992-2023
Product found to contain undeclared wheat and eggs
Class IFDA: TerminatedAquamar Inc.
FoodJun 28, 2023
ASK Foods Wegmans Penne Rigate Mozzarella Salad Net Wt 30 OZ recall — FDA F-0998-2023
Undeclared milk allergen
Class IIFDA: TerminatedASK Foods Inc.
FoodJun 28, 2023
Aquamar Miyako Select Shredded Crab Meat Keep Refrigerated #1485 recall — FDA F-0990-2023
Product found to contain undeclared wheat and eggs
Class IFDA: TerminatedAquamar Inc.
DrugJun 28, 2023
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules recall — FDA D-0893-2023
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5…
Class IFDA: TerminatedThe Harvard Drug Group LLC dba Major Pharmaceuticals…
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 recall — FDA Z-1911-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only recall — FDA Z-1916-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Vyaire Medical bellavista 1000 Ventilator, Catalogue Number 301.100.030 recall — FDA Z-1966-2023
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive…
Class IIFDA: CompletedVyaire Medical
Medical DeviceJun 21, 2023
Vyaire Medical bellavista 1000e Ventilator, Catalogue Number 301.100.130 recall — FDA Z-1967-2023
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive…
Class IIFDA: CompletedVyaire Medical
Medical DeviceJun 21, 2023
Howmedica Osteonics Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026 recall — FDA Z-1921-2023
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
Class IIFDA: OngoingHowmedica Osteonics Corp.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE recall — FDA Z-1918-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
New Standard Device 'n'-Hole Post which is a component of the Revolution External Fixation recall — FDA Z-1824-2023
The threads on posts stripping out when tensioned during application process.
Class IIFDA: OngoingNew Standard Device Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 recall — FDA Z-1908-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Boston Scientific Neuromodulation Driver Instrument, part of the Superion Indirect recall — FDA Z-1972-2023
Pending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause driver instrument tip breaks, which may…
Class IIFDA: OngoingBoston Scientific Neuromodulation Corporation
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 recall — FDA Z-1909-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508 recall — FDA Z-1914-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992507 recall — FDA Z-1913-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
NOXBOX recall — FDA Z-1667-2023
Device may experience malfunctions due to misalignment of the check valve in the manifold. If the device fails, there is a risk of nitric oxide leak, oxygen gas leak, or earlier cylinder…
Class IFDA: TerminatedNOXBOX LTD
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992208 recall — FDA Z-1910-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE recall — FDA Z-1920-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Ossur H / F Icelock 125 Ratchet, REF: L-125000 recall — FDA Z-1906-2023
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for…
Class IIFDA: OngoingOssur H / F
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506 recall — FDA Z-1912-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Merit Medical Systems Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE recall — FDA Z-1919-2023
There is a potential that valve assemblies will not open. preventing fluid from draining.
Class IIFDA: OngoingMerit Medical Systems, Inc.
Medical DeviceJun 21, 2023
Datascope Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55 recall — FDA Z-1907-2023
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
Class IIIFDA: OngoingDatascope 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.