Medical DeviceApr 10, 2024
SleepNet Mojo 2 Full Face Vented Mask, All Sizes recall — FDA Z-1353-2024
Update to contraindications and warning language due to CPAP masks containing magnets.
Class IFDA: OngoingSleepNet Corporation
April 2024 recalls — page 9
These records include useful source details for the selected month.
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) recall — FDA Z-1459-2024
The firm provided a set of specifications for the device, but some units of the device were manufactured non-compliant with the specifications. However, the firms Receiving Dept. accepted…
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTNL recall — FDA Z-1466-2024
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class IIFDA: OngoingCovidien, LP
Medical DeviceApr 10, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Constrained Humeral Liner: a) +0mm, Item Number recall — FDA Z-1417-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number recall — FDA Z-1423-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature recall — FDA Z-1402-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion STERILE BLOOD COLLECTION TUBE,10ML, Product recall — FDA Z-1430-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
NaviNetics Skull Anchor Key and Drill Kit, REF NN1215 recall — FDA Z-1478-2024
Defective Skull Anchor Key. After attachment of the single use Skull Anchor Key to the patient, the user was unable to attach the CT Localizer to perform stereotactic Imaging. Attachment of…
Class IIFDA: OngoingNavinetics Inc.
Medical DeviceApr 10, 2024
3M Company - Health Care Business 3M Tube Securement Device, Small, 1.7 IN/PO x 2.4 IN/PO recall — FDA Z-1475-2024
Manufacturing nonconformities are in some lots of the Tube Securement Device, such as the top film layer may be partially or completely missing and some devices may exhibit the appearance…
Class IIFDA: Ongoing3M Company - Health Care Business
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion STERILE #5 LARYNGEAL MIRROR(505709), Product recall — FDA Z-1432-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Wright Medical Technology stryker Infinity Resection Adjustment Block, REF 33600030, ankle recall — FDA Z-1477-2024
Stryker has identified an issue that impacts specific lots of Infinity" Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal…
Class IIFDA: OngoingWright Medical Technology, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44 recall — FDA Z-1414-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Terumo Cardiovascular Systems Cardiovascular Procedure Kits that include High Crack Check recall — FDA Z-1401-2024
Pressure relief valve included in certain lots of cardiovascular procedure kits was reportedly opening at approximately 200-300mmHg versus 400mmHg, potential myocardial tissue damage…
Class IIFDA: OngoingTerumo Cardiovascular Systems Corporation
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, LEFT, FOR CEMENTED USE ONLY, Mates recall — FDA Z-1408-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T12BTNL recall — FDA Z-1471-2024
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
Class IIFDA: OngoingCovidien, LP
Medical DeviceApr 10, 2024
Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) recall — FDA Z-1416-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
X-NAV Technologies X-Guide Handpiece Adaptor Sleeve 3, Model P010727 recall — FDA Z-1393-2024
The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect geometry in turn causes the Handpiece Adaptor to not fit onto the doctor's dental handpiece.
Class IIFDA: OngoingX-NAV Technologies, LLC
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion hook kits labeled as: a) STERILE SKIN HOOK recall — FDA Z-1435-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
MEDLINE INDUSTRIES, LP - Northfield Centurion manual surgical kits labeled as: a) STERILE recall — FDA Z-1443-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature recall — FDA Z-1403-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723 recall — FDA Z-1455-2024
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Class IIFDA: OngoingMEDLINE INDUSTRIES, LP - Northfield
Medical DeviceApr 10, 2024
SleepNet Mojo Non Vented Full Face Mask with Headgear, All Sizes recall — FDA Z-1352-2024
Update to contraindications and warning language due to CPAP masks containing magnets.
Class IFDA: OngoingSleepNet Corporation
Medical DeviceApr 10, 2024
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number recall — FDA Z-1419-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
Medical DeviceApr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, mates with 47, 50, 53 head, beta curvature recall — FDA Z-1404-2024
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did…
Class IIFDA: OngoingExactech, Inc.
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.