Medical DeviceMar 18, 2026
International Life Sciences Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor recall — FDA Z-1556-2026
Augmentation devices failed bacterial endotoxin testing.
Class IIFDA: OngoingInternational Life Sciences
Latest records
Latest recalls — page 71
The newest recall records with useful source details are listed here.
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055415010 recall — FDA Z-1535-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055445004 recall — FDA Z-1541-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Trividia Health Owner's Booklets and Instructions for Use that are used with the following recall — FDA Z-1548-2026
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for…
Class IFDA: OngoingTrividia Health, Inc.
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000 PAK recall — FDA Z-1525-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000 PAK recall — FDA Z-1530-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055445008 recall — FDA Z-1542-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000 PAK recall — FDA Z-1529-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
APTUS 2.5 TriLock Screw 16mm, HD7, 1/Pkg recall — FDA Z-1549-2026
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
Class IIFDA: OngoingMedartis AG
Medical DeviceMar 18, 2026
Physio-Control PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog recall — FDA Z-1544-2026
Due to pediatric defibrillator electrode delamination
Class IIFDA: OngoingPhysio-Control, Inc.
Medical DeviceMar 18, 2026
Beckman Coulter Mishima K.K DxC 700 AU, REF: B86444, B86446 recall — FDA Z-1552-2026
A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent…
Class IIFDA: OngoingBeckman Coulter Mishima K.K.
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000 PAK recall — FDA Z-1527-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Equinoxe Ergo Ergo Modular Impactor Handle recall — FDA Z-1509-2026
Impactor handle may be missing cross-pin
Class IIFDA: OngoingExactech, Inc.
Medical DeviceMar 18, 2026
Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART recall — FDA Z-1562-2026
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18…
Class IIFDA: OngoingMedline Industries, LP
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000 PAK recall — FDA Z-1531-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055415008 recall — FDA Z-1534-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall — FDA Z-1520-2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055430008 recall — FDA Z-1538-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Model No. 00055430010 recall — FDA Z-1539-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Medical DeviceMar 18, 2026
Raz Design Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI recall — FDA Z-1498-2026
Due to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in place.
Class IIFDA: OngoingRaz Design Inc
Medical DeviceMar 18, 2026
Waldemar Link GmbH & Co. KG Endo-Model SL Connection Component incl recall — FDA Z-1511-2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceMar 18, 2026
Trividia Health Owner's Booklets and Instructions for Use that are used with the following recall — FDA Z-1547-2026
The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for…
Class IFDA: OngoingTrividia Health, Inc.
Medical DeviceMar 18, 2026
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall — FDA Z-1517-2026
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
Class IIFDA: OngoingWaldemar Link GmbH & Co. KG (Mfg Site)
Medical DeviceMar 18, 2026
Instrumentation Laboratory GEM Premier 5000; Part No. 00055415005 recall — FDA Z-1533-2026
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control Solution Not Detected (PCSND) errors…
Class IIFDA: OngoingInstrumentation Laboratory
Browse by month
Recent recall archives
Browse recent months with enough recall history for useful comparison.
August 2026145 records · 4 categoriesJuly 2026369 records · 4 categoriesJune 2026373 records · 4 categoriesMay 2026330 records · 4 categoriesApril 2026407 records · 4 categoriesMarch 2026179 records · 4 categoriesFebruary 2026329 records · 4 categoriesJanuary 2026210 records · 4 categoriesDecember 2025184 records · 4 categoriesNovember 202596 records · 3 categoriesOctober 2025139 records · 3 categoriesSeptember 2025116 records · 3 categories