Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
-
Class II · 7 months ago
Altruan GmbH Brand Name: Bisaf Strep A Self-Test. Test for detection of group recall: Product not cleared by the FDA
Product not cleared by the FDA.
-
Class II · 7 months ago
Medartis AG Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7 recall: Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws
Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.
-
Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model SL Connection Component incl. PE-Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
-
Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
-
Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
-
Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 PAK recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
-
Class II · 7 months ago
Lutronic Corporation Clarity II Laser System recall: Reports of devices sparking/popping and potentially burning patients
Reports of devices sparking/popping and potentially burning patients.
-
Class II · 7 months ago
Medline Surgical Drapes: Mdtbtcs6070GN Dbd-Drape,Cover,Table recall: Fabric may experience premature delamination when using included laundering
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting…
-
Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
-
Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model SL Connection Component incl. PE-Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
-
Class II · 7 months ago
Medline Medcrest Surgical Gowns: Mdtgxc4J5XL Dbq-Gown,Surg,Xalt recall: Fabric may experience premature delamination when using included laundering
Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting…
-
Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
-
Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
-
Class II · 7 months ago
Ion Beam Applications S.A. IBA Proton Therapy System - Proteus 235 recall: It was identified that eh Universal Beam Triggering Interface (UBTI)
It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition…
-
Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
-
Class II · 7 months ago
Exactech, Inc. Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/ recall: Impactor handle may be missing cross-pin
Impactor handle may be missing cross-pin
-
Class II · 7 months ago
Becton Dickinson & Company 10mL Non-Sterile BD Luer-Lok Tip Syringe Only recall: During the bulk packaging process, some Luer Slip syringes were incorrectly
During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch designated for Luer Lok syringes.
-
Class II · 7 months ago
Altruan GmbH Clearest Strep-A Cassette Test. Test to determine the presence of group recall: Product not cleared by the FDA
Product not cleared by the FDA.
-
Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 560010-2L recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
-
Class II · 7 months ago
Instrumentation Laboratory GEM Premier 5000 recall: Confirmed customer complaints indicating that GEM PAKs (cartridges)
Confirmed customer complaints indicating that GEM PAKs (cartridges) for the GEM Premier 5000 may experience an increased incidence of Process Control…
-
Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 860010-1L recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
-
Class II · 7 months ago
Waldemar Link GmbH & Co. KG Endo-Model Replacement Plateau recall: The potential for an implant with a plateau screw where the bushing
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
-
Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 361910-1A recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.
-
Class III · 7 months ago
Penner Pacific Bathing Spa, Model Numbers 360010-2WT recall: The device does not bear a unique device identifier
The device does not bear a unique device identifier.