Class IIOngoingZ-0504-2026
Becton Dickinson & Company recalls BD Luer Tip Caps
BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Becton Dickinson & Com…NJNov 26, 2025
Recalls in New Jersey
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 49–60 of 125 recalls
Class IIOngoingZ-0420-2026
Integra LifeSciences Corp. (NeuroSciences) recalls TruDi¿ Navigation System - Multi Instrument Adapter
It was determined that when the navigation system is configured with specific revision combinations of the Multi Instrument Adapter together with the Patient Tracker the system may not meet its specified accuracy for vis…
Integra LifeSciences C…NJNov 12, 2025
Class IOngoingZ-0374-2026
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator 9mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Integra LifeSciences C…NJNov 12, 2025
Class IOngoingZ-0373-2026
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator 11mm. Cranial Perforator.
Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 mm and 9 mm Codman Disposable Perforators out of an abundance of caution.
Integra LifeSciences C…NJNov 12, 2025
Class IIOngoingZ-0289-2026
LeMaitre Vascular, Inc. recalls Artegraft¿ Collagen Vascular Graft
The device was incorrectly packed in the wrong size labeled outer packaging.
LeMaitre Vascular, Inc…NJOct 29, 2025
Class IIOngoingZ-0205-2026
Diagnostica Stago, Inc. recalls Product: STA Liatest D-Di
A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
Diagnostica Stago, Inc…NJOct 22, 2025
Class IIOngoingZ-0072-2026
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M
Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet and patient implant card.
LeMaitre Vascular, Inc…NJOct 15, 2025
Class IIOngoingZ-2640-2025
Howmedica Osteonics Corp. recalls 1. EXETER V40 STEM 44MM NO 2
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
Howmedica Osteonics Co…NJOct 8, 2025
Class IIOngoingZ-0034-2026
LeMaitre Vascular, Inc. recalls Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616
The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been reviewed and approved by the appropriate regulatory authority.
LeMaitre Vascular, Inc…NJOct 8, 2025
Class IIOngoingZ-2636-2025
Maquet Cardiovascular, LLC recalls Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. The VASOV…
Reports of out-of-box failures discovered during the limited launch phase. Failure modes included angled deformity at the attachment site of the Harvesting Tool Jaws and the distal end of the Harvesting Tool Shaft, jaws…
Maquet Cardiovascular,…NJOct 1, 2025
Class IIOngoingZ-2622-2025
Mindray DS USA, Inc. Dba Mindray North America recalls BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017
Potential for activation of an abnormal alarm pause.
Mindray DS USA, Inc. d…NJOct 1, 2025
Class IIOngoingZ-2588-2025
Maquet Cardiovascular, LLC recalls Heartstring III Proximal Seal System
Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the Heartstring Seal to deploy into the aortotomy, and failure of the deployed Heartstring Seal to provide adequate hemostasis…
Maquet Cardiovascular,…NJSep 24, 2025