Browse Device Recalls

2,032 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,032 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 2,032 FDA device recalls in NJ.

Date	Product	Reason	Class	Firm
Feb 4, 2026	Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protei...	The potential of out-of-range results and an underestimation of the free protein S level in norma...	Class II	Diagnostica Stago, Inc.
Jan 27, 2026	10mL Non-Sterile BD Luer-Lok Tip Syringe Only. Catalog Number: 301029. 850 bu...	During the bulk packaging process, some Luer Slip syringes were incorrectly included in a batch d...	Class II	Becton Dickinson & Company
Jan 23, 2026	CS100 IABP. Software Version CS100 IABP Q.01.	The firm has identified that the battery runtime and cycle specifications contained in the device...	Class II	Datascope Corp.
Jan 23, 2026	CS300 IABP. Software Version CS300 IABP C.01.	The firm has identified that the battery runtime and cycle specifications contained in the device...	Class II	Datascope Corp.
Jan 16, 2026	MEDIHONEY CALCIUM ALGINATE WITH ACTIVE LEPTOSPERMUM HONEY. Model Numbers: (1)...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026	Private Label CVS. Model Number: CVS405406. Helps maintain a moist woun...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jan 16, 2026	MediHoney Gel with Active Leptospermum Honey. Model/Catalog Numbers: (1) 3180...	Potential packaging failures, which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Dec 15, 2025	Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ...	Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted...	Class II	Diagnostica Stago, Inc.
Dec 12, 2025	Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ...	Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi...	Class II	Integra LifeSciences Corp. (NeuroSciences)
Dec 12, 2025	Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN...	Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi...	Class II	Integra LifeSciences Corp. (NeuroSciences)
Nov 18, 2025	Hardware configuration of the BeneVision Central Monitoring System (CMS), mar...	When the Worstation of the BeneVision DMS has a specific hardware configuration, the computer may...	Class II	Mindray DS USA, Inc. dba Mindray North America
Nov 12, 2025	The Stryker CranialMask Tracker is a single-use device consisting of a flexib...	When the device is activated during surgery, the device software issues an error message "Instrum...	Class II	Howmedica Osteonics Corp.
Nov 4, 2025	Cardiosave Hybrid. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Nov 4, 2025	Cardiosave Rescue. Intra-Aortic Balloon Pump system.	The IFU addendum revises the Preventative Maintenance schedule to align with the update introduce...	Class II	Datascope Corp.
Oct 23, 2025	Cardiosave Hybrid	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.	Class III	Datascope Corp.
Oct 23, 2025	Cardiosave Rescue	The IFU addendum updates the Vibration and Shock Table to reference the correct standards.	Class III	Datascope Corp.
Oct 20, 2025	Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe...	Potential for anesthesia leakage.	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 20, 2025	Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La...	Potential for anesthesia leakage.	Class II	Mindray DS USA, Inc. dba Mindray North America
Oct 14, 2025	BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;	BD has confirmed through internal testing that certain device trays failed routine biocompatibili...	Class II	Becton Dickinson & Company
Oct 3, 2025	TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Produc...	It was determined that when the navigation system is configured with specific revision combinatio...	Class II	Integra LifeSciences Corp. (NeuroSciences)
Sep 26, 2025	CODMAN Disposable Perforator 9mm. Cranial Perforator.	Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m...	Class I	Integra LifeSciences Corp. (NeuroSciences)
Sep 26, 2025	CODMAN Disposable Perforator 11mm. Cranial Perforator.	Expansion of recall of size 14 mm Codman Disposable Perforators for inadequate welds to size 11 m...	Class I	Integra LifeSciences Corp. (NeuroSciences)
Sep 25, 2025	Artegraft¿ Collagen Vascular Graft; REF: AG1015;	The device was incorrectly packed in the wrong size labeled outer packaging.	Class II	LeMaitre Vascular, Inc.
Sep 17, 2025	InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE PO...	InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in f...	Class II	Enterix, Inc.
Sep 12, 2025	Product: STA Liatest D-Di; REF: 00515;	A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.	Class II	Diagnostica Stago, Inc.
Sep 2, 2025	Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616, (2) AG 630, (3...	The bovine carotid arteries used to produce the impacted grafts from affected lots were sourced u...	Class II	LeMaitre Vascular, Inc.
Aug 28, 2025	1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V4...	a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may c...	Class II	Howmedica Osteonics Corp.
Aug 25, 2025	Artegraft Collagen Vascular Graft. Model/Catalog/Part Numbers: AG630M, AG636...	Devices were distributed with incorrect label without CE and UKCA mark, missing patient leaflet a...	Class II	LeMaitre Vascular, Inc.
Aug 21, 2025	i-STAT EG7+ cartridge. List Number: 03P76-25.	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd...	Class II	Abbott Point Of Care Inc.
Aug 21, 2025	i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K...	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd...	Class II	Abbott Point Of Care Inc.
Aug 21, 2025	i-STAT CG4+ cartridge (white). List Number: 03P85-25.	Lack of a 510(k) premarket clearance for the i-STAT CG4+ cartridge to reflect updated sample type...	Class II	Abbott Point Of Care Inc.
Aug 21, 2025	i-STAT EG6+ cartridge. List Number: 03P77-25.	Lack of a 510(k) premarket clearance for the i-STAT CG8+, EG7+ and EG6+ cartridges to reflect upd...	Class II	Abbott Point Of Care Inc.
Aug 15, 2025	Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occlu...	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 15, 2025	BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA0001...	Potential for activation of an abnormal alarm pause.	Class II	Mindray DS USA, Inc. dba Mindray North America
Aug 15, 2025	Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occlu...	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 15, 2025	Heartstring III Proximal Seal System. Intravascular anastomosis occluder.	Three failure modes have been identified: failure of the Heartstring Seal to load, failure of the...	Class II	Maquet Cardiovascular, LLC
Aug 6, 2025	Vasoview Hemopro 3 Endoscopic Vessel Harvesting System Model No. C-VH-6000. ...	Reports of out-of-box failures discovered during the limited launch phase. Failure modes included...	Class II	Maquet Cardiovascular, LLC
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Adhesive Sheet Mod...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Surgical Adhesive Sheet ...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney ¿ Product Name: MediHoney ¿ Tube Model/Catalog Number...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Hydrogel Model/Catalog Numb...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ HCS Sheet Dressing with Lept...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney¿ Product Name: MediHoney¿ Adhesive Hydrogel Sheet Dres...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number:...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Aug 5, 2025	Brand Name: MediHoney ¿ Product Name: MediHoney¿ Paste Model/Catalog Number...	Packaging failures were identified which could lead to a breach in the sterile barrier.	Class II	Integra LifeSciences Corp. (NeuroSciences)
Jul 21, 2025	STA - Fibrinogen 5. Model/Catalog Number: 00674. The STA - Fibrinogen 5 k...	Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap...	Class II	Diagnostica Stago, Inc.
Jul 21, 2025	STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Ant...	Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap...	Class II	Diagnostica Stago, Inc.
Jul 21, 2025	STA Satellite. Product Code: All references. All software versions. The ST...	Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap...	Class II	Diagnostica Stago, Inc.
Jul 21, 2025	STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti...	Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH ap...	Class II	Diagnostica Stago, Inc.
Jul 16, 2025	Pentax Medical Video Processor; Model Number: EPK-i8020c;	During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c serie...	Class II	Pentax of America Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.