Browse Device Recalls

2,831 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,831 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 2,831 FDA device recalls in 2025.

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DateProductReasonClassFirm
Mar 4, 2025 Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre... Class I ZOLL Circulation, Inc.
Mar 4, 2025 Stimulation RC Clinician Programmer Application, Model A71400, when used with... There is a software issue that can permanently disable communication with an implantable neurosti... Class II Medtronic Neuromodulation
Mar 4, 2025 Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Mod... the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... The impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025 Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm ... product mix-up; Vascular stent labeled as one size but contains a different size. Class II Cordis US Corp
Mar 4, 2025 Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number:... the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 4, 2025 InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... Insulin pens may have been incorrectly assembled therefore users could experience the following: ... Class II Medtronic MiniMed, Inc.
Mar 4, 2025 Brand Name: ID NOW Influenza A/B 2 24T Product Name: ID NOW Influenza A/B 2 2... the impacted lots have a higher occurrence of invalid rates when compared to the product Instruct... Class II Abbott Diagnostics Scarborough, Inc.
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Mo... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) PAIN PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) BASIC CATARACT, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 stryker Latitude EV HUMERAL REVISION STEM TRIAL, L: 150mm, Size: LARGE, Side... A specific lot of Latitude Humeral Trial Stems has the incorrect direct part marking. " Laser Ma... Class II Tornier, Inc
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) HERNIA REPAIR TOTE,... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) UNIVERSAL DRAPE PAC... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe... Class II Baxter Healthcare Corporation
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CSTM PACEMAKER DRAP... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T A PACK, Model N... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LINE INSERTION PACK... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Ca... During some clinical cases, it has been observed that the SO2 value may periodically appear as d... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ARTHROSCOPIE DU GEN... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CUSTOM BLOCK KEMP P... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Ste... Five complaints received where surgeon was unable to remove and/or connect the inserter with the ... Class II ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) SKIN LESION SET, Mo... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) STANDARD D&C, Model... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) DENTAL PACK-LF, Mod... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) RHINOPLASTY PACK, M... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Mode... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Refer to RES There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) ED CRASH C-SECTION ... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Mar 3, 2025 Medline Convenience kits used for various procedures: 1) NAIL PACK, Model Nu... There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... Class II MEDLINE INDUSTRIES, LP - Northfield
Feb 28, 2025 Monterey AL Implant Inserter; 22mm; Catalog 48019140. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 18/20mm; Catalog 48019130. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Monterey AL Implant Inserter; 10/12mm; Catalog 48019100. Potential for the gold unlock button to separate from the inserter. Class II Stryker Spine
Feb 28, 2025 Phoroptor VRx Digital Refraction System Model Numbers: 16242 The head of the phoropter head could come loose and potentially detach due to a default in the as... Class II Reichert, 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.