Browse Device Recalls

3,276 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,276 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 3,276 FDA device recalls in 2024.

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DateProductReasonClassFirm
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TR... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O;... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, R... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-us... A limited number of IV bags have been found to leak during filling. Class II The Metrix Company
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; ... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; ... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672 Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2)... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DY... Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 9, 2024 Autosampler, Models: SIL-40C XR CL, SIL-40C X3 CL There have been cases of failure of the main board due to condensation water occurring in the gap... Class II Shimadzu Corp. Analytical & Measuring Instrumen...
Oct 8, 2024 MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indic... Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/... Class II ETHICON, INC.
Oct 8, 2024 Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference P... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 8, 2024 Approach Hydro ST Micro Wire Guide; Catalog prefix HMW Reference Part Numb... Affected device lots have labels that state the incorrect expiration dates. Class II Cook Incorporated
Oct 7, 2024 Philips Zenition 70, Model Number: 718133 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Oct 7, 2024 Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Philips Zenition 50, Model Number: 718096 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Oct 7, 2024 LifeVent EVO2. Model Number: SP2100X26B. Intended for invasive and non-invas... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Garbin Evo. Model Number: LD2110X23B. Intended for invasive and non-invasiv... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Aeris EVO. Model Number: VT2110X24B. Intended for invasive and non-invasive... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B,... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 7, 2024 DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361 The user of the assay may either face a failure message during re-calibration of the Hybrid.XL in... Class II DRG International, Inc.
Oct 7, 2024 Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for inva... Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit a... Class I Philips Respironics, Inc.
Oct 5, 2024 CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Patient Ele... As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... Class II St. Jude Medical
Oct 5, 2024 CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM CardioMEMSTM HF System Hosptial El... As a result of a cloud data migration of Patient and Hospital Electronic Systems (PES and HES) re... Class II St. Jude Medical
Oct 4, 2024 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4706 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 microTargeting Insertion Tube Set, P/N 66-IT-05P, Lot 244517. The intended us... A complaint was received (MDR 3002250546-2024-00003) prompting an investigation. The investigatio... Class I FHC, Inc.
Oct 4, 2024 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4720 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-101. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-1. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4702 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 CAIRE FreeStyle Comfort portable oxygen concentrator, model #AS200-103. Potential failure of affected units to recharge the battery of the oxygen concentrators. Class II Caire, Inc.
Oct 4, 2024 ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 4, 2024 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4704 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4716 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 Posi-Stop Injection Needle, 25 Gauge, Catalog Number: 4718 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push But... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation
Oct 4, 2024 CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... Class II MEDLINE INDUSTRIES, LP - Northfield
Oct 4, 2024 Posi-Stop Injection Needle, 23 Gauge, Catalog Number: 4721 Injection solutions would not flow as intended through the tip of 25ga-sized needles. Investigati... Class II Hobbs Medical, Inc.
Oct 4, 2024 Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk No... There is a potential for the product to activate without manual input when plugged into a power s... Class II Stryker Corporation

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.