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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.