Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 23, 2024 | URINE KIT W/BD CUP, SKU DYLAB1001A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | URINE KIT, SKU DYKM1845; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set (long) with Titanium Spike, Par... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | URINE COLLECTION KIT, SKU DYKM1848A DYKM2005 DYKM2151 DYLAB1004 DYLAB1004... | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | UA KIT, SKU DYKM1690A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set (short) with Titanium Spike, Pa... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV19 | During internal testing it was found that if the system is Ready to expose and the hand switch is... | Class II | Micro-X Ltd. |
| Oct 23, 2024 | Clean Catch Kit, SKU DYKM1833A; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Lab Kit, SKU DYLAB1018; Component No. 503581 | Specimen container included in kits is labeled as sterile, but has been identified to be non-ster... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 23, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | There has been an increase in the number of complaints related to the separation of the female co... | Class II | Baxter Healthcare Corporation |
| Oct 22, 2024 | Allegedly counterfeit batteries manufactured by CSB batteries being used with... | ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infu... | Class I | ICU Medical, Inc. |
| Oct 22, 2024 | Ivalon Anatomical Nasal Packing with Airway Tube and String, 8.0 cm x 1.5cmx ... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 22, 2024 | MICRO-X Rover Mobile X-ray System, # MXU-RV35 | Mobile x-ray system receiving/storage(operation) requirements to be followed: Temp:14 to 131(50 t... | Class II | Micro-X Ltd. |
| Oct 22, 2024 | Ivalon Eye Wick 20cm- Intended to be used for the removal and collection of ... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 22, 2024 | Ivalon CELLULOSE SURGICAL SPEAR- Intended To Be Used During Ophthalmic Surgi... | Potential for package seal to be out of specification and the sterile barrier cannot be guarantee... | Class II | Carwild Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number T... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | JuggerLoc/ToggleLoc 2.9mm Drill Guide, Model number 110027357 | Firm received complaints reporting that guides were warped when pulled out of packaging. This iss... | Class II | Biomet, Inc. |
| Oct 21, 2024 | Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain a... | A manufacturing defect causes Atellica CH Reaction Ring Cuvette Segments with lot numbers N15 o... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp EX Short, Part... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Medline Iris Scissors, Single-Use, Curved, Standard 4.5 , Model Nos. DYNJ0404... | Tip protector may fall off within the packaging, resulting in compromised sterile barrier system ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Atellica¿ CH ¿2-Microglobulin (B2M) - In vitro diagnostic use in the quantita... | Potential for falsely depressed auto-diluted results for samples above the measuring interval of... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 21, 2024 | Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing... | Due to improper labeling of products. An intended use on the label has not been reviewed and appr... | Class II | Karl Storz Endoscopy |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number R... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 21, 2024 | Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp, Part Number 5... | Baxter is aware of several recalls by other manufacturers related to the potential risk of exposu... | Class I | Baxter Healthcare Corporation |
| Oct 18, 2024 | Essenz HLM (Heart-Lung Machine), REF: 49-00-10, with Software | Heart-Lung Machine GUI touchscreen may go dark for 10-15 seconds, safety/performance functions re... | Class II | LivaNova Deutschland GmbH |
| Oct 18, 2024 | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. ... | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage... | Class II | Zyno Medical LLC |
| Oct 18, 2024 | human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, R... | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle o... | Class II | HUMAN MED AG |
| Oct 17, 2024 | Abbot Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 29 mm, NV... | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor, Vision Technology, Transcatheter Aortic Heart Valve, 27 mm, N... | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor Titan, Vision Technology, Transcatheter Aortic Heart Valve, 3... | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | cobas HCYS, Homocysteine Enzymatic Assay, Material Number REF 06542921190, fo... | Abnormal calibration signals and control recovery issues on the Homocysteine Enzymatic (HCYS) Ass... | Class II | Roche Diagnostics Operations, Inc. |
| Oct 17, 2024 | Abbott Navitor Transcatheter Aortic Heart Valve, 29 mm, NVTR-29, Sterile | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 17, 2024 | Abbott Navitor Transcatheter Aortic Heart Valve, 27 mm, NVTR-27, Sterile | A manufacturing error resulting in acceptance of valves with a leaflet deflection value that was ... | Class II | Abbott Medical |
| Oct 16, 2024 | Acrobat-i Positioner. Model Number C-XP-5000Z | Deviations in the manufacturing process created a compromise in the sterile barrier, in which ste... | Class II | Maquet Cardiovascular, LLC |
| Oct 16, 2024 | MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline SKU REF NEXCONNECT, Catheter Con... | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 16, 2024 | MEDLINE procedure kits labeled as follows: 1) NEURAXIAL KIT, REF PAIN1876A | The connectors may not allow catheters to be inserted as intended if the connector is not in the ... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.