Browse Device Recalls
2,609 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,609 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 2,609 FDA device recalls in 2023.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 15, 2023 | Philips Allura Xper, Allura Centron, Allura CV, Azurion, UNIQ Clarity, and Mu... | A damaged foot switch may cause instances where no or only intermittent x-ray radiation initiatio... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Aug 14, 2023 | KWIK-STIK, ANA (3 Strains) QC Set, REF 5065P; Microbiological testing | One lot of KWIK STIK ANA (3 strains) QC Set is missing one of the strains, 6018P Parabacteroides ... | Class III | Microbiologics Inc |
| Aug 14, 2023 | remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B St... | On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during custome... | Class II | Remel, Inc |
| Aug 10, 2023 | Brand Name: Guardian 2 System Product Name: Guardian System 2 Controller Mo... | A software update corrected an issue where "low" and "terminal" battery alerts did not display on... | Class II | Turncare, Inc |
| Aug 10, 2023 | Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pr... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Bard Marquee Disposable Core Biopsy Instrument Kit, REF: MQK2016 | Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy i... | Class II | Bard Peripheral Vascular Inc |
| Aug 10, 2023 | Veran Endobronchial: Models: INS-5925 SPiN Access Catheter¿ 180 Degree for ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | PDS II (polydioxanone) Suture, Product Numbers Z844G-50, D10065-05, D10085-05... | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... | Class II | ETHICON, LLC |
| Aug 10, 2023 | Veran : Endobronchial Models: INS-5500 View Optical Probe INS-5450 SP... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... | Class II | Covidien |
| Aug 10, 2023 | Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Functional MR V1.0 | When exporting regions of interest in DICOM SEGMENTATION format, when simultaneously exporting mu... | Class II | OLEA MEDICAL |
| Aug 10, 2023 | PDS Plus Antibacterial (polydioxanone) Suture, Product Numbers PDP072H40, PDP... | Internal testing on returned product from this lot confirmed that some PDS" II (polydioxanone) Su... | Class II | ETHICON, LLC |
| Aug 10, 2023 | Veran : Percutaneous Models: INS-5620 SPiN Perc Biopsy Needle Guide Kit - 2... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS ... | This recall has been initiated due to reports that the product code and product name were incorre... | Class II | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Welch Allyn Connex Spot Monitor | Product is being recalled due to the improper placement of a copper tape on the back of the liqui... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, R... | Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in ... | Class II | Covidien |
| Aug 10, 2023 | Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Naviga... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Baxter Epiphany Cardio Server E3 ECG Management System Servers with software ... | Epiphany, now a Baxter Healthcare company, is issuing an Urgent Medical Device Correction for the... | Class II | Baxter Healthcare Corporation |
| Aug 10, 2023 | Veran : Percutaneous Always on Track Models: INS-5040 Always-On vTrack Univ... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 10, 2023 | Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC p... | This recall has been initiated due to reports that the product code and product name were incorre... | Class I | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; cathe... | This recall has been initiated due to reports that the product code and product name were incorre... | Class II | ARROW INTERNATIONAL Inc. |
| Aug 10, 2023 | Veran : Endobronchial Always on Track Models: INS-0392 AOTT 21ga Needle, 12... | Non-conformances in Veran devices (ig4 Image Guided System, SPiN Thoracic Navigation System, SPiN... | Class II | Olympus Corporation of the Americas |
| Aug 9, 2023 | Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry Sy... | Ortho Clinical Diagnostics (QuidelOrtho) confirmed certain Proboscis/Piston Assemblies manufactur... | Class II | Ortho-Clinical Diagnostics, Inc. |
| Aug 9, 2023 | FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOF... | One respirator sample failed a filtration efficiency test. This respirator may not provide adequa... | Class II | O&M HALYARD, INC. |
| Aug 8, 2023 | Mallinckrodt One-Way Valve, 22F x 22M, a) Part #91346 (1 piece) and b) Part #... | The One-Way Valve, 22F x 22M may stick and prevent or reduce the flow of ventilated air or oxygen. | Class I | Mallinckrodt Manufacturing LLC |
| Aug 8, 2023 | Oculus Pentacam AXL Wave, Ref 70020, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 b... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | Prucka 3 Amplifiers, Model P1801PA, and Field Replaceable Units (FRUs), Model... | A diode on the power supply of the Prucka 3 Amplifier used with CardioLab/ComboLab systems could ... | Class II | GE Medical Systems Information Technologies Inc |
| Aug 8, 2023 | Oculus Myopia Master , Ref 68100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 8, 2023 | 10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 ... | There is a potential for a positive bias on Quality Control (QC) and patient sample results when ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Aug 8, 2023 | Centered Glenosphere w/Screw, CoCr/TA6V/TiN 10-degrees Tilt 32 mm, REF: 115-3210 | Centered glenosphere box may contain an eccentric glenosphere. | Class II | FX SHOULDER |
| Aug 8, 2023 | 3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, ... | There is a potential for blood backfill leakage and foreign material. | Class I | Fresenius Medical Care Holdings, Inc. |
| Aug 8, 2023 | Oculus Pentacam AXL , Ref 70100, CE 0123 | Their is a potential that optical devices with insufficient anti-reflective coating may lead to... | Class II | Oculus Optikgeraete GMBH |
| Aug 7, 2023 | Heartmate 3 LVAS Implant Kit, REF: 106524US, 106524INT; Heartmate XVE & Heart... | Inability to start and/or complete the coring procedure due to inadequate sharpness of the Apical... | Class II | Thoratec Corp. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | B. Braun NORM-JECT Luer Solo, 10 ml, Sterile-Intended to be used to deliver (... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing): 180-Gram Cement Cartridge with Breakawa... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | B.Braun NORM-JECT Luer Lock Solo, 10 ml, Sterile-Intended to be used to deli... | The sterile blister packaging may be damaged, and sterility may be compromised | Class II | B. Braun Medical, Inc. |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, All... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 7, 2023 | Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Noz... | Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, ... | Class II | Stryker Corporation |
| Aug 5, 2023 | VITROS XT Chemistry Products TBIL-ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 5, 2023 | VITROS XT Chemistry Products ALKP Slides | Samples containing high levels of ALKP (or an interfering substance) could deplete the available ... | Class II | Ortho-Clinical Diagnostics, INc. |
| Aug 4, 2023 | DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm, RE... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
| Aug 4, 2023 | DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm,... | Orthopedic device components were not subjected to final sterilization before shipment, which if ... | Class II | Encore Medical, LP |
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.