Browse Device Recalls
35,307 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,307 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 35,307 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 21, 2022 | WEB Detachment Controller, REF: WDC-2, WDC, MV-WDC2. Component of WEB Aneury... | Detachment controller, of an aneurysm embolization system, has an out of specification tunnel ope... | Class II | MICROVENTION INC. |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 630G/ MMT-1715, MMT-1755, MMT-1754; MiniMed 67... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000 | Siemens has become aware of three potential software issues with ARTIS pheno systems with softwar... | Class II | Siemens Medical Solutions USA, Inc |
| Sep 20, 2022 | STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in ... | Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may re... | Class II | Ethicon, Inc. |
| Sep 20, 2022 | Allen Advance Table, RSP-ADVANCE TABLE: a) REF A-71100-US, #107003, b) A-711... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | C-Flex Polar Head Positnr-Device Only, SSP-NEUROSURGICAL HEADREST, REF A-7070... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104.... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devic... | Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instr... | Class II | Intuitive Surgical, Inc. |
| Sep 20, 2022 | Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Ki... | Product may not be sterile | Class II | TELEFLEX LLC |
| Sep 20, 2022 | Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMPT, REF F-40018, #... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, R... | the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly,... | Class II | Baxter Healthcare Corporation |
| Sep 20, 2022 | Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711, MMT-1712... | Medtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems... | Class II | Medtronic MiniMed |
| Sep 20, 2022 | Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone ... | Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the ... | Class II | Angiodynamics, Inc. |
| Sep 19, 2022 | Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnost... | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 19, 2022 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administratio... | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patie... | Class II | DeVilbiss Healthcare LLC |
| Sep 19, 2022 | Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro di... | Potential for falsely elevated LITH_2 and Li results on the Atellica CH 930 Analyzer. In the wors... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Sep 16, 2022 | Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lo... | Blister package had an unsealed edge compromising sterility. | Class II | International Medical Industries, Inc. |
| Sep 16, 2022 | LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop)... | Class II | Fresenius Kabi USA, LLC |
| Sep 16, 2022 | Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical a... | Update to the Instruction for Use (IFU): Olympus is adding a new warning against the use of acces... | Class II | Olympus Corporation of the Americas |
| Sep 15, 2022 | B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (car... | The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10... | Class II | Medical Action Industries, Inc. 306 |
| Sep 15, 2022 | CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per c... | The extension set has a high probability of potential failure which could lead to possible leakag... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 uni... | The extension set has a high probability of failure which could lead to possible leakage or deta... | Class II | B. Braun Medical, Inc. |
| Sep 15, 2022 | BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog... | The affected product contains isobutylene which has recently demonstrated potential interference ... | Class II | Becton Dickinson & Company |
| Sep 15, 2022 | Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per ca... | The extension set has a high probability of failure which could lead to possible leakage or detac... | Class II | B. Braun Medical, Inc. |
| Sep 14, 2022 | Prismaflex M Set: M150 (product code 109990). For use in providing continuo... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Disc Preparation instruments contained in the following products: CI-11050-0... | Due to manufacturing instruments which included additional features and adequate consideration wa... | Class II | Alphatec Spine, Inc. |
| Sep 14, 2022 | Prismaflex HF Set: HF1000 (product code 107140), HF1400 (product code 107142... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Lue... | Sterile extension sets were distributed without an expiration date | Class II | Avanos Medical, Inc. |
| Sep 14, 2022 | ARIES SARS-CoV-2 Assay, REF: 50-10047 | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction ... | Class II | Luminex Corporation |
| Sep 14, 2022 | Prismaflex ST Set: ST60 (product code 107643), ST100 (product code 107636), ... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex M Set: M60 (product code 106696), M100 (product code 106697). Fo... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | Prismaflex HF20 Set (product code 109841). For use in providing continuous f... | Within the current Prismaflex set IFU (instructions for use), there is a mistranslation of the Ex... | Class II | Baxter Healthcare Corporation |
| Sep 14, 2022 | ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 ... | Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affe... | Class II | ARROW INTERNATIONAL Inc. |
| Sep 13, 2022 | NovoTHOR Gen 2.0 whole body red light therapy bed, model S1176 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... | Class II | Thor Photomedicine Ltd |
| Sep 13, 2022 | G041 POD, THOR NOVO GEN 2.0 XL whole body red light therapy bed, model S1177 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... | Class II | Thor Photomedicine Ltd |
| Sep 13, 2022 | NovoTHOR Gen 2.5 XL whole body red light therapy bed, model S2184. | Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... | Class II | Thor Photomedicine Ltd |
| Sep 13, 2022 | NovoTHOR Gen 2.5 Regular whole body red light therapy bed, model S2183 | Failure of ball stud components causing the gas strut on one side to detach from the canopy, maki... | Class II | Thor Photomedicine Ltd |
| Sep 12, 2022 | Orthex Large Bone Shoulder Bolt, model no. AS-17 | Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with fram... | Class II | OrthoPediatrics Corp |
| Sep 9, 2022 | MEDLINE PHERIPHERAL BLOOD CULTURE DRAW, Reorder #: DYNDH1561 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE PRE-OP CHG BATHING KIT Reorder #: P164756 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 9, 2022 | MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245 | Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration d... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 8, 2022 | Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip N... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91 | The kits are being recalled due to a lack of sterility of a spare needle contained within the kit... | Class II | SunMed Holdings, LLC |
| Sep 8, 2022 | Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G... | An increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked... | Class II | Abbott Vascular |
| Sep 8, 2022 | cobas 5800 instrument, Material No. 08707464001. Used for automated Polymeras... | Reported false positive and invalid results on the affected devices due to anomalous baselines. T... | Class II | Roche Molecular Systems, Inc. |
| Sep 7, 2022 | THERMOCOOL SMARTTOUCH SF Bi-Directional Navigation Catheter, REF: D-1348-05-S... | Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irr... | Class II | Johnson & Johnson Surgical Vision, 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.