Browse Device Recalls
2,447 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,447 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 2,447 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2023 | Aesculap Caiman Articulating D5/360MM - An electrosurgical cutting and coagul... | Potential for the spring to become loose and fall out of the device, if the spring falls out duri... | Class II | Aesculap Implant Systems LLC |
| Mar 20, 2023 | ExactaMed Oral Dispenser - 20 mL Clear Pharmacy Pack, REF H9387120; Oral medi... | ExataMed 20 mL oral dispenser component of the Clear Pharmacy Pack may have particulate matter. | Class II | Baxter Healthcare Corporation |
| Feb 27, 2023 | CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular he... | Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Fem... | Class II | Zimmer, Inc. |
| Feb 14, 2023 | Amicus MNC Apheresis Kit Double Needle. Component of Amicus Separator multi... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 14, 2023 | Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedur... | Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis ... | Class II | Fenwal Inc |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM2000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3000, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Feb 7, 2023 | CardioMEMS HF System PA Sensor and Delivery System, Model Number CM3100, The ... | Select CardioMEMS PA Sensors (Model CM2000) operate outside of the intended frequency range at hi... | Class II | St. Jude Medical |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104JP | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1205 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1102 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF MCS1705PU | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1103 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1101 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare HVAD Pump Kit, REF 1104CA-CLIN | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 29, 2022 | HeartWare Model 1100 | Over time, the driveline cover may become hardened, creating difficulty or an inability to slide ... | Class II | Heartware, Inc. |
| Nov 18, 2022 | The Natus Cranial Access Kit is designed to be a complete, single use and dis... | Due to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical dra... | Class II | Natus Medical Incorporated |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT- Intended for IV access device ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START KIT-Intended for IV Access CATALOG ... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Nov 18, 2022 | Cardinal Health Presource Packs IV START TRAY I-Intended for IV access device... | Presource Kits contains the ICU MicroClave Clear Connector due to a manufacturing defect there i... | Class II | Cardinal Health 200, LLC |
| Oct 31, 2022 | Alcon Custom Pak Surgical Procedure Pack | Due to difficulty removing the liner on the adhesive components of the affected drapes and as a r... | Class II | Alcon Research, LLC |
| Oct 21, 2022 | Busse SPINE INJECTION TRAY-Intended as a nerve block REF No. 8563R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 21, 2022 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Kits containing 3M Steri-Drape Surgical Drapes recalled by 3M due to liner on the adhesive compon... | Class II | Busse Hospital Disposables, Inc. |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020NS, general surge... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061, general su... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film and Pouch, REF 1061NS, general ... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030, general surger... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Incise Film, REF 1021NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060NS, general surgery d... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NS, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Adhesive Aperture, REF 1030NS, general surg... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Wide Adhesive Aperture, REF 1033, general s... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Urological Drape, REF 1071, general surgery (urology) drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Towel Drape, REF 1000NSD, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Medium Drape with Incise Film, REF 1060, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Large Towel Drape, REF 1010, general surgery drape | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Oct 6, 2022 | 3M Steri-Drape, Small Drape with Adhesive Aperture, REF 1020, general surgery... | During a recent investigation, 3M confirmed the liner on the adhesive component of the affected d... | Class II | 3M Healthcare Business |
| Sep 30, 2022 | CENTURION MEDICAL PRODUCTS NICU PICC INSERTION BUNDLE W/O, REF CVI4470. Conv... | Medline received complaints on some of the breather pouches with in the sterile surgical kits sho... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| 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 | 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 2.0 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 | 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 |
| Aug 12, 2022 | DeRoyal Sterile Custom Kits containing ICU Medical MicroClave Clear Connectors | Procedure packs contained a recalled product. | Class II | DeRoyal Industries Inc |
| Aug 1, 2022 | 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 C... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, Inc. |
| Aug 1, 2022 | 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Re... | Due to a manufacturing defect which results in a visible gap between the connector's top and bott... | Class II | ICU Medical, 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.