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 |
|---|---|---|---|---|
| Jul 24, 2024 | Stryker iBur 4.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Precision Match Head, Distal Bend- intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | McKesson Syringe 60CC, Luer Lock Tip, Sterile, ITEM NO 102-S60C. Model No. ... | Affected syringes lack FDA clearance. | Class II | Cypress Medical Products LLC |
| Jul 24, 2024 | Stryker iBur 3.0mm Diamond Round, Distal Bend - intended to cut bone in the ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 5.0mm Coarse Diamond Round, Distal Bend intended to cut bone... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | (a) CardinalHealth Salem Sump Dual Lumen Stomach Tube with Anti-Reflux Valve,... | The firm received reports of breakage in the Anti-Reflux Valve (ARV) due to improper use. As a r... | Class II | Cardinal Health 200, LLC |
| Jul 24, 2024 | Stryker iBur 2.0mm Diamond Round, Distal Bend- intended to cut bone in the f... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | Stryker iBur 3.0mm Coarse Diamond Round, Distal Bend - intended to cut bone ... | Potential for the product to exhibit temperatures higher than specification where the bur shank m... | Class II | Stryker Corporation |
| Jul 24, 2024 | FreeStyle Libre 3 Sensors, REF: 72081-01, component of the FreeStyle Libre 3 ... | Users of the FreeStyle Libre 3 sensors reported situations where they were receiving erroneously ... | Class I | Abbott Diabetes Care, Inc. |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27830KA, Nephroscope for MIP M, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbe... | Footprint Client (ZFP) versions v6.0 SP9.x and SP10.x where the latest addended report is not sho... | Class II | GE Healthcare |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27840KA, Nephroscope for MIP L, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27293AA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27292AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27294AA, Hopkins Telescope 6, 18 Fr, Rx only, C... | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27093AA Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | Karl Storz - Endoskope , REF: 27092AMA, Hopkins Telescope 6, Rx only, CE 0123 | Various medical device product IFUs contain reprocessing modalities that have not been reviewed ... | Class II | Karl Storz Endoscopy |
| Jul 23, 2024 | VariSoft Infusion Set, Single Use. | Specific VariSoftTM Infusion Sets were packaged using incorrect secondary packaging (boxes) brand... | Class II | Unomedical A/S |
| Jul 22, 2024 | Sevoflurane E_Vap.(Quik-Fil):used with the A9 Anesthesia System-Used to provi... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | SlideView VS200 slide viewer, | A broken fuse inside the laser that was caused by a short circuit at PIN 4 of the DOOR CTRL. This... | Class II | EVIDENT SCIENTIFIC INC |
| Jul 22, 2024 | Isoflurane E_Vap.(Safety Filling adapter): used with the A9 Anesthesia System... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to prov... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 22, 2024 | Sevoflurane E_Vap.(Safety Filling adapter) used with the A9 Anesthesia System... | V90 electronic vaporizer anesthetic agent output may be higher than the set amount due to a compo... | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Jul 19, 2024 | BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System... | Software anomaly causing the skin temperature measurement accuracy to be slightly out of specific... | Class II | Biointellisense Inc. |
| Jul 19, 2024 | ClotTriever XL Catheter, 30 mm, REF: 41-102, used with Instructions for Use ... | Thrombectomy system catheter instructions for use updated to reduce adverse events due to the fol... | Class I | Inari Medical - Oak Canyon |
| Jul 18, 2024 | smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; ... | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | BD BACTEC MGIT 960 PZA Kit)- IVD qualitative procedure for susceptibility te... | May intermittently produce falsely resistant results for pyrazinamide (PZA) during susceptibility... | Class II | Becton Dickinson & Co. |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5 | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... | Class II | Centinel Spine, Inc. |
| Jul 18, 2024 | smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) RE... | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | smiths medical portex, Y' PIECE 15MM, REF 100/276/000 | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | smiths medical portex, Nasopharyngeal Airway, Sizes as follows: a) AIRWAY ... | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Mate... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | prodisc C SK, Total cervical disc replacement, medical device, Model/Catalog... | During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The dis... | Class II | Centinel Spine, Inc. |
| Jul 18, 2024 | smiths medical portex, 'ORATOR' SPEAKING VALVE FOR TRACHEOSTOMY TUBE, REF 100... | Uncertainty in the seal integrity of the sterile packaging. | Class II | Smiths Medical ASD Inc. |
| Jul 18, 2024 | Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M00... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 18, 2024 | VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M0012453... | There is the potential for holes in the clear sterile barrier of the device pouch which may impac... | Class II | Boston Scientific Corporation |
| Jul 17, 2024 | Mazor X. Model Number REF TPL0059; stereotaxic orthopedic instrument | Software anomalies which can result in two separate issues: A lagging screen display during a nav... | Class II | Mazor Robotics Ltd |
| Jul 17, 2024 | PE Centrifuge, REF: B36365, a component of the Power Express | The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... | Class II | Beckman Coulter Biomedical GmbH |
| Jul 17, 2024 | Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used wi... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 17, 2024 | Spectrum Wireless Battery Modules A/B/G/N, product code 36010, used with eith... | The Spectrum WBM may fail to auto-document infusion status information back to the hospital's Ele... | Class II | Baxter Healthcare Corporation |
| Jul 17, 2024 | Power Express, REF B90918 | The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... | Class II | Beckman Coulter Biomedical GmbH |
| Jul 17, 2024 | PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power E... | The adhesive joint between the plastic socket and metal component of the Power Express Sample Hol... | Class II | Beckman Coulter Biomedical GmbH |
| Jul 17, 2024 | WAVEWRITER ALPHA: Model: SC-1216, 16 IPG KIT, REF: M365SC12160; Model: SC-123... | Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system che... | Class II | Boston Scientific Neuromodulation Corporation |
| Jul 16, 2024 | Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Ev... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo Universal Ventilator, Model No. DS2000X11B | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Aust... | Firm has released a mandatory software update Version 1.05.10.00 and a User Manual addendum for a... | Class I | Philips Respironics, Inc. |
| Jul 16, 2024 | Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF... | Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec C... | Class III | Beckman Coulter, 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.