Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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: 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: 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: 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 | 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: 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 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 | 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 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 | 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 | 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 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 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 | 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 | 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 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 | 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 | 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, 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 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 15, 2024 | Product Desc: Product Name: 20 Gauge V-Lance Knife Model/Catalog Number: 806... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT HP2 DB SLIT 3.2MM ANGCE Model/Catalog N... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: TOTALPLUS,25+ 7.5CPM VALV WD6 Model/Catalog Number: 8065751618... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SLIT FULL HANDLE3.0MM ANG DUAL Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: A-OK SATINSLIT FULL HANDLE2.75MM ANG SG Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: TOTAL PLUS,25+,10K VALVE WD Model/Catalog Number: 8065752438 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25GA VALVED ENTRY SYSTEM,3CT Model/Catalog Number: 8065751658 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+TTLPL VPK 20000CPM BEV VAL Model/Catalog Number: 8065753106... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ CMB PAK 10K CPM,V,WA 0.9 Model/Catalog Number: 8065752451 ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: Alcon Custom Pak Model/Catalog Number: Many Software Version:... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: ClearCut S Safety Sideport Knife 1.0mm Dual Bevel Model/Catalo... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SATINSLIT FULL HANDLE3.0MM ANG Model/Ca... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ TOTALPLUSr CP PAK 20K CPM BWV .9 IU Model/Catalog Number: ... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | Product Name: 25+ CMB PAK 10K CPM,V,STD 0.9 Model/Catalog Number: 8065752450... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
| Jul 15, 2024 | TiBrid Stand Alone Intervertebral Body Fusion Device, TiBrid SA Angled Screwd... | Failure of fusion system instruments in the field. | Class II | Omnia Medical |
| Jul 15, 2024 | Product Desc: Product Name: CLEARCUT SB INTREPID 2.2 ANG Model/Catalog Numbe... | Alcon has detected an increase in complaint reports related to sharpness for specific ClearCut Du... | Class II | Alcon Research LLC |
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.