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.

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DateProductReasonClassFirm
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.