Browse Device Recalls
5,424 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 5,424 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 5,424 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 12, 2023 | Medtronic Mo.Ma Ultra Proximal Cerebral Protection Device, Model Number MOM01... | The Mo.Ma Ultra device manifold is labelled with 2 stickers, an inferior and superior sticker, on... | Class II | Medtronic Inc |
| Oct 11, 2023 | BD Alaris Pump infusion sets (Product Name, Catalog #) BD AlarisTM Pump In... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Oct 11, 2023 | BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension ... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Oct 11, 2023 | BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILT... | Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DE... | Class II | Becton Dickinson & Company |
| Oct 10, 2023 | Stay Safe Cap | Updating the labeling to include additional warnings and contraindications for potential side eff... | Class II | Fresenius Medical Care Holdings, Inc. |
| Oct 9, 2023 | MED-810A Zemits NDPrime Laser products | Advance-Esthetic LLC failed to comply with the applicable standards regarding Electronic Product ... | Class II | Advance-Esthetic LLC |
| Oct 5, 2023 | REF 130-03-738, All-Poly e + Patella, Domed Tri-Peg, 9x38mm, STERILE H2O2 | Mislabeling | Class II | Encore Medical, LP |
| Oct 5, 2023 | Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32... | Mislabeling | Class II | Encore Medical, LP |
| Oct 4, 2023 | VERIQUICK PREGNANCY TEST 1CT, SKU 901260 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Integris-Allura IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | Azurion IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | ORAL B MOUTH SORE RINSE 237ML, SKU 999087 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | FIXODENT ORG CREAM 2.4OZ, SKU 906018 FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU ... | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | AT HOME MARIJUANA TEST STRIP, SKU 900752 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Zenition 50 & 70 Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | GOODSENSE DENTURE CLEANSER GRN TAB 40CT, SKU 906312 GOODSENSE DENTURE CLEAN ... | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | CLEARBLUE SMART COUNTDOWN PRGNCY TST 1CT, SKU 900260 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Veradius Unity Mobile Surgery C-arm | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | ARC TEETH WHITENING PEN 0.06 FL OZ, SKU 997950 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | BV Endura, BV Pulsera Philips Image Guided Therapy-Systems (IGTS)Mobile Surge... | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | FIRST RESPONSE 2 CT, SKU 902343 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | Allura Xper IGTS Fixed Systems | Philips has become aware of an issue with the Philips Integris-Allura, Allura Xper and Azurion sy... | Class II | Philips North America |
| Oct 4, 2023 | DENTEMP ONE STEP .077OZ, SKU 902139 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 4, 2023 | MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935 | Products were stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
| Oct 2, 2023 | Edge Biologicals STERILE WATER, 3ML, 100/PK CAT T-0780 Sterile Water, 3mL... | Due to product outer packaging incorrectly labeled. | Class II | Edge Biologicals Inc |
| Oct 2, 2023 | ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite Sy... | Incorrect pouch labels, the contents within the mislabeled pouch were Roller Bar electrodes. | Class II | Olympus Corporation of the Americas |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Glucose and Lactate... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Part Numbers 00024307504, 00024330... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 29, 2023 | Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036. | A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled e... | Class II | Atrium Medical Corporation |
| Sep 29, 2023 | GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 000243... | Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (... | Class II | Instrumentation Laboratory |
| Sep 27, 2023 | JOURNEY II BCS ARTICULAR INSERT, LEFT 10 MM SIZE 5-6, REF 74027262; knee pros... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 27, 2023 | JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 7402926... | The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II ... | Class II | Smith & Nephew, Inc. |
| Sep 26, 2023 | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208,... | Non-sterile product labeled as sterile was distributed. | Class I | Cordis US Corp |
| Sep 22, 2023 | DBX Demineralized Bone Matrix Putty 10cc-Indicated for treatment of surgicall... | Units are labeled as 10cc; however the units have a fill volume of 1cc units. This may result in ... | Class II | Musculoskeletal Transplant Foundation, Inc. |
| Sep 19, 2023 | Vasoview 6 Pro (VV6) - Endoscopic Vessel Harvesting System, Model VH-2400 pri... | Device packaged inside an incorrect outer box; displaying artwork & illustrations for a different... | Class II | Maquet Cardiovascular, LLC |
| Sep 15, 2023 | BD Alaris PCU REF 8015 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | BD Alaris Syringe Module, REF 8110 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 15, 2023 | Alaris PCA Module 8120 | Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling ... | Class I | CareFusion 303, Inc. |
| Sep 12, 2023 | BD BACTEC Plus Aerobic/F Culture Vials, Catalog Number 442023 | Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicat... | Class II | Becton Dickinson & Co. |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 0.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 1.0MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 18CM IM DISP BAYONET 1.0MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM SLM DISP BAYONET 0.5MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SM DISP BAYONET 0.5MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 23CM IM DISP BAYONET 1.0MM TIP, Ca... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
| Sep 11, 2023 | Disposable Spetzler-Malis Bipolar forceps, 20CM SLM DISP BAYONET 1.0MM, Catal... | An error was identified on the expiration date of the product label. The shelf life for the produ... | Class II | Stryker Corporation |
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.