Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PAC... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Pol... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Implantable Venous Acces... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; P... | Potential breach in pouch packaging which could lead to loss of sterility. | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 13, 2025 | remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnosti... | Product may contain surface and subsurface contamination of Listeria monocytogenes which is typic... | Class II | Remel, Inc |
| Feb 12, 2025 | namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical con... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | Z1 Femoral Hip System, Product Number 611777612 | There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the d... | Class II | Zimmer, Inc. |
| Feb 12, 2025 | namic convenience kits labeled as: MTS,COLOR,PML,KIT,-,FRENCH HOSPITAL PG;... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | namic convenience kits labeled as: PML,72,ADULT,FLL-MLL,-,OEM, REF 8064172... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 12, 2025 | BD BBL TB Stain Kit K, Catalog (REF): 212522 | One component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate o... | Class II | Becton Dickinson & Co. |
| Feb 12, 2025 | Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may hav... | Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fir... | Class II | Remel, Inc |
| Feb 12, 2025 | namic convenience kits labeled as: 1) MTS,4 VALVE,LFT,HRT,KIT-AHS-A*,NW, R... | The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess ma... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ6273... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYN... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJH... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Nu... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number D... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4... | The incorrect computed patient age is showing in VX for patients less than 3 months old. | Class II | FUJIFILM Healthcare Americas Corporation |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ARTHROSCOPY PACK, Pack Number DYNJHS... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ09230... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CLOVIS ROBOTIC-LF, Pack Number DYNJ6... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ800... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILATERAL FACET TRAY, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356 | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ACOUSTIC NEUROMA PACK-LF, Pack Numbe... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) ANGIOGRAPHY SPECIALS | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) AV FISTULA PACK-LF, Pack Number DYNJ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 11, 2025 | Medline procedure kits labeled as: 1) C SCOPE DISPOSABLE KIT, Pack Number ... | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on Marc... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 10, 2025 | Alcon Custom Pak with Non-Latex Symbol, Pak: 12771-18, 18050-10, 18252-17, 12... | Customer-designed sterile surgical procedure packs contain latex components as specified; but, th... | Class II | Alcon Research LLC |
| Feb 10, 2025 | Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1 | Under certain circumstances, it can occur that patient records from unrelated individuals are aut... | Class II | Brainlab AG |
| Feb 10, 2025 | Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal... | Candida Immunodiffusion Antigen may have reduced sensitivity which could result in false negative... | Class II | Immuno-Mycologics, Inc |
| Feb 7, 2025 | Bodor's I series laser cutting machine. | The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(... | Class II | Jinan Bodor Cnc Machine Co Ltd |
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.