enforcement database
FDA Medical Device Recalls
3,198 documented actions on record. FDA recalls of medical devices, from Class I (reasonable probability of serious injury or death) through Class III.
- Total actions
- 3,198
- Earliest on record
- January 11, 2023
- Most recent
- August 19, 2026
- Source
- openFDA (recall)
Severity breakdown
- Critical602
- High2,499
- Medium97
Most recent medical device recalls (30 of 3,198 shown)
- Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 6" x 5", 150 count, Product N…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) SEPTO RHINO PACK , Catalog Numbe…
August 19, 2026·High
- Erbe USA Inc — Class II recall: ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
August 19, 2026·High
- MICROVENTION INC. — Class II recall: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL B…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Numb…
August 19, 2026·High
- Terumo Medical Corporation — Class II recall: GLIDESHEATH SLENDER A-KIT 6F 10CM .021GW. 5 units per box. Product Code: 60-1060…
August 19, 2026·High
- Straumann USA LLC — Class II recall: Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid,…
August 19, 2026·High
- Ventana Medical Systems, Inc. — Class II recall: navify Digital Pathology (on-prem) v2.5, Material Number 10092343001 navify D…
August 19, 2026·High
- Covidien, LP — Class II recall: Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX
August 19, 2026·High
- W L Gore & Associates, Inc. — Class II recall: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, se…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Numbe…
August 19, 2026·High
- PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Class II recall: Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234,…
August 19, 2026·High
- Covidien, LP — Class II recall: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) KIT, MER NEURO BACK , Catalog Numb…
August 19, 2026·High
- Galt Medical Corporation — Class II recall: Boston Scientific Enhance Transcarotid/Peripheral Access Kit REF: SR-4F21G7D-MP…
August 19, 2026·High
- Spectra Medical Devices, Llc — Class I recall: Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Inje…
August 19, 2026·Critical
- Baxter Healthcare Corporation — Class I recall: Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; So…
August 19, 2026·Critical
- Remel Europe Ltd. — Class II recall: Thermo Fisher Diagnostics Neisseria meningitidis Gp C 2ml/VL, Product Number R30…
August 19, 2026·High
- Covidien, LP — Class II recall: V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM0336…
August 19, 2026·High
- Spacelabs Healthcare, Inc. — Class II recall: Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number:…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) NEWNAN SMR PACK, Catalog Number: SEN21SPPMB
August 19, 2026·High
- W L Gore & Associates, Inc. — Class II recall: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1006. Flexible, se…
August 19, 2026·High
- BD SWITZERLAND SARL — Class II recall: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235…
August 19, 2026·High
- Straumann USA LLC — Class II recall: GM Helix Implant, Endosseous Dental Implant Article No. 109.984
August 19, 2026·High
- Medline Industries, LP — Class II recall: Medline Micro-Kill Bleach Germicidal Bleach Wipes,7" x 8", 150 count, 150 count,…
August 19, 2026·High
- Bioporto Diagnostics A/S — Class II recall: ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test Syste…
August 19, 2026·High
- Covidien, LP — Class II recall: Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
August 19, 2026·High
- Waldemar Link GmbH & Co. KG (Mfg Site) — Class II recall: Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rota…
August 19, 2026·High
- Cardinal Health 200, LLC — Class II recall: Cardinal Health Presource Kits: 1) BASIC PACK , Catalog Numb…
August 19, 2026·High
- Covidien, LP — Class II recall: Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31…
August 19, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.