enforcement database
FDA Medical Device Recalls
2,943 documented actions on record. FDA recalls of medical devices, from Class I (reasonable probability of serious injury or death) through Class III.
- Total actions
- 2,943
- Earliest on record
- January 11, 2023
- Most recent
- July 15, 2026
- Source
- openFDA (recall)
Severity breakdown
- Critical567
- High2,281
- Medium95
Most recent medical device recalls (30 of 2,943 shown)
- Think Surgical, Inc. — Class II recall: TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia T…
July 15, 2026·High
- Encore Medical, LP — Class II recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/…
July 15, 2026·High
- Olympus Corporation of the Americas — Class II recall: Olympus Single Use Distal Cover, Catalog Number MAJ-2315, Used with: EVIS EXERA…
July 15, 2026·High
- Elekta, Inc. — Class II recall: Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Appli…
July 15, 2026·High
- Elekta, Inc. — Class II recall: Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description:…
July 15, 2026·High
- Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569D;…
July 15, 2026·High
- Integra LifeSciences Corp. (NeuroSciences) — Class II recall: OmniTract Surgical Retractor System, which includes 633 of the firm s product co…
July 15, 2026·High
- WALLAC OY — Class II recall: GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic.…
July 15, 2026·High
- Klowen Braces — Class II recall: KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033,
July 15, 2026·High
- Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) ANESTHESIA KIT PEDS 90-LF, Model Number: DYNJAP101…
July 15, 2026·High
- Elekta, Inc. — Class II recall: Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary…
July 15, 2026·High
- Medtronic MiniMed, Inc. — Class II recall: MiniMed 780G Insulin Pump, REF: MMT-1885, MMT-1886, MMT-1895, MMT-1896
July 15, 2026·High
- Encore Medical, LP — Class II recall: Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/…
July 15, 2026·High
- ConvaTec, Inc — Class II recall: Aquacel Ag Surgical SP REF: 413556 9cm x 15cm/3.5 in. x 6 in., Sterile R
July 15, 2026·High
- Fresenius Medical Care Holdings, Inc. — Class II recall: 5008X Blood Tubing Set, 24 units per case. Includes the below model numbers and…
July 15, 2026·High
- CMR SURGICAL LIMITED — Class II recall: Brand Name: Versius Surgical System US Product Name: Vesius Surgeon Console US…
July 15, 2026·High
- Siemens Healthcare Diagnostics, Inc. — Class II recall: Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
July 15, 2026·High
- Biomerieux Inc — Class II recall: VITEK 2 AST-N447 TEST KIT Product reference 424620
July 15, 2026·High
- Boston Scientific Neuromodulation Corporation — Class II recall: Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DR…
July 15, 2026·High
- Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) OPEN HEART PEDS PACK, Model Number: DYNJ88569; 2…
July 15, 2026·High
- Bard Access Systems, Inc. — Class II recall: CK000495A Poly Midline Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741121609…
July 8, 2026·High
- TELEFLEX LLC — Class II recall: Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotto…
July 8, 2026·High
- Boston Scientific Corporation — Class II recall: CRE Pro Wireguided 15-18mm 240cm
July 8, 2026·High
- Mentor Texas LP — Class II recall: SYRINGE LUER LOK 10CC-200/BOX BD Product Code: 302995 Mentor Product Code: B96…
July 8, 2026·High
- Masimo Corporation — Class II recall: Radius VSM ECG pre-connected Set, REF: 4842, 4695
July 8, 2026·High
- W L Gore & Associates, Inc. — Class II recall: GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers…
July 8, 2026·High
- Remel, Inc — Class II recall: GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
July 8, 2026·High
- Bard Access Systems, Inc. — Class II recall: 5855240 Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter 12 Fr Tr…
July 8, 2026·High
- Medline Industries, LP — Class II recall: Medline Convenience Kits: 1) STD, INTRO-FLEX INTRODUCER 6F, C, Model Number: I5…
July 8, 2026·High
- Medline Industries, LP — Class II recall: Medline Convenience kits containing recalled Swan-Ganz Catheters OPEN HEART…
July 8, 2026·High
Other enforcement types
Sourced from openFDA public enforcement data. Not legal or regulatory advice. Report an error via /contact.