Product category · Updated Jun 3, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 records graded for severity, 9% are high-severity. Most are issued by FDA Devices. Counts reflect market size and reporting activity, not a product's inherent danger.
- 40,478 total recalls
- 40.4% of the archive
- 9% graded high-severity
- FDA Devices top agency
Category snapshot
Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.
- 40,478
- total recalls
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
- 2000–2026
- years covered
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,549
High severity
3,549 recalls
- Moderate
Moderate
35,871 recalls
- Lower severity 1,058
Lower severity
1,058 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 882
FDA Drug
882 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 59
FDA Food
59 recalls
Counts reflect market size and reporting activity, not inherent danger — we do not rank products by risk from raw recall volume.
Recalls in Medical Devices
Newest first · Page 27 of 810
Brand Name: AART Malar Implant Product Name: Malar Implant Model/Catalog Number: 401-202-5 Malar Implant style 2 size 2 left UDI-DI code: B490401…
DSAART LLC
Cardiosave Hybrid
Datascope Corp.
Brand Name: Rocket Product Name: Rocket 20Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-20-PK Software Version: N/A Product D…
Rocket Medical Plc
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Fresenius Kabi USA, LLC
5008X CAREsystem +CLiC +CDX;
Fresenius Medical Care Holdings, Inc.
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-12-SG Software Version: N/A Produc…
Rocket Medical Plc
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk + sputum transfer device, for WASP* *Compatible with Copan s WASP (Walk-Away Spe…
Copan Italia
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-18-PK Software Version: N/A Product D…
Rocket Medical Plc
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Si…
DSAART LLC
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012…
GE Medical Systems China Co., Ltd.
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Cepheid
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Zimmer Surgical Inc
Brand Name: AART Chin Implant Product Name: Chin Implant Model/Catalog Numbers: 400-0101 Chin Implant style 1 size 1 UDI-DI code: B490400101 4…
DSAART LLC
Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54544-12-PK Product Description: Chest tube …
Rocket Medical Plc
Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF…
SEASPINE ORTHOPEDICS CORPORATION
InPen App, Model/CFN Number: MMT-8061 (Android Users)
Medtronic MiniMed, Inc.
SCISSORS, OR, SHARP/BLUNT, 5.5", STERILE, Item Number DYND04000
Medline Industries, LP
1ml of DTT in liquid phase, in PET tube with capture cap, in bulk
Copan Italia
FORCEP, STD STR, STERILE KELLY, 5.5 IN, Item Number DYNJ04048
Medline Industries, LP
Intelerad InteleShare software, with ProViewer component
DICOM Grid, Inc.
Brand Name: AART Pectoral Implant Product Name: Pectoral Implant Model/Catalog Number: 500-106-5 Pectoral Implant style 1 size 6 left UDI-DI code…
DSAART LLC
Brand Name: AART Gluteal Implant Product Name: Gluteal Implant Model/Catalog Numbers: 501-101 - Gluteal Implant style 1 size 1 UDI-DI code: B4905…
DSAART LLC
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
AVID Medical, Inc.
GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S
GE Medical Systems China Co., Ltd.
Brand Name: Rocket Product Name: Rocket 18Fg Seldinger Catheter with Safety Guard Model/Catalog Number: R54544-18-SG Software Version: N/A Produc…
Rocket Medical Plc
Amp Fit Recalls AMP Smart Fitness Machines Due to Laceration and Serious Injury Hazard
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medline Industries, LP
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Datascope Corp.
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the…
Steris Corporation
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in th…
Steris Corporation
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
C.R. Bard Inc
Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0¿, 9W x 23L x…
Orthofix U.S. LLC
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
C.R. Bard Inc
Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Imm…
Beckman Coulter, Inc.
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Medline Industries, LP
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus F…
Cardinal Health 200, LLC
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pati…
Draeger, Inc.
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Datascope Corp.
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
C.R. Bard Inc
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patie…
Draeger, Inc.
Quick Strip Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25500QS
Medline Industries, LP
Fur Friends Plastic Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON256133QS
Medline Industries, LP
Azurion R3.0. Model Number 722234. Commercial Name: Azurion 7 M20. INTERVENTIONAL FLUOROSCOPIC XRAY SYSTEM
Philips North America
ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient …
Draeger, Inc.
Brand Name: CONSTRUX" Mini Ti Spacer System Product Name: CONSTRUX" Mini Ti Spacer System Model/Catalog Number: 37-6005SP 12mm W X 12mm L, 5mm H, …
Orthofix U.S. LLC
CURAD Germ-Shield Touch-Free Fabric Bandages, Sterile, 0.75" x 3", 30/Box, Medline Item Number CUR1930F
Medline Industries, LP
Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX" Mini PTC Spacer System Model/Catalog Number: 37-3106SP 12mm W X 12mm L, 6mm H…
Orthofix U.S. LLC
Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T,
Bard Peripheral Vascular Inc
Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography
GE Medical Systems, LLC
Stryker Arise 1000EX mattress, Part Number 2236000000
Stryker Medical Division of Stryker Corporation
What to do with this
Monitoring medical devices? Start here.
- Check a specific product against the full federal archive before you use or buy it. Recall checker
- Most medical devices recalls come from FDA Devices — browse that agency's full feed. FDA Devices recalls
- Sort the whole archive by severity to see the highest-risk active recalls first. Rankings
Recall categorization follows the issuing agency's product taxonomy; always confirm specifics on the official notice.
Nearby categories
Adjacent product categories that share hazard patterns or regulatory oversight.
Data sources
- Source: FDA — openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls
- Source: NHTSA — National Highway Traffic Safety Administration Recalls (vehicles & equipment)
Category data as of Jun 3, 2026.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records — no number is typed in by an editor. Category counts and the year trend are computed across the full archive for medical devices. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of Jun 3, 2026.