Product category · Updated Mar 18, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Category snapshot
Medical Devices accounts for 27,372 recalls — about 32.6% of the 83,949-record federal archive, with 2,343 graded high-severity, most issued by FDA Devices.
- 27,372
- 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 2,343
High severity
2,343 recalls
- Moderate
Moderate
24,310 recalls
- Lower severity 719
Lower severity
719 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
26,000 recalls
- FDA Drug 880
FDA Drug
880 recalls
- CPSC 441
CPSC
441 recalls
- FDA Food 51
FDA Food
51 recalls
Recalls in Medical Devices
Newest first · Page 9 of 548
FDA Devices Moderate Dec 31, 2025
Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800
AGFA Healthcare Corp.
FDA Devices Moderate Dec 31, 2025
KWIK-STIK 6-Pack, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325K
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
LYFO DISK, Campylobacter jejuni subsp. jejuni derived from ATCC 29428, Catalog Number 0325L
Microbiologics Inc
FDA Devices Moderate Dec 31, 2025
R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-100; The R¿sch-Uchida Transjugular Liver Access Set is intended for tran…
Cook Incorporated
FDA Devices Moderate Dec 31, 2025
Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815609340 Software Version: …
Zimmer, Inc.
FDA Devices Moderate Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Cepheid
FDA Devices Moderate Dec 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Smith & Nephew, Inc.
FDA Devices Low Dec 24, 2025
HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Instrumentation Laboratory
FDA Devices Moderate Dec 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100
Zimmer Surgical Inc
FDA Devices Moderate Dec 24, 2025
Hardware configuration of the BeneVision Central Monitoring System (CMS), marketed as BeneVision Distributed Monitoring System (DMS). Model Number: 1…
Mindray DS USA, Inc. dba Mindray North America
FDA Devices Moderate Dec 24, 2025
MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100)
PATH
FDA Devices Moderate Dec 24, 2025
Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3 different sizes (s…
Myofunctional Research Company USA
FDA Devices Moderate Dec 24, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories
FDA Devices Moderate Dec 24, 2025
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
AVID Medical, Inc.
FDA Devices Moderate Dec 24, 2025
Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A Product D…
Rocket Medical Plc
FDA Devices Moderate Dec 24, 2025
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
GE Healthcare GmbH
FDA Devices Moderate Dec 24, 2025
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
AVID Medical, Inc.
FDA Devices Low Dec 24, 2025
Cardiosave Rescue
Datascope Corp.
FDA Devices Critical Dec 24, 2025
GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012…
GE Medical Systems China Co., Ltd.
FDA Devices Moderate Dec 24, 2025
Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code: B490502103 5…
DSAART LLC
FDA Devices Moderate Dec 24, 2025
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
AVID Medical, Inc.
FDA Devices Moderate Dec 24, 2025
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
AVID Medical, Inc.
FDA Devices Moderate Dec 24, 2025
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
FDA Devices Low Dec 24, 2025
Cardiosave Hybrid
Datascope Corp.
FDA Devices Moderate Dec 24, 2025
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
FDA Devices Critical Dec 24, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Fresenius Kabi USA, LLC
FDA Devices Moderate Dec 24, 2025
5008X CAREsystem +CLiC +CDX;
Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Dec 24, 2025
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
FDA Devices Moderate Dec 24, 2025
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
FDA Devices Moderate Dec 24, 2025
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
FDA Devices Moderate Dec 24, 2025
Brand Name: AART Silicone Carving Implant Product Name: Silicone Carving Implant Model/Catalog Numbers: 600-601 - Silicone Carving Implant Style 6 Si…
DSAART LLC
FDA Devices Critical Dec 24, 2025
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.
FDA Devices Moderate Dec 24, 2025
Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10
Cepheid
FDA Devices Moderate Dec 24, 2025
Zimmer Dermatome AN, Model/Catalog Number: 88710100
Zimmer Surgical Inc
FDA Devices Moderate Dec 24, 2025
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
CPSC Moderate Dec 18, 2025
Amp Fit Recalls AMP Smart Fitness Machines Due to Laceration and Serious Injury Hazard
FDA Devices Moderate Dec 17, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 1" x 3", Medline Item Number NON25660QS
Medline Industries, LP
FDA Devices Moderate Dec 17, 2025
Cardiosave Rescue. Intra-Aortic Balloon Pump system.
Datascope Corp.
FDA Devices Moderate Dec 17, 2025
AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description: The AMSCO 7052HP Washer/Disinfector is intended for use in the…
Steris Corporation
FDA Devices Moderate Dec 17, 2025
AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description: The AMSCO 7053HP Washer/Disinfector is intended for use in th…
Steris Corporation
FDA Devices Moderate Dec 17, 2025
BD InLay Optima Ureteral Stent Kit Size: 6 Fr. x 30 cm, Ureteral Stent Kit REF 788630
C.R. Bard Inc
FDA Devices Low Dec 17, 2025
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
FDA Devices Moderate Dec 17, 2025
Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit REF 787614
C.R. Bard Inc
FDA Devices Moderate Dec 17, 2025
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.
FDA Devices Moderate Dec 17, 2025
Quick Strip Fabric Sterile Adhesive Bandages, 0.75" x 3", Medline Item Number NON25650QS
Medline Industries, LP
FDA Devices Moderate Dec 17, 2025
ChemoPlus gowns: Product Code Product Description CT5500T ChemoPlus Full Coverage Sleeve, Universal, Medium Blue, Non-sterile; CT5502T ChemoPlus F…
Cardinal Health 200, LLC
FDA Devices Critical Dec 17, 2025
ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the pati…
Draeger, Inc.
FDA Devices Moderate Dec 17, 2025
Cardiosave Hybrid. Intra-Aortic Balloon Pump system.
Datascope Corp.
FDA Devices Moderate Dec 17, 2025
BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm, Ureteral Stent Kit REF 788426
C.R. Bard Inc
FDA Devices Critical Dec 17, 2025
ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patie…
Draeger, Inc.
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 Mar 18, 2026.
Read our methodology — how this data is sourced, computed, and verified.
