PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
total recalls
9%
graded high-severity
FDA Devices
top issuing agency
2000–2026
years covered

Medical Devices recalls by year

2000–2026

0 1000 2000 3000 4000 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 2025 2026 2576 3437 2649 3803 3003 3209 2356 2247 2606 3417 2982 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 2026

Severity distribution

Graded records only

recalls
Source FDA / CPSC severity classification

Recalls by issuing agency

recalls
Source PlainRecalls index of federal feeds

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 131 of 808

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL6 (5PK), REF H74908526252; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IM 125CM (5PK), REF H749085262402; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO IMC (5PK), REF H749085262032; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR3.5 (5PK), REF H74908526012; cardiac catheter

Boston Scientific Corporation

FDA Devices Moderate May 22, 2024

Spectrum IQ Infusion pump, Product Code 357009

Baxter Healthcare Corporation

FDA Devices Moderate May 22, 2024

Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardi…

Medtronic Perfusion Systems

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG3.5 (5PK), REF H749085262522; cardiac catheter

Boston Scientific Corporation

FDA Devices Moderate May 22, 2024

VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasm…

QUIDELORTHO

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO RCB (5PK), REF H749085261902; cardiac catheter

Boston Scientific Corporation

FDA Devices Moderate May 22, 2024

EchoTip¿ Ultra Endoscopic Ultrasound Access Needle, ECHO-19, G31520

Cook Medical Incorporated

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL3.5 (5PK), REF H74908526212; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FR5 125CM (5PK), REF H749085262302; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO WR (5PK), REF H74908526502; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO JIG4 (5PK), REF H749085262532; cardiac catheter

Boston Scientific Corporation

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO FL4 125CM (5PK), REF H749085262202; cardiac catheter

Boston Scientific Corporation

FDA Devices Moderate May 22, 2024

Medtronic Arterial Cannulae packaged as: a) DLP¿ Curved Metal Tip Arterial Cannula 20 Fr., Model Number 80020; b) DLP¿ Curved Metal Tip Arterial…

Medtronic Perfusion Systems

FDA Devices Critical May 22, 2024

Expo 5F Selective Angiographic Catheters, MODEL - 5F EXPO CLS3 (5PK), REF H74908526573A2; cardiac catheter

Boston Scientific Corporation

FDA Devices Moderate May 22, 2024

Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venou…

Medtronic Perfusion Systems

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: …

Angiodynamics, Inc.

FDA Devices Low May 15, 2024

Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human…

Randox Laboratories Ltd.

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Produc…

Angiodynamics, Inc.

FDA Devices Critical May 15, 2024

BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F040…

Hologic, Inc

FDA Devices Moderate May 15, 2024

Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended Tabletop, REF: 03400010, used with the Intelli-C X-ray system

NRT X-RAY A/S

FDA Devices Critical May 15, 2024

Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-707327; The TwinTube sample line 240cm is used in the Vyntus CPX. The TwinTu…

Vyaire Medical, Inc.

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H78710…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number:…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. …

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TLF-DS 45 40-S TLF-DS 45 45-S TLF-DS 55 30-S TLF-DS 55 35-S TLF-DS 55 …

SPINEART SA

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. …

Angiodynamics, Inc.

FDA Devices Critical May 15, 2024

t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

Tandem Diabetes Care, Inc.

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 32 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Pr…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: …

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml lyophilized human based serum covering 38 commonly used clinical chemist…

Randox Laboratories Ltd.

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 28CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Produ…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: …

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Innova IGS 5, computed tomography x-ray system

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Produc…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

5000 Compact Series Ultrasound Systems, Product/REF: 5500 CV/795141, 5500 P/795143, 5500 W/795144, 5500 G/795145, and Product/REF: 5300 W/795146, 530…

Philips Ultrasound, Inc.

FDA Devices Moderate May 15, 2024

GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems

GE Medical Systems, SCS

FDA Devices Moderate May 15, 2024

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product…

Angiodynamics, Inc.

FDA Devices Moderate May 15, 2024

Baxter Spectrum IQ Infusion Pump, Product Code 3570009

Baxter Healthcare Corporation

FDA Devices Critical May 15, 2024

Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the StealthStation System as an aid for locating anatomical structu…

Medtronic Navigation, Inc.

FDA Devices Moderate May 15, 2024

Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, stabilization and rigid fixation of the bony areas of the cranial skeleto…

Stryker Leibinger GmbH & Co. KG

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

Category data as of Jul 2, 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 Jul 2, 2026.