PlainRecalls

Product category · Updated Jul 29, 2026

Medical Devices recalls

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

Total recalls
40,910
Top agency
FDA Devices
Years covered
2000–2026
Compiled from official public sources by the editorial process.
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.

  • 40,910 total recalls
  • #1 of 12 among categories
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

According to PlainRecalls' category ranking (distinct recall events, same sort as /category), Medical Devices is #1 of 12 (1st of 12) with 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.

40,910
total recalls
#1 of 12
category rank by events
9%
graded high-severity
FDA Devices
top issuing agency

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 1787

Source: FDA · CPSC · NHTSA As of Jul 29, 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 234 of 819

FDA Devices Moderate Sep 28, 2022

Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples…

Diversatek Healthcare
FDA Devices Moderate Sep 28, 2022

PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

Ethicon, Inc.
FDA Devices Moderate Sep 28, 2022

BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106

CAREFUSION
FDA Devices Moderate Sep 28, 2022

The Randox Serology I Positive Control contains the following analytes in human based plasma: Anti HIV 1/2, Anti HTLV 1/2, Anti HCV, HBsAg, Anti HBc,…

Randox Laboratories Ltd.
FDA Devices Moderate Sep 28, 2022

AquaC UNO H [120V, 60Hz, 1000VA, US-Version - a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-10VA-1…

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Sep 28, 2022

Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum Ref: FT007

Associates of Cape Cod, Inc.
FDA Devices Moderate Sep 28, 2022

Puritan Bennett 560 Ventilator, PB560, CFN 4096600

Covidien Llc
FDA Devices Moderate Sep 28, 2022

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular sup…

Maquet Medical Systems USA
FDA Devices Moderate Sep 28, 2022

BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166

CAREFUSION
FDA Devices Moderate Sep 28, 2022

AquaC UNO H [120V, 60Hz, 1700VA, US-Version- a reverse osmosis unit intended for use with hemodialysis systems. Fresenius Part Number: 24-0970-1 V…

Fresenius Medical Care Holdings, Inc.
FDA Devices Moderate Sep 28, 2022

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular sup…

Maquet Medical Systems USA
FDA Devices Moderate Sep 28, 2022

BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular sup…

Maquet Medical Systems USA
FDA Devices Moderate Sep 28, 2022

ORCA FOAM STANDARD CUBE 10x10x10 mm, Absorbable Gelatin Sponge Hemostat, USP, REF ORCA FOAM

GELITA MEDICAL GMBH
FDA Devices Moderate Sep 28, 2022

BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular sup…

Maquet Medical Systems USA
FDA Devices Moderate Sep 28, 2022

BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059

CAREFUSION
FDA Devices Moderate Sep 28, 2022

BD MaxGuard Extension Set with 4-way stopcock, REF: M4058

CAREFUSION
FDA Devices Moderate Sep 28, 2022

BD MaxGuard Extension Set, REF: ME1069

CAREFUSION
FDA Devices Moderate Sep 28, 2022

Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System

Paragon 28, Inc.
FDA Drug Moderate Sep 21, 2022

MIC/B12/L-Carn (HD) 35/35/35/1/35 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

MIC/B12 25/50/50/1 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

Sermorelin Acetate 1 MG/ML Injectable, 9 ML syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

Semaglutide/Cyanocobalamin 5/2 MG/ML Injectable, 0.2 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

L-Carnitine 500 mg/mL Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Drug Moderate Sep 21, 2022

QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

Carolina Infusion
FDA Devices Moderate Sep 21, 2022

6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.

ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter position…

Cook Incorporated
FDA Devices Low Sep 21, 2022

Helix Elite Inactivated Standard, labeled as: a. Inactivated SARS-CoV-2 B.1.1.7 Whole Virus, REF HE0071N; b. Inactivated SARS-CoV-2 B.1.351 Who…

Microbiologics Inc
FDA Devices Moderate Sep 21, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b. ACUMA…

Exactech, Inc.
FDA Devices Moderate Sep 21, 2022

MicroClave Clear Neutral Connector; MicroClave Clear Connector; MicroClave Clear Neutral Connector, Approx Priming Volume: 0.04 mL. Accessory…

ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022

Pinnacle3 Radiation Therapy Planning System, Model numbers 870231 and 870237.

Philips Medical Systems (Cleveland) Inc
FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN):RLPC-35-180 ORDER NUMBER (GPN) G07516. For vascular catheter positioning and e…

Cook Incorporated
FDA Devices Moderate Sep 21, 2022

ZAP-X Radiosurgery System

Zap Surgical Systems
FDA Devices Moderate Sep 21, 2022

Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and e…

Cook Incorporated
FDA Devices Moderate Sep 21, 2022

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022

GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH +5MM LAT LINER 15 DEG 36MM ID, SIZE H, REF 138-36-08 …

Exactech, Inc.
FDA Devices Moderate Sep 21, 2022

MicroClave Clear Neutral Connector. A bidirectional connector used as an accessory to an intravascular catheter placed in the vein or artery.

ICU Medical, Inc.
FDA Devices Moderate Sep 21, 2022

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter position…

Cook Incorporated

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.

Food

25,473 recalls →

Drugs & Medications

14,437 recalls →

Vehicles

8,940 recalls →

Children & Baby Products

4,007 recalls →

Household Products

3,567 recalls →

Dietary Supplements

2,016 recalls →

Data sources

Category data as of Jul 29, 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 29, 2026.