PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

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

Total recalls
41,070
Top agency
FDA Devices
Years covered
2000–2026
Compiled from official public sources by the publisher.
Check a product → All categories

Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
total recalls
#1 of 12
category rank by events
9%
graded high-severity
FDA Devices
top issuing agency

Where Medical Devices sits among all 12 categories

Distinct recall-event inventory across every PlainRecalls product category. Medical Devices is marked; archive size reflects reporting volume, not inherent product danger.

Medical Devices vs all categories by recall count

Where this category's archive sits among every tracked product class

41,070 1st of 12 the highest of 12 categories

Categories, banded by distinct recall-event inventory

Each bar is a band; taller bars hold more categories. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-10-01

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-10-01. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-10-01.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 216 of 822

FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2225

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2190

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2187

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2214

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2186

Cardinal Health 200, LLC
FDA Devices Low Jan 25, 2023

Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels

Abbott Laboratories
FDA Devices Low Jan 25, 2023

R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Controls L, N, and H; (3) CBC-3D for Mythic 18 Hematology Control, REF 3D503RX, containing 2 x 2.0 mL each Controls L, N, and H; (4) CBC-3D For MINDRAY Hematology Control, REF 3D506, containing 2 x 3.0 mL each Controls L, N, and H; (5) CBC-3D For MINDRAY Hematology Control, REF 3D506US, contai

R & D Systems, Inc.
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2230

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-M4-XX-XXX-XXX

Bolton Medical Inc.
FDA Devices Moderate Jan 25, 2023

MobiCT-32 AIRO Mobile CT Scanner, Cat. No. MobiCT-32, mobile computed tomography system.

Mobius Imaging, LLC
FDA Devices Moderate Jan 25, 2023

RELAY PRO, THORACIC STENT-GRAFT SYSTEM, REF 28-N4-XX-XXX-XXX

Bolton Medical Inc.
FDA Devices Moderate Jan 25, 2023

Vasoshield Syringe Packs, Model VH-5001

Maquet Cardiovascular, LLC
FDA Devices Critical Jan 25, 2023

Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-36, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-32, 0998-UC-0800-33, 0998-UC-0800-34, 0998-UC-0800-35, 0998-UC-0800-36, 0998-UC-0800-45, 0998-UC-0800-52, 0998-UC-0800-53, 0998-UC-0800-55, 0998-UC-0800-65.

Datascope Corp.
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2228

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2213

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2211

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Hemopro 2 with Vasoshield, Model VH-4001

Maquet Cardiovascular, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2191

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2232

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2226

Cardinal Health 200, LLC
FDA Devices Critical Jan 25, 2023

SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.

Cardiac Assist, Inc
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2229

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 Fr, REF JP-2221

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

AXIOM Luminos Agile

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2216

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 24 Fr, REF JP-2234

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 7 mm, REF JP-2210

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 19 Fr, REF JP-2231

Cardinal Health 200, LLC
FDA Devices Moderate Jan 25, 2023

AXIOM Luminos TF, AXIOM Iconos R100, AXIOM Iconos R200 and AXIOM Luminos dRF

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 10 mm, REF JP-2215

Cardinal Health 200, LLC
FDA Devices Critical Jan 25, 2023

Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85, 0998-UC-0800-75, 0998-UC-0800-83, 0998-UC-0800-85.

Datascope Corp.
FDA Devices Moderate Jan 25, 2023

Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2188

Cardinal Health 200, LLC
FDA Devices Critical Jan 18, 2023

Philips Trilogy 100 Ventilator, Model Numbers 1054260, 1054096, U1054260, U1054260B, 1054260B, CA1054096B, BT1054260, 1054096B, R1054260, RSL1054260, CA1054096, R1054260B, R1054655TPV, AU1054096, AU1054096B, 1054096B, 1054097, BR1054096, LA1054096, CN1054096, KO1054096, KR1054096, R1054655TP, R1054655B, 1054655, 1054655TPV, 1054655TP, 1054655B

Philips Respironics, Inc.
FDA Devices Moderate Jan 18, 2023

McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

Vanta/Seqenita LT Clinician Programmer Application, Neurostimulation systems for pain therapy, Model Number CT900C

Medtronic Neuromodulation
FDA Devices Moderate Jan 18, 2023

Pediatric Craniotome Ref:CRANI-P-G1

The Anspach Effort, Inc.
FDA Devices Moderate Jan 18, 2023

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Covidien, LLC
FDA Devices Moderate Jan 18, 2023

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

cobas infinity central lab, Material Number 07154003001

Roche Diagnostics Operations, Inc.
FDA Devices Moderate Jan 18, 2023

Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium

The Anspach Effort, Inc.
FDA Devices Moderate Jan 18, 2023

IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in monitoring patients who have undergone thyroidectomy. Catalog # L2KTY2(D) Siemens Material Number (SMN): 10381647

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Jan 18, 2023

7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium

The Anspach Effort, Inc.
FDA Devices Moderate Jan 18, 2023

Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile

Stradis Healthcare
FDA Devices Moderate Jan 18, 2023

CoreLink LLC, FLXFIT 15, 32MM X 8MM, CAGE, REF: AT3208

CoreLink LLC
FDA Devices Moderate Jan 18, 2023

Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.

Stradis Healthcare

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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.