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 397 of 819

FDA Devices Moderate Aug 28, 2019

MAGNETOM Skyra magnetic resonance diagnostic devices Model # 10432915

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Aug 28, 2019

Kit BD Max CT/GC/TV; Catalog # 442970

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

Thoratec HeartMate 3 LVAS Implant Kit, Sterile, REF 106524/106524US, RX only, Left Ventricular Assist System

Thoratec Corp.
FDA Devices Moderate Aug 28, 2019

Kit BD Max Cdiff EU; Catalog # 442555

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

MAGNETOM Aera magnetic resonance diagnostic devices Model # 10432914

Siemens Medical Solutions USA, Inc
FDA Devices Moderate Aug 28, 2019

Luer Lock Set - Catalog # MPC-125, for IV administration sets.

Molded Products Inc
FDA Devices Moderate Aug 28, 2019

BD Vacutainer Lithium HeparinN 75 USP Units Blood Collection Tubes, Catalog Number 367884

Becton Dickinson & Company
FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (26mm) 9630TF26 UDI:00690103201253

Edwards Lifesciences, LLC
FDA Devices Moderate Aug 28, 2019

TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extens…

TiSport, Llc
FDA Devices Moderate Aug 28, 2019

ABL90 FLEX Analyzer REF 393090 UDI:05700693930909

Radiometer America Inc
FDA Devices Moderate Aug 28, 2019

Kit BD Max GC RT PCR Assay; Catalog # 443486

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

BD Vacutainer LH (Lithium Heparin) 102 I.U. Plus Blood Collection Tubes, Catalog Number 368886

Becton Dickinson & Company
FDA Devices Moderate Aug 28, 2019

BD Vacutainer PST Blood Collection Tubes, Catalog Number 368035, 368036

Becton Dickinson & Company
FDA Devices Moderate Aug 28, 2019

Kit BD Max Enteric Parasite Panel EU; Catalog # 442960

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

BD Vacutainer Lithium HeparinN (LH) 158 USP Units Blood Collection Tubes, Catalog Number 367880

Becton Dickinson & Company
FDA Devices Moderate Aug 28, 2019

N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins in serum, plasma, urine and CSF. Siemens Materi…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Aug 28, 2019

Kit BD Max ExK DNA 2 USA; Catalog # 442819

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

BD Vacutainer PST Gel and Lithium HeparinN (LH) Blood Collection Tubes, Catalog Number 367963

Becton Dickinson & Company
FDA Devices Moderate Aug 28, 2019

ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.

Aniara Diagnostica LLC
FDA Devices Moderate Aug 28, 2019

Kit BD Max Enteric Bacterial Panel EU; Catalog # 442963

Becton Dickinson & Co.
FDA Devices Moderate Aug 28, 2019

BD Vacutainer PST Gel and Lithium HeparinN (LH) 65 Units Blood Collection Tubes, Catalog Number 367961

Becton Dickinson & Company
FDA Devices Moderate Aug 28, 2019

IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Aug 28, 2019

Kit BD Max MRSA XT; Catalog # 443461

Becton Dickinson & Co.
FDA Devices Critical Aug 28, 2019

Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239

Edwards Lifesciences, LLC
FDA Devices Low Aug 28, 2019

MICRO-TEMP LT System, Model 749- Localized Heat Therapy System is intended to warm a patient's body part through conductive heat transfer.

Cincinnati Sub-Zero Products LLC, a Gentherm Company
FDA Devices Moderate Aug 28, 2019

DeRoyal Enteral Safe Feeding Tubes: a) REF 54-2450R, 5 FR x 24" Polyurethane b) REF 54-2465R, 6.5 FR x 24" Polyurethane c) REF 54-2480R, 8 FR x 24…

DeRoyal Industries Inc
FDA Drug Moderate Aug 21, 2019

INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 71…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL 155 MG/ 250 ml NS IVPB; DOCETAXEL 110 mg / 250 ml NS IVPB; DOCETAXEL 15…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL Fluorouracil 3920 MG QS 92 ML 0.9% NACL Fluorouracil 3760 mg QS 100 ml N…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml 0.9% NACL; Cisplatin 44 MG QS 500 ml NS IVPB; Cisplatin 40 MG / 500 ml …

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-72…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IVPB; Gemcitabine 1290 MG /250 ML NS IVPB; Gemcitabine 460 MG / 250 ML NS …

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCOVORIN 300 MG / 50 ml D5W IVPB; LEUCOVORIN 840 MG / 250 ml NS IVPB; LEUCO…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; HERCEPTIN 553 MG / 250 ml NS IVPB; HERCEPTIN 305 MG / 250 ml NS IVPB; HER…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, N…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

VELCADE 2.1 mg / 0.84 ml SQ SYRINGE; VELCADE 2.5 MG/ 1 ML SUB-Q SYRINGE; VELCADE 2.2 MG/ 0.88 ML SUB-Q SYRINGE; VELCADE 2.6 MG (1.04 ML) Sub Q SYRING…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

TRASTUZUMAB 427 MG / 250 ml NS IVPB; TRASTUZUMAB 531 MG / 250 ML NS IVPB; TRASTUZUMAB 276 MG / 250 ML NS IVPB; TRASTUZUMAB 360 MG / 250 ML NS IVPB; T…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

InFLIXimab 300 mg / 250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLITAXEL 385 MG / 500 ML NS IVPB; PACLITAXEL 340 MG / 500 ML NS IVPB; PACLI…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; …

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

PERJETA 420 MG/250 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

IRINOTECAN 250 MG /500 ml D5W IVPB; IRINOTECAN 110 MG /250 ML D5W IVPB; IIRINOTECAN 250 MG/250 ML NS IVPB; IRINOTECAN 315 MG / 250 ML NS IVPB; IRINOT…

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

Infusion Options, Inc.
FDA Drug Moderate Aug 21, 2019

VINCRISTINE 1 MG /50 ML NS IVPB; VINCRISTINE 1.2 MG /50 ML NACL 0.9% IVPB; VINCRISTINE 1 MG / 1 ML IVP SYRINGE; VINCRISTINE 2 MG /100 ML D5W IVPB, Rx…

Infusion Options, 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.

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.