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
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 418 of 819

FDA Devices Moderate May 29, 2019

V-TEK", standard-countersink, cannulated, round shaft, Item Number 28.66.110

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill for 2.7mm screw, 2x120mm, AO, Item Number ST502015212

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill for 2.7mm screw, 2x100mm, AO, Item Number 502015208

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill for 3.5mm screw, 2.5x125mm, stryker, Item Number 502015218

Zimmer GmbH

FDA Devices Moderate May 29, 2019

AURIGA XL 4007 GENERAL - ZERO COST SYSTE UPN: FS4007GZ0 Product Usage: The Auriga XL 4007 Laser System and the Auriga 30 Laser System includ…

Boston Scientific Corporation

FDA Devices Moderate May 29, 2019

CBS 4.0 countersink, cannulated, 30mm stop, AO, Item Number 503004353

Zimmer GmbH

FDA Devices Moderate May 29, 2019

NeuViz 128 Multi-slice CT Scanner System Product Usage: The Multi-Slice CT Scanner System can be used as a whole body computed tomography x-ray sy…

Neusoft Medical Systems Co., Ltd.

FDA Devices Moderate May 29, 2019

Drill, cannulated, 2.5x95mm, round shaft, Item Number ST502015620

Zimmer GmbH

FDA Devices Moderate May 29, 2019

ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0

CooperSurgical, Inc.

FDA Devices Moderate May 29, 2019

Drill, 2.7x125mm, AO, Item Number 502015217

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Drill, 26mm stop, 1.4x81mm, AO, Item Number 502015124

Zimmer GmbH

FDA Devices Moderate May 29, 2019

Lipid Panel test strips, REF 1710, also private labeled under Henry Schein as REF 570-0414

Polymer Technology Systems, Inc.

FDA Devices Moderate May 29, 2019

Drill, cannulated, 4x150mm, AO, Item Number 502015403

Zimmer GmbH

FDA Devices Moderate May 22, 2019

MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S

Compass Health Brands (Corporate Office)

FDA Devices Critical May 22, 2019

Straight Intraluminal Staplers, 25 mm diameter, Model SDH25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…

Ethicon Endo-Surgery Inc

FDA Devices Low May 22, 2019

ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for…

Abbott Laboratories

FDA Devices Moderate May 22, 2019

Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technolog…

Shippert Medical Technologies

FDA Devices Critical May 22, 2019

Straight Intraluminal Staplers, 33 mm diameter, Model SDH33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…

Ethicon Endo-Surgery Inc

FDA Devices Low May 22, 2019

ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation o…

Abbott Laboratories

FDA Devices Critical May 22, 2019

Endoscopic Curved Intraluminal Stapler, 21 mm diameter, Model ECS21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 22, 2019

SureSigns VS3 NBP Temp, Product Number 863070. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Philips North America, LLC

FDA Devices Low May 22, 2019

ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are for the calibration of the Alinity i analyzer when used for th…

Abbott Laboratories

FDA Devices Moderate May 22, 2019

Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003

Moller Vital

FDA Devices Moderate May 22, 2019

CS011 GNR PNA FISH Control Slide, manufactured as a component of the CS011-10 GNR PNA FISH Control Slide kit . In-Vitro Diagnostic The CS011 GNR…

Opgen Inc

FDA Devices Moderate May 22, 2019

Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended …

PENTAX of America Inc

FDA Devices Moderate May 22, 2019

M200 Fall Monitoring System

Stanley Security Solutions Inc

FDA Devices Moderate May 22, 2019

BD Veritor System Reader -In Vitro Diagnostic for use with BD Veritor System Test Kit Devices Catalog Number: 256055

Becton Dickinson & Co.

FDA Devices Moderate May 22, 2019

Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm name on the label is Shippert Medical Technologi…

Shippert Medical Technologies

FDA Devices Moderate May 22, 2019

Artis Zeego (material 10280959) - Product Usage: AXIOM Artis zee and Q/ Q.zen is a family of dedicated angiography systems developed for single and b…

Siemens Medical Solutions USA, Inc

FDA Devices Moderate May 22, 2019

Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the …

Abbott Ireland Diagnostics Division

FDA Devices Low May 22, 2019

Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is intended for use as an assayed quality control serum to monitor th…

Abbott Laboratories

FDA Devices Moderate May 22, 2019

Abbott Alinity ci-series System Control Module software version 2.5.1; LN 3R70-01 with the following hardware: Level Sensor, Bulk Solution; 04S68-01,…

Abbott Gmbh & Co. KG

FDA Devices Critical May 22, 2019

Endoscopic Curved Intraluminal Stapler, 33 mm diameter, Model ECS33A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…

Ethicon Endo-Surgery Inc

FDA Devices Low May 22, 2019

ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of te…

Abbott Laboratories

FDA Devices Moderate May 22, 2019

SureSigns VS3 NBP, SpO2, Temp, Product Number 863073. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Philips North America, LLC

FDA Devices Critical May 22, 2019

Straight Intraluminal Staplers, 29 mm diameter, Model SDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 22, 2019

SureSigns VS3 NBP, SpO2, Temp, Rec, Product Number 863074. For monitoring the physiological parameters of patients (NBP, SpO2 & Temperature).

Philips North America, LLC

FDA Devices Moderate May 22, 2019

MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S

Compass Health Brands (Corporate Office)

FDA Devices Moderate May 22, 2019

Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for …

Arrow International Inc

FDA Devices Moderate May 22, 2019

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588 The electronic gas blender provides control…

Terumo Cardiovascular Systems Corporation

FDA Devices Critical May 22, 2019

Curved Intraluminal Staplers, 21 mm diameter, Model CDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…

Ethicon Endo-Surgery Inc

FDA Devices Critical May 22, 2019

Endoscopic Curved Intraluminal Stapler, 25 mm diameter, Model ECS25A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers…

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 22, 2019

MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S

Compass Health Brands (Corporate Office)

FDA Devices Moderate May 22, 2019

Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is intended to b…

PENTAX of America Inc

FDA Devices Moderate May 22, 2019

Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Usage: The C2 CryoBalloon Ablation System is inten…

PENTAX of America Inc

FDA Devices Moderate May 22, 2019

Power-LOAD Cot Fastening System, Model #6390, Catalog #6390-000-000

Stryker Medical Division of Stryker Corporation

FDA Devices Moderate May 22, 2019

Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00…

R82 A/S

FDA Devices Critical May 22, 2019

Straight Intraluminal Staplers, 21 mm diameter, Model SDH21A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers availab…

Ethicon Endo-Surgery Inc

FDA Devices Critical May 22, 2019

Curved Intraluminal Staplers, 29 mm diameter, Model CDH29A The Ethicon Endo-Surgery Intraluminal Staplers (ILS) are anastomotic staplers available…

Ethicon Endo-Surgery Inc

FDA Devices Moderate May 22, 2019

MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S

Compass Health Brands (Corporate Office)

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 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.