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.
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Medical Devices accounts for 40,910 recalls, about 39.3% of the federal recall archive, of which 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. 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
  • 39.3% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 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
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 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 190 of 819

FDA Devices Moderate Jul 12, 2023

PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL TMX428CP 220V, MODEL NUMBER 317-07929

Full Vision Inc
FDA Devices Moderate Jul 12, 2023

BD Synapsys Informatics Solution, Catalog Number 444150

Becton Dickinson & Co.
FDA Devices Moderate Jul 12, 2023

Custom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014

DeRoyal Industries Inc
FDA Devices Moderate Jul 12, 2023

Pilling LOWSLEY PROSTATIC TRACTOR STR, REF 243201; retractor

TELEFLEX LLC
FDA Devices Critical Jul 12, 2023

TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)

GE Healthcare Finland Oy
FDA Devices Moderate Jul 12, 2023

PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL TMX428 110V, MODEL NUMBER 317-07926

Full Vision Inc
FDA Devices Moderate Jul 12, 2023

Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219

DeRoyal Industries Inc
FDA Devices Moderate Jul 12, 2023

SurgiMend; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 1.0 5x6 cm, 1.0 6x12 cm, 1.0 10x10 cm, 1.0 10x15 cm, 1.0 10x20 cm, 1.0 16x2…

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

SurgiMend 4.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, 25x40 cm, 20x30 cm, 10x25 cm, 20x0…

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes 20x25 cm (1:1), 3x3 cm (2:1), 4x4 cm (2:1), 5x5 cm (2:1), 6x6 cm (2:1), 8x12 cm (2:1), and 8…

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

Custom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) …

DeRoyal Industries Inc
FDA Devices Moderate Jul 12, 2023

KLS Martin Battery Pack, REF: KLS BP 001, and KLS BP 040 (bulk case of 40), used in conjunction with the KLS Martin MaxDriver

Pro-Dex Inc
FDA Devices Moderate Jul 12, 2023

Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M1050205, d. M1135822, e. M1145475, f. M1145476…

DATEX--OHMEDA, INC.
FDA Devices Critical Jul 12, 2023

TruSignal Adult/Pediatric Sensor; Oximeter, Ear: a) REF TS-AP-10, 10 pcs; b) REF TS-AP-25, 25 pcs

GE Healthcare Finland Oy
FDA Devices Moderate Jul 12, 2023

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement…

Waldemar Link GmbH & Co. KG (Mfg Site)
FDA Devices Moderate Jul 12, 2023

BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107-97-201; BD Pyxis CII Safe, Software: V7, REF: 107-223, 107-224, 111-191, 111-192, 111-193, …

CareFusion 303, Inc.
FDA Devices Critical Jul 12, 2023

Quidel Triage Cardiac Panel: REF: 97000HS, 97021HS (Troponin I), 97022HS (CK-MB and Troponin I), 97000HSEU, 97000HSEUJP, 97000HZ01, 97000QIL. Lots T1…

QUIDEL CARDIOVASCULAR INC
FDA Devices Moderate Jul 12, 2023

Trilogy Evo, Evo Clinical Korean (1137823) and Evo Caregiver Korean (1137853) Instructions for Use

Philips Respironics, Inc.
FDA Devices Moderate Jul 12, 2023

SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20x30 cm, 20x2…

TEI Biosciences, Inc.
FDA Devices Low Jul 12, 2023

NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transpo…

NeuMoDx Molecular Inc
FDA Devices Moderate Jul 12, 2023

Beside panel FRU (Field Replacement Units) Kits

DATEX--OHMEDA, INC.
FDA Devices Critical Jul 12, 2023

TruSignal Wrap Sensor, REF TS-W-D; Oximeter

GE Healthcare Finland Oy
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL GE T2100-ST2 220V, MODEL NUMBER 317-07927GE

Full Vision Inc
FDA Devices Critical Jul 12, 2023

TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-N; Oximeter

GE Healthcare Finland Oy
FDA Devices Critical Jul 12, 2023

TruSignal Integrated Ear Sensor with GE Connector REF TS-E2-GE; Oximeter, Ear

GE Healthcare Finland Oy
FDA Devices Moderate Jul 12, 2023

TissueMend; Advanced Soft Tissue Repair Matrix; Rx Only; Sizes 5x6 cm, 6x10 cm, and 3x3 cm.

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650-0002-901, 6650-0094-901, 6650-0001-9901, 6650-00…

DATEX--OHMEDA, INC.
FDA Devices Critical Jul 12, 2023

TruSignal Ear Sensor, REF TS-E-D; Oximeter

GE Healthcare Finland Oy
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL GE T2100-ST1 110VV, MODEL NUMBER 317-07926GE

Full Vision Inc
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL TMX428 220V, MODEL NUMBER 317-07927

Full Vision Inc
FDA Devices Moderate Jul 12, 2023

SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm …

TEI Biosciences, Inc.
FDA Devices Moderate Jul 12, 2023

TRACKMASTER, TREADMILL TMX428CP 110V, MODEL NUMBER 317-07928

Full Vision Inc
FDA Devices Moderate Jul 12, 2023

BETTA LINK SR REUSABLE FISHMOUTH GUIDE-Intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or…

T.A.G. MEDICAL PRODUCTS CORPORATION, LTD.
FDA Devices Moderate Jul 12, 2023

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement…

Waldemar Link GmbH & Co. KG (Mfg Site)
FDA Devices Critical Jul 5, 2023

Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382035

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382055

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082075

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery

Megadyne Medical Products, Inc.
FDA Devices Critical Jul 5, 2023

Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 150055

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090

TELEFLEX LLC
FDA Devices Critical Jul 5, 2023

Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380065

TELEFLEX LLC
FDA Devices Moderate Jul 5, 2023

Integre Pro Yellow LP561, Integre Pro Yellow LP6RY, Integre Pro Scan Green LP6G, Integre Pro Green LP5532 Spare, Optics Bench V2, L2G/LP6G

Ellex Medical Pty Ltd.

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.