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 publisher.
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

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

40,910 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 · NHTSA federal recall filings · 2026-08-23

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 480 of 819

FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, CO2 monitor Product Usage: The AirLife Resusc…

Vyaire Medical
FDA Devices Moderate May 16, 2018

ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604

Datascope Corporation
FDA Devices Moderate May 16, 2018

Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article Number 075.113

Straumann Manufacturing, Inc.
FDA Devices Moderate May 16, 2018

POWERPORT(R) ClearVUE(R) isp with Smooth Septum, 6F ChronoFlex(TM), Polyurethane Catheter, REF 1666362

Bard Peripheral Vascular Inc
FDA Devices Moderate May 16, 2018

BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966

Datascope Corporation
FDA Devices Moderate May 16, 2018

PICC Tray, Product Code: AMS-9093CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.
FDA Devices Moderate May 16, 2018

Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 16, 2018

PICC Insertion Tray, Product Code: AMS-7192CS-4 Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.
FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-120-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reserv…

Cook Inc.
FDA Devices Moderate May 16, 2018

BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01

Datascope Corporation
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector, PEEP valve Product Usage: The AirLife Resuscitation devices are manu…

Vyaire Medical
FDA Devices Moderate May 16, 2018

ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate in human serum and plasma (lithium heparin). Pro…

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 16, 2018

BEQ-TOP 22701, Catalog No. 701050790

Datascope Corporation
FDA Devices Moderate May 16, 2018

Capio CL; Model #M0068311350. Indicated for the placement of suture in a variety of Transvaginal procedures.

Boston Scientific Corporation
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, oxygen reservoir bag, pressure-relief valve Product Usage: The AirLife Resuscitation devices are manual…

Vyaire Medical
FDA Devices Moderate May 16, 2018

BEQ-TOP 38900 ECC PACK, Custom Tubing Kit, Catalog No. 701056368

Datascope Corporation
FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with Master Drug Library (Version 6) 35700BAXRE Product Usage: The Baxter Sigma Spectrum Infusion Pump with m…

Baxter Healthcare Corporation
FDA Devices Moderate May 16, 2018

BEQ-T 25502 1/4 Better Bladder , Custom Tubing Kit, Catalog No. 709000434

Datascope Corporation
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, PEEP valve Product Usage: The AirLife Resusci…

Vyaire Medical
FDA Devices Moderate May 16, 2018

BARD¿ BrachySource¿ Iodine125 radioactive seeds consist of a welded titanium capsule containing the I125 absorbed onto a nickel / copper-coated, gold…

Bard Brachytherapy, Inc.
FDA Devices Moderate May 16, 2018

BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01

Datascope Corporation
FDA Devices Moderate May 16, 2018

Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Replacement kit for outer shell, Broselow Product Usage: The AirLife Resuscitation devices are manual resuscitation device…

Vyaire Medical
FDA Devices Moderate May 16, 2018

Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 16, 2018

BECKMAN COULTER iChemVELOCITY, Urine Chemistry System, Catalog Numbers: 800-3530, 800-7167, 800-7719, 800-7720, 800- 7106, 800-3049, 800-3050, 800-…

Beckman Coulter Inc.
FDA Devices Moderate May 16, 2018

POWERPORT ClearVUE Slim Implantable Port with Smooth Septum and Attachable 8F Polyurethane Open-Ended Single-Lumen Venous Catheter Custom Kit, REF CP…

Bard Peripheral Vascular Inc
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, manometer, PEEP valve Product Usage: The AirLife Resuscitation devices are manual …

Vyaire Medical
FDA Devices Moderate May 16, 2018

NICU ECC Pack BEQ-TOP 39202, Custom Tubing Kit, Catalog No. 701067313R01

Datascope Corporation
FDA Devices Moderate May 16, 2018

MicroVue BAP EIA, Model 8012, provides a quantitative measure of bone-specific alkaline phosphatase (BAP) activity in serum.

Diagnostic Hybrids, Inc.
FDA Devices Moderate May 16, 2018

Retractor f/Sciatic Nerve Long; Part number: 03.100.014; UDI: 10886982070630

Synthes (USA) Products LLC
FDA Devices Critical May 16, 2018

Fabius GS Premium, anesthesia machine, catalog no. 8607000 Product Usage: The products are inhalation anesthesia machines for use in operating, i…

Draeger Medical, Inc.
FDA Devices Moderate May 16, 2018

Baxter Sigma Spectrum Infusion Pump with master Drug Library (Version 6) 35700BAX Product Usage: The Baxter Sigma Spectrum Infusion Pump with mas…

Baxter Healthcare Corporation
FDA Devices Moderate May 16, 2018

Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 16, 2018

BO-TOP 20705 SMALL PATIENT 1/4, Catalog No. 701053486

Datascope Corporation
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Infant, with mask, 28inch large bore tubing, pressure-relief valve Product Usage: The AirLife Resuscitation devices are ma…

Vyaire Medical
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, oxygen reservoir bag, manometer, pressure-relief valve, PEEP valve Product Usage: The AirLife Resusc…

Vyaire Medical
FDA Devices Moderate May 16, 2018

AEQUALIS HUMERAL NAIL DRILL BIT, REF 7020140 Product Usage: The Aequalis Humeral Nail system is intended to provide temporary stabilization of v…

Tornier, Inc
FDA Devices Moderate May 16, 2018

Syngo.plaza software Syngo.Plaza is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate…

Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 16, 2018

BEQ-TOP 41201 ECC 3/8 PUMP PAC, Custom Tubing Kit, Catalog No. 701064867

Datascope Corporation
FDA Devices Moderate May 16, 2018

Connecting Tube - Female to Male Luer Lock, HPCT8.8-80-M-FM Product Usage: The connecting tube is intended to be a conduit between a fluid reserv…

Cook Inc.
FDA Devices Low May 16, 2018

Thumper Cardiopulmonary Resuscitator, Model 1007CCV, Catalog No. 15370 Product Usage: The device is used to perform Cardiopulmonary Resuscitation (…

Michigan Instruments, Inc.
FDA Devices Moderate May 16, 2018

Jasper Vektor, Class II Correction Appliance, Part No. 610-533Lused for correcting class 2 malocclusions by applying light forces on the teeth using …

TP Orthodontics, Inc.
FDA Devices Moderate May 16, 2018

BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253

Datascope Corporation
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Pediatric, with mask, 40inch oxygen reservoir tubing, pressure-relief valve, Broselow Product Usage: The AirLife Resuscita…

Vyaire Medical
FDA Devices Moderate May 16, 2018

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP Convenience kit for the insertion of PICCs into the vascular system.

Vygon U.S.A.
FDA Devices Critical May 16, 2018

AirLife Resuscitation, Adult, with mask, oxygen reservoir bag, CO2 detector Product Usage: The AirLife Resuscitation devices are manual resuscita…

Vyaire Medical
FDA Devices Moderate May 16, 2018

BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430

Datascope Corporation
FDA Devices Moderate May 16, 2018

Syngo.Via VB20A model 1049610

Siemens Medical Solutions USA, Inc
FDA Devices Moderate May 16, 2018

Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healthcare Diagnostics, Newark, DE)

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate May 16, 2018

Ondamed Biofeedback Device, Model No. 001-00-0101 The product is a battery powered biofeedback device that is indicated for relaxation training an…

Ondamed 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.