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 332 of 819

FDA Devices Moderate Jul 22, 2020

OSTEOVATIONEX 5CC, INJECT FORMULA. Product Number: 390-0005, UDI: 813845020023 - Product Usage: Callos is indicated to fill bony voids or gaps of th…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

OSTEOVATION, 5CC, IMPACT FORMULA. Product Number: 390-2105, UDI: 813845020085 - Product Usage: Callos is indicated to fill bony voids or gaps of the…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

OSTEOVATION RMX 10CC. Product Number: 390-6002, UDI: 813845021099 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sy…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XPS

CME America, LLC
FDA Devices Moderate Jul 22, 2020

SKAFFOLD CMF IMPRESS (MP), 10CC. Product Number: CMMP-IM10, UDI: 813845020696 - Product Usage: Callos is indicated to fill bony voids or gaps of the…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset With Female Luer, REF: A120-160XPSN

CME America, LLC
FDA Devices Moderate Jul 22, 2020

MEDTRONIC BONE VOID FILLER, LARGE. Product Number: C07B, UDI: 813845020511 - Product Usage: Callos is indicated to fill bony voids or gaps of the sk…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre…

Neocis Inc.
FDA Devices Moderate Jul 22, 2020

EXACTECH OSSILIX FIL (MX), 10CC. Product Number: 660-02-10, UDI: 813845021013 - - Product Usage: Callos is indicated to fill bony voids or gaps of t…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160X2YB

CME America, LLC
FDA Devices Moderate Jul 22, 2020

ACUMED CALLOS INJECT 5CC. Product Number: 65-0005-S, UDI: 813845020238 - Product Usage: Callos is indicated to fill bony voids or gaps of the skelet…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard BodySet, REF: A120-160SAS

CME America, LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-160XSFK

CME America, LLC
FDA Devices Moderate Jul 22, 2020

EXACTECH OSSILIX FIL (MX), 5CC. Product Number: 660-02-05, UDI: 813845021006 - Product Usage: Callos is indicated to fill bony voids or gaps of the …

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT, CMF IMPACT, 3CC Product Number: C-CMF3CC, UDI: 813845020931 - Product Usage: Callos is indicated to fill bony voids or gaps of the ske…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

CMExpress Microbore Sets, REF: A120-161C

CME America, LLC
FDA Devices Moderate Jul 22, 2020

SKAFFOLD FLOW, 10CC. Product Number: SKMX-FL10, UDI: 813845020900 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sy…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT, CMF IMPACT, 10CC, Product Number: C-CMF10CC, UDI: 813845020955 - Product Usage: Callos is indicated to fill bony voids or gaps of the …

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160CYFRV

CME America, LLC
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT FLOW, 3CC. Product Number: C-FLOW3CC, UDI: 813845020320 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skelet…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard set with Female Luer, REF: A120-003XSN

CME America, LLC
FDA Devices Moderate Jul 22, 2020

SKAFFOLD FLOW (MX) 5CC. Product Number: SKMX-FL05, UDI: 813845020894 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter, REF: A120-160XSFE

CME America, LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter and Manual Priming Valve, REF: A120-112XSFV

CME America, LLC
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT FLOW, CAN, 10CC, Product Number: C-FLOW10CC-CAN, UDI: 813845020375 - Product Usage: Callos is indicated to fill bony voids or gaps of t…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

OSTEOVATION IMPACT 10CC and OSTEOVATION, 10CC, IMPACT FORMULA, Product Number: 390-2110, UDI: 813845020092 - Product Usage: Callos is indicated to f…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended for use on the LIAISON MDX instrument for the qualitative detection of varicella-zoster…

DiaSorin Molecular LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XPSV

CME America, LLC
FDA Devices Moderate Jul 22, 2020

Trinias DAP Meter, a component of the Digital Anglo System Trinias contained within the DAR-9500f - Product Usage: It is intended to be used for inte…

Shimadzu Medical Systems
FDA Devices Moderate Jul 22, 2020

OSTEOVATION RMX 5CC. Product Number: 390-6001, UDI: 813845021082 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

ACUMED CALLOS INJECT 10CC. Product Number: 65-0010-S, UDI: 813845020245 - Product Usage: Callos is indicated to fill bony voids or gaps of the skele…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-161XYBS

CME America, LLC
FDA Devices Moderate Jul 22, 2020

ACUMED CALLOS INJECT 3CC. Product Number: 65-0003-S, UDI: 813845020221 - Product Usage: Callos is indicated to fill bony voids or gaps of the skele…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A100-163XSL

CME America, LLC
FDA Devices Critical Jul 22, 2020

Standard BodySet with Needleless Connectors, REF: A120-125XS

CME America, LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Male Luer Connectors, REF: A100-163XEBF

CME America, LLC
FDA Devices Moderate Jul 22, 2020

SKAFFOLD CMF IMPRESS (MP), 5CC. Product Number: CMMP-IM05, UDI: 813845020689 - Product Usage: Callos is indicated to fill bony voids or gaps of the …

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

SKAFFOLD FLOW, 3CC and SKAFFOLD FLOW (MX) 3CC. Product Number: SKMX-FL03, UDI: 813845020887 - Product Usage: Callos is indicated to fill bony voids …

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

OSTEOVATION, 10CC, INJECT FORMULA. Product Number: 390-2010, UDI: 813845020061 - Product Usage: Callos is indicated to fill bony voids or gaps of th…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT C, 5CC. Product Number: C-C5CC, UDI: 813845021112 - - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous / Mucocutaneous Swabs Product Usage: is intended for use on the LIAISON MDX instrument …

DiaSorin Molecular LLC
FDA Devices Moderate Jul 22, 2020

OSTEOVATIONEX 2CC INJECT FORMULA. Product Number: 390-0002, UDI: 813845020009 - Product Usage: Callos is indicated to fill bony voids or gaps of the…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset with Filter, REF: A100-164XESF

CME America, LLC
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT C, 3CC. Product Number: C-C3CC, UDI: 813845021105 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal syste…

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A100-163XE90S

CME America, LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-003XS2YV

CME America, LLC
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT C, 10CC. Product Number: C-C10CC, UDI: 813845021129 - Product Usage: Callos is indicated to fill bony voids or gaps of the skeletal sys…

Skeletal Kinetics, Llc
FDA Devices Moderate Jul 22, 2020

CRANIOSCULPT FLOW, OUS, 5CC Product Number: C-FLOW5CC-OUS, UDI: 813845020351 - Product Usage: Callos is indicated to fill bony voids or gaps of the …

Skeletal Kinetics, Llc
FDA Devices Critical Jul 22, 2020

BodyGuard Microset w/ 0.2 mic filter and lower y-site with female luer, REF: A120-160XYBF

CME America, LLC
FDA Devices Critical Jul 22, 2020

BodyGuard Microset, REF: A120-112XSFK

CME America, LLC

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.