PlainRecalls

Product category · Updated Aug 19, 2026

Medical Devices recalls

Medical device recalls including implants, diagnostic equipment, and surgical tools

Total recalls
41,070
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 (41,070 notices, 39.3% of the archive); 9% of graded records are high-severity.

The FDA, CPSC, USDA FSIS and NHTSA have published 41,070 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,423-record archive. Among 12 product categories, that is #1 of 12. Of the 41,070 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.

  • 41,070 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 41,070 recalls, about 39.3% of the 104,423-record federal archive, with 3,653 graded high-severity, most issued by FDA Devices.

41,070
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

41,070 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 · USDA FSIS · NHTSA federal recall filings · 2026-09-20

Do more recalls mean more Class I danger?

Medical Devices sits at the 100th percentile of category volume (41,070 recalls) and the 14th percentile of Class I rate (9% of agency-classified notices) among 7 categories with enough classified rows to measure, those two ranks are not interchangeable.

Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-20. 2×2 strategic matrix plotting 7 entities by Total recalls (count) (X) and Class I share of classified (%) (Y), with a crosshair dividing the plot into four quadrants. Large · Class I–heavySmaller · Class I–heavyLarge · fewer Class ISmaller · fewer Class I 010,00020,00030,00040,00050,000 0%20%40%60%80% Total recalls (count) Class I share of classified (%) Category volume vs Class I rate Signature insight Medical DevicesFoodDrugs & MedicationsChildren & Baby ProductsDietary SupplementsMeat & PoultryCosmetics & Personal Care
Each point is a product category plotted by total recalls (x) and Class I share of agency-classified notices (y). Crosshairs mark the within-sample medians (4,017 recalls · 15.7% Class I). Rate uses only rows with an agency Class I/II/III label, CPSC/NHTSA blanks stay out of the denominator. Medical Devices is the clearest volume-without-Class-I-density example in this release. Source: FDA, CPSC, USDA FSIS & NHTSA public recall data as of 2026-09-20.
Read the chart, every category as text

Percentiles are within this release's classified-enough category sample. Class I % uses only agency-classified notices.

CategoryRecallsVol %ileClassifiedClass IClass I %Rate %ile
Medical Devices41,07010040,7633,6539%14
Food25,5138625,22211,67646.3%86
Drugs & Medications14,4737114,4171,50810.5%29
Children & Baby Products4,017572,48335214.2%43
Dietary Supplements2,018431,99346623.4%71
Meat & Poultry1,672291,6721,14568.5%100
Cosmetics & Personal Care1,388141,28920315.7%57

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 1947

Source: FDA · CPSC · USDA FSIS · NHTSA As of Aug 19, 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 25 of 822

FDA Devices Moderate Apr 8, 2026

Artoura Breast Tissue Expanders Reference Numbers: TEXP110RH TEXP120RH TEXP120RUH TEXP130RH TEXP135RH TEXP140RH TEXP150RH Textured, High & Ultra High Profile, Integral Injection Dome, 300cc, 375cc, 535cc, 475cc, 500cc, 600cc, 750cc,

Mentor Texas, LP.
FDA Devices Moderate Apr 8, 2026

ALLURA Xper FD20 Biplane; System Code: (1) 722008, (2)722013;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754)

Medtronic MiniMed, Inc.
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Leg Wraps.

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and

Intuitive Surgical, Inc.
FDA Devices Moderate Apr 8, 2026

Allura Xper FD20/15 OR Table; System Code: 722059;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159

Civco Medical Instruments Co. Inc.
FDA Devices Moderate Apr 8, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-113TH, SCPX-123TH, SCPX-140TH, SCPX-146TH Smooth Tall Height Tissue Expander, 350cc, 450cc, 650cc, 750cc

Mentor Texas, LP.
FDA Devices Moderate Apr 8, 2026

MiniMed 620G Insulin Pump (MMT-1750)

Medtronic MiniMed, Inc.
FDA Devices Moderate Apr 8, 2026

2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.

Synthes (USA) Products LLC
FDA Devices Moderate Apr 8, 2026

BD Kiestra" ReadA; Catalog No.: 446948.

BD KIESTRA LAB AUTOMATION
FDA Devices Moderate Apr 8, 2026

Azurion 3 M12; System Code: (1)722063, (2)722221, (3)722229;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151

Civco Medical Instruments Co. Inc.
FDA Devices Moderate Apr 8, 2026

Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

Airway Exam Kit, DYKE1796

Medline Industries, LP
FDA Devices Moderate Apr 8, 2026

Paradigm Insulin Pump (MMT-712, MMT-715)

Medtronic MiniMed, Inc.
FDA Devices Moderate Apr 8, 2026

eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157

Civco Medical Instruments Co. Inc.
FDA Devices Moderate Apr 8, 2026

Azurion 5 M12; System Code: (1)722227, (2)722231;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

Oxoid Australia Pty Limited
FDA Devices Moderate Apr 8, 2026

eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150

Civco Medical Instruments Co. Inc.
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Half Aprons.

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Vest

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

MiniMed 740G Insulin Pump (MMT-1811, MMT-1812, MMT-1861, MMT-1862)

Medtronic MiniMed, Inc.
FDA Devices Critical Apr 8, 2026

Automated Impella Controller (AIC), labeled as the following with corresponding Product Codes: 1. Impella Controller, Packaged, CA; Product Code: 0042-0000-CA. 2. Impella Controller, Packaged, EU; Product Code: 0042-0000-EU. 3. Impella Controller, Packaged, UK; Product Code: 0042-0000-UK. 4. Impella Controller, Packaged, US; Product Code: 0042-0000-US. 5. Impella Optical Controller, Packaged, EU; Product Code: 0042-0010-EU. 6. Impella Optical Controller, Packaged, UK; Prod

Abiomed, Inc.
FDA Devices Moderate Apr 8, 2026

ALLURA Xper FD20 Biplane OR Table; System Code: (1) 722020, (2)722025;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

Brand Name: Olympus SOLTIVE Premium SuperPulsed Laser System Product Name: SOLTIVE Premium Laser System TFL-PLS Model/Catalog Number: TFL-PLS containing TFL-CPLU Product Description: An electricity powered device assembly which emits a high-power laser beam to vaporize/ablate soft tissue with moderate hemostasis, little charring, and a thin zone of necrosis. Component: No

Olympus Corporation of the Americas
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Demi Half Aprons.

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

ALLURA Xper FD10F; System Code: 722002;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;

Siemens Healthcare Diagnostics, Inc.
FDA Devices Moderate Apr 8, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: 354-9113, 3549313, 354-9314 SILTEX Low Height Tissue Expander Style (9100, 450cc), (9300, 450cc), (9300, 550cc)

Mentor Texas, LP.
FDA Devices Moderate Apr 8, 2026

Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723)

Medtronic MiniMed, Inc.
FDA Devices Moderate Apr 8, 2026

Medline Kits containing ENFIT G-TUBE CONNECTOR 1. SKU DYKM2720 G/J TUBE CARE KIT 2. SKU ENFITDISCKIT ENFIT DISCHARGE KIT

Medline Industries, LP
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Kilt Blockers.

Burlington Medical, LLC
FDA Devices Critical Apr 8, 2026

Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes. 1. Purge Cassette, 5 Pack; Product Code: 0043-0003. 2. Impella RP US Pump Set; Product Code: 004334. 3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001. 4. Impella 2.5 Set; Product C

Abiomed, Inc.
FDA Devices Moderate Apr 8, 2026

Medline kits containing Olympus biopsy valves: 1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G 2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J 3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A 4. RIGID KIT, DYNDA2138A

Medline Industries, LP
FDA Devices Moderate Apr 8, 2026

CPX 4 US Breast Tissue Expanders with Suture Tabs Reference Numbers: SCPX-157LH Smooth Low Height Tissue Expander, 650cc

Mentor Texas, LP.
FDA Devices Moderate Apr 8, 2026

Allura Xper FD20/10; System Code: 722029;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

Artoura Breast Tissue Expanders Reference Numbers: SDC-100H SDC-110H SDC-120H SDC-130H SDC-135H SDC-140H SDC-150H SDC-155H Smooth High Profile Tissue Expander, 225cc, 300cc, 375cc, 475cc, 500cc, 600cc, 750cc, 850cc

Mentor Texas, LP.
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Protective Sleeves.

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and

Intuitive Surgical, Inc.
FDA Devices Moderate Apr 8, 2026

ENFIT G-TUBE CONNECTOR, MEDLINE Item No. ENFIT1010GC

Medline Industries, LP
FDA Devices Moderate Apr 8, 2026

ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156

Civco Medical Instruments Co. Inc.
FDA Devices Moderate Apr 8, 2026

Brand Name: Paradise¿ Ultrasound Renal Denervation System Product Name: Paradise ¿ Catheter Model/Catalog Number: PRDS-068-02 Product Description: Common name: Ablation catheter renal denervation

ReCor Medical Inc.
FDA Devices Moderate Apr 8, 2026

Medline kits containing Olympus biopsy valves: 1. BRONCH PROCEDURE KIT, DYKE2091 2. BRONCHSCOPY, DYNJ900898G DYNJ901922I 3. BRONCHSCOPY PACK, DYNJ38313B 4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I 5. KIT, WR THORACIC, DYNJ911252 6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B 7. LEX THORACIC, DYNJ902016K DYNJ902016L 8. ORGAN PROCUREMENT, DYNJ908686 9. PULMONARY PACK, DYKE1859 10. THORACIC, DYNJ901666L 11. THORACIC ROBOTICS, DYNJ908777A 12. THORACOTO

Medline Industries, LP
FDA Devices Moderate Apr 8, 2026

Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011.

Ultradent Products, Inc.
FDA Devices Moderate Apr 8, 2026

MiniMed 530G Insulin Pump (MMT-551, MMT-751)

Medtronic MiniMed, Inc.
FDA Devices Moderate Apr 8, 2026

Burlington Medical, Frontal Aprons

Burlington Medical, LLC
FDA Devices Moderate Apr 8, 2026

Azurion 3 M15; System Code: (1)722064, (2)722222, (3)722230, (4)722280 (OUS Only);

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA Devices Moderate Apr 8, 2026

MiniMed 780G Insulin Pump (MMT-1884, MMT-1885, MMT-1886, MMT-1894, MMT-1895, MMT-1896)

Medtronic MiniMed, 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

25,513 recalls →

Drugs & Medications

14,473 recalls →

Vehicles

8,938 recalls →

Children & Baby Products

4,017 recalls →

Household Products

3,574 recalls →

Dietary Supplements

2,018 recalls →

Data sources

Category data as of Aug 19, 2026.

Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS 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 Aug 19, 2026.