PlainRecalls

Product category · Updated Jul 2, 2026

Medical Devices recalls

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

Total recalls
40,372
Top agency
FDA Devices
Years covered
2000–2026
Check a product → All categories

Medical Devices accounts for 40,372 recalls, about 39.7% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,372 medical devices recalls between 2000 and 2026 - roughly 39.7% of the 101,704-record archive. Of the 40,372 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.

  • 40,372 total recalls
  • 39.7% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,372 recalls, about 39.7% of the 101,704-record federal archive, with 3,538 graded high-severity, most issued by FDA Devices.

40,372
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 1248

Source: FDA · CPSC · NHTSA As of Jul 2, 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 96 of 808

FDA Devices Moderate Oct 30, 2024

smiths medical portex, Y' PIECE 15MM, REF 100/276/000

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK, REF DYNJ19492L; 2) PHACO PACK, REF DYNJ22354L; 3) EYE PACK, REF DYNJ24…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kit, labeled as: a) PAIN PROCEDURE PACK, REF DYNJ80370A; b) DR HEFZY BLOCK TRAY, REF DYNJRA1854A

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

smiths medical portex, Thermovent 1200, 15mm/22mm: a) REF 100/582/000; b) REF 100/582/000JP; c) REF 100/582/000JS

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

Medline DIALYSIS PACK, REF DYNJ36932A; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Centurion EP LAB INSTRUMENT KIT, REF MNS10480; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and bkActive 2300, model #2300-66, ultrasound system with battery option.

B-K Medical A/S

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9547

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

Medline CENTRAL CATHETER INSERTION TRA, REF CVI680C; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Oct 30, 2024

Aespire 7100, 7100 (Variant), and Aespire 7100 S/5 Protiva configurations. These anesthesia gas machines are intended to provide general inhalation a…

Datex-Ohmeda, Inc.

FDA Devices Moderate Oct 30, 2024

Baxter Operating Table TruSystem 7000 V, Product code REF 1841050

Baxter Healthcare Corporation

FDA Devices Moderate Oct 30, 2024

ENT RES 100 ML Non-Sterile W CLAMP, TUBING FLAG, & FEMALE LUER, Product Code 68-2230-28

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Soltive Premium SuperPulsed Laser - Intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, …

Olympus Corporation of the Americas

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 34IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9545

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

Baxter Operating Table TruSystem 7000, Product code REF 1841046

Baxter Healthcare Corporation

FDA Devices Moderate Oct 30, 2024

Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

medex TranStar Patient Mount Monitoring Kit 10/EA, Product Code REF MX9501T

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

medex TranStar MONITORING SET W/SAMPLING PORT 10/EA, Product Code REF MXG300260

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP20 STERILIZABLE INTERNAL DEFIBRILLATION PADDLES REF LP15 Defibrillation is indicated for the t…

Physio-Control, Inc.

FDA Devices Moderate Oct 30, 2024

medex TranStar KIDS KIT 10IN. CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA, Product Code REF MX9548

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

medex TranStar DPT w/Two Stopcocks 10/EA, Product Code REF MX950X2SC

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

Medtronic Percept RC Implantable Neurostimulators (INS), Model B35300.

Medtronic Neuromodulation

FDA Devices Moderate Oct 30, 2024

Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049

Baxter Healthcare Corporation

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK, REF DYNJ44114; b) DRAPE PACK, REF DYNJ82663B

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

medex TranStar 84in (213cm) Single Monitoring Kit 10/EA, Product Code REF MX9505T

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

AD-TECH Spencer Probe Depth Electrode, REF SD04R-AP58X-000 4-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation

FDA Devices Moderate Oct 30, 2024

medex TranStar 60in (152cm) Single Monitoring Kit 10/EA, Product Code REF MX9504T

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

(1) Centurion Sterile CirClamp, Reorder #200CR; (2) Centurion CirClamp with 1.1cm Bell and Insert, Reorder #210CR, Sterile; (3) Centurion CirClamp …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA, Product Code REF MXG300243R1

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 1604786; b) REF 1604788; c) REF 1723633

Baxter Healthcare Corporation

FDA Devices Moderate Oct 30, 2024

CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF, REF DYNJ46730; b) HYSTEROSCOPY PACK, REF DYNJ49…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF, REF DYNJ0213264O; 2) VAG DELIVERY HLTH ALLIA PK-LF, REF DYNJ03754…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS, REF CDS983525D; 2) CYSTO CDS, REF CDS983525D; 3) CYSTO PACK-LF, RE…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Oct 30, 2024

CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048

Baxter Healthcare Corporation

FDA Devices Moderate Oct 30, 2024

CADD Medication Cassette Reservoir, 50mL, FS, Product Code 21-7301-24

Smiths Medical ASD Inc.

FDA Devices Moderate Oct 30, 2024

medex TranStar Single ICP Set 1/EA, Product Code REF MX20897

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

medex TranStar Single OR Set 1/EA, Product Code REF MX20846R2

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

medex TranStar 72in (183cm) Double Monitoring Kit 10/EA, Product Code REF MX9502T

Smiths Medical ASD, Inc.

FDA Devices Moderate Oct 30, 2024

AD-TECH Spencer Probe Depth Electrode, REF SD06R-AP58X-000 6-Contact 1.12mm (A style) Depth Electrode

Ad-Tech Medical Instrument Corporation

FDA Devices Critical Oct 30, 2024

Avance. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only …

Datex-Ohmeda, Inc.

FDA Devices Moderate Oct 30, 2024

Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Oct 30, 2024

Amingo. OUS only.

Datex-Ohmeda, Inc.

FDA Devices Moderate Oct 30, 2024

Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF, REF CDS982091I; 2) TONSIL CDS, REF CDS984492B; 3) RV T&A PACK-LF,…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Oct 30, 2024

Aespire 7900. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used…

Datex-Ohmeda, 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.

Data sources

Category data as of Jul 2, 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 2, 2026.