PlainRecalls

Product category · Updated Jun 3, 2026

Medical Devices recalls

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

Total recalls
40,478
Top agency
FDA Devices
Years covered
2000–2026
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Medical Devices accounts for 40,478 recalls — about 40.4% of the federal recall archive, of which 9% of graded records are high-severity.

The FDA, CPSC and NHTSA have published 40,478 medical devices recalls between 2000 and 2026 — roughly 40.4% of the 100,165-record archive. Of the 40,478 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.

  • 40,478 total recalls
  • 40.4% of the archive
  • 9% graded high-severity
  • FDA Devices top agency

Category snapshot

Medical Devices accounts for 40,478 recalls — about 40.4% of the 100,165-record federal archive, with 3,549 graded high-severity, most issued by FDA Devices.

40,478
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 2567 3385 2655 3821 3004 3208 2360 2254 2607 3417 2992 1243

Source: FDA · CPSC · NHTSA As of Jun 3, 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 71 of 810

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ01…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (…

Checkpoint Surgical Inc

FDA Devices Moderate Apr 2, 2025

Baxter Stationary column TruSystem 7500 U, Product Code 1730731

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) GENERAL ENDOSCOPY PACK, Pack Number DYNJ44673G

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PAC…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ACL ARTHROSCOPY PACK, Pack Number DYNJ55316G; 2) ARTERIOGRAM PACK, Pack Number DYNJ64332; 3) ARTHRO PACK-LF…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid MR IMRIS, Product Code 2067886

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter Operating table column TS7500 MOBIUS, Product Code 1704695

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Progressa Bed Surfaces, intended to be used to treat or prevent pulmonary or other complications associated with immobility, Product Codes P7520A19, …

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) L S GYN PACK, Pack Number DYNJ65616C; 2) MAIN CYSTO, Pack Number DYNJ61371A; 3) OB PACK-LF, Pack Number …

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Num…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Conven…

American Contract Systems, Inc.

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid (FC), Product Code 1854085

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) BREAST PACK-LF, Pack Number DYNJ0956628O; 2) BREAST SURGERY FOAKS, Pack Number DYNJ63577C; 3) CHEST BREA…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10

Zimmer, Inc.

FDA Devices Critical Apr 2, 2025

CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended for endoscopic examination/treatment of urinary tract and kidney interior.

Calyxo, Inc.

FDA Devices Moderate Apr 2, 2025

Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPH…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Apr 2, 2025

Baxter Floor mounting column TruSystem 7500, Product Code 1717021

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Baxter Floor mounting column TS 7500 U, Product Code 1730732

Baxter Healthcare Corporation

FDA Devices Moderate Apr 2, 2025

Baxter Mobile column TruSystem 7500, Product Code 1717023

Baxter Healthcare Corporation

CPSC Moderate Mar 27, 2025

APOTHEKE Recalls Pumpkin Ginger 3-Wick Scented Candles Due to Fire, Burn and Laceration Hazards; Sold Exclusively at Crate & Barrel

APOTHEKE, of Brooklyn, New York

FDA Devices Moderate Mar 26, 2025

MAJOR VASCULAR PACK , Model No UTMV78X-01 UTMV78Y UTMV78Y-01 UTMV78X-01 UTMV78Y-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 101294…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Infant, PT00156250 - Mic…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 -…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

LABOR & DELIVERY PACK, Model Nos LLLD19H

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstr…

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS; PACK,BASIC IV,SIRUS,5/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DRAPE,12/CS; PACK,SET UP,NO DR…

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

C-SECTION PACK, Model Nos LLCS44F LLCS44F-01

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV40…

Remel, Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm., 6Fr Introducer, REF 21-…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.

MEDLINE INDUSTRIES, LP - Northfield

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 9.x, Software Version: 9.0.6 and 9.0.8; VERICIS is an integrated cardiovascular information syst…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

DIAGNOSTIC NEURO IR TRAY , Model No WENE21

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

DELIVERY PACK , Model No SGDV22D-01 SGDV22E

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Advance Intubated Adult-Pediatric, PT00156254 …

Oridion Medical 1987 Ltd.

FDA Devices Moderate Mar 26, 2025

VERICIS, Merge Cardio, Model/Catalog Number: Version 10.x, Software Version: 10.0, 10.1.1.1, 10.1.2, 10.2.0, 10.2 P2 , 10.3; The VERICIS is an integr…

Merge Healthcare, Inc.

FDA Devices Moderate Mar 26, 2025

OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I

American Contract Systems Inc

FDA Devices Critical Mar 26, 2025

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.5Fr Introd…

Smiths Medical ASD, Inc.

FDA Devices Moderate Mar 26, 2025

HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

LAPAROSCOPY PACK , Model No SFLA02A SFLA02B

American Contract Systems Inc

FDA Devices Moderate Mar 26, 2025

CYSTO , Model No SACY80R

American Contract Systems 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 Jun 3, 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 Jun 3, 2026.