Product category · Updated Jul 2, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
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
Severity distribution
Graded records only
- High severity 3,538
High severity
3,538 recalls
- Moderate
Moderate
35,780 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,096 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 307
CPSC
307 recalls
- FDA Food 35
FDA Food
35 recalls
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 72 of 808
LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
American Contract Systems Inc
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-…
Smiths Medical ASD, Inc.
VERICIS, Merge Cardio, Model/Catalog Number: Version 12.X, Software Version: 12.0.1, 12.0.2; The VERICIS is an integrated cardiovascular information …
Merge Healthcare, Inc.
Candida ID Antigen, REAG, AG, REF C50110, Vol 1 mL REF ID1001, Immy Fungal Antigens, Positive Controls, & Immunodiffusion (ID) plates for use in t…
Immuno-Mycologics, Inc
smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introd…
Smiths Medical ASD, Inc.
Microstream Instructions for Use and Part Number used with - Product Description, REF: OmniVentLine Set, 012808 - OmniVentLine Set Adult-Pedi…
Oridion Medical 1987 Ltd.
Proxima Drape labeled as UNIVERSAL DAVINCI ROBOTIC P. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 11 mm, Product Code: 880-601/11
Waldemar Link GmbH & Co. KG (Mfg Site)
VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
American Contract Systems Inc
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - …
Oridion Medical 1987 Ltd.
Proxima Drape labeled as HEAD AND NECK OSIS, WILLIS SHOULDER PACK, EXTREMITY PACK-LF, TOTAL HIP PACK-LF, SHOULDER W/POUCH-LF, VEIN PACK. Sterile surg…
MEDLINE INDUSTRIES, LP - Northfield
Helix Elite" Inactivated Standard: Inactivated SARS-CoV-2 Whole Virus (Pellet), Multi-analyte, unassayed quality control material, Catalog Number HE0…
Microbiologics Inc
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
Smiths Medical ASD, Inc.
CYSTO PACK , Model N. HKCY31A
American Contract Systems Inc
Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 11…
ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
BORN ON ARRIVAL KIT , Model No LLBN11B
American Contract Systems Inc
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW1100
Smiths Medical ASD, Inc.
URO ROBOTIC PACK , Model No LVUR44C LVUR44C-03
American Contract Systems Inc
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 13 mm, Product Code: 880-601/13
Waldemar Link GmbH & Co. KG (Mfg Site)
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
Smiths Medical ASD, Inc.
C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
American Contract Systems Inc
Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
Brainlab AG
smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9Fr Introducer, REF 21-4187-24
Smiths Medical ASD, Inc.
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
Smiths Medical ASD, Inc.
AV FISTULA , Model No UTAV77T
American Contract Systems Inc
smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
Smiths Medical ASD, Inc.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Infant Intubated, PT00134354 - Micros…
Oridion Medical 1987 Ltd.
Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Adv. Adult-Pediatric Intubated, PT00134333 - …
Oridion Medical 1987 Ltd.
Proxima Drape labeled as MINOR PACK and LAPAROSCOPY. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
THORACIC PACK , Model No UTTC82Y UTTC82AA-01
American Contract Systems Inc
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Beckman Coulter, Inc.
BD Pyxis: Anesthesia Station ES, REF: 327, MedStation ES, REF: 323, MedStation ES Tower, REF: 352, CII Safe ES, REF: 1116-00, CII Safe ES Deskt…
CareFusion 303, Inc.
Access 2 Immunoassay Analyzer, Catalog Number 81600N
Beckman Coulter, Inc.
Proxima Drape labeled as ENT-PLASTICS PACK. Sterile surgical drape.
MEDLINE INDUSTRIES, LP - Northfield
OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
American Contract Systems Inc
Synapse PACS Software Version 7.4.x; Software Versions: 7.4.000, 7.4.001, 7.4.010, 7.4.100, 7.4.110, 7.4.200.
FUJIFILM Healthcare Americas Corporation
Medline procedure kits labeled as: 1) EYE PACK, Pack Number VAL038BSCLC
MEDLINE INDUSTRIES, LP - Northfield
CV BASIC PUMP PACK , Model No WECV23D
American Contract Systems Inc
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ909098
MEDLINE INDUSTRIES, LP - Northfield
IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit; UPN/Catalog Number: ISO-60;
Angiodynamics, Inc.
Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/…
MEDLINE INDUSTRIES, LP - Northfield
Modular Stem cylindrical, Tilastan¿, press-fit cementless, L= 80 mm, DIA = 12 mm, Product Code: 880-601/12
Waldemar Link GmbH & Co. KG (Mfg Site)
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
B Braun Medical Inc
MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H
American Contract Systems Inc
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
American Contract Systems Inc
NEURO IR TRAY , Model No WENI56J
American Contract Systems Inc
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137.
Beckman Coulter, Inc.
LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
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
- Source: FDA - openFDA Enforcement API (food, drug, and device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls
- Source: NHTSA - National Highway Traffic Safety Administration Recalls (vehicles & equipment)
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.