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 65 of 808
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indica…
Galt Medical Corporation
Bio 1 Granules for Filling ¿ 1 mm (2 cm¿), REF:P822692243, Material: BIOSORB (BTCP 95% minimum purity)
SCIENCE & BIO MATERIALS
Blueprint Software, BPUE001. Intended for use by surgeons as a pre surgical planner for shoulder replacement.
Tornier S.A.S.
Intraocular Lens. enVista Envy IOL, All models starting with EN; enVista Envy Toric IOL, All models starting with ETN.
Bausch & Lomb Surgical, Inc.
Washer Disinfector Aquadis 56; Model Number: 56A
Getinge Disinfection Ab
Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to …
Galt Medical Corporation
Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Galt Medical Corporation
CODMAN Disposable Perforator, 14mm. Cranial perforator.
Integra LifeSciences Corp. (NeuroSciences)
Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553…
Galt Medical Corporation
Intraocular lens. enVista Monofocal IOL, All models starting with EE; enVista Aspire IOL, All models starting with EA; enVista Monofocal Toric IOL,…
Bausch & Lomb Surgical, Inc.
Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Ambu Inc.
GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage pr…
Galt Medical Corporation
Legend Brands Recalls Bliss Hair Dryers Due to Risk of Serious Injury or Death from Electrocution and Shock Hazards; Sold Exclusively at Burlington S…
GE Healthcare CARESTATION 620 A2, Model/REF Number 1012-9620-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A1, Model/REF Number 1012-9655-000. Anesthesia system.
GE Medical Systems China Co., Ltd.
3.0 Liter Disposable Set (4 sets/case). Model Number: 903-00032. The P/N 903-00032 consists of 4 Large Volume Reservoirs (P/N 903-00018) and 4 …
Belmont Instrument LLC
myQA iON; Article Number: MQ10-000;
IBA Dosimetry GmbH
Posterior Femoral Augment; Item Numbers: (1) 880-310/11 (Sz. 0 - cemented sm), (2) 880-310/21 (Sz. 0 - cemented lg), (3) 880-311/11 (Sz. 1-2 - cement…
Waldemar Link GmbH & Co. KG (Mfg Site)
Tibial Augment; Item Numbers: (1) 880-331/11 (Sz. 1-2 - cemented x-sm), (2) 880-331/12 (Sz. 1-2 - cemented sm), (3) 880-331/13 (Sz. 1-2 - cemented md…
Waldemar Link GmbH & Co. KG (Mfg Site)
Semi-Automated External Defibrillators; Models: DDU-100 and DDU-100E. Item numbers: DCF-E110SG-DE/1 (German language), DCF-E110SG-FR/1 (French langua…
Defibtech, LLC
GE Healthcare CARESTATION 750 A2, Model/REF Number 1012-9750-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
IceSeed 1.5 CX S NEEDLE OUS, Cryoablation Needle, REF H7493967334100. The needles are intended to convert high-pressure gas to either a very cold Fr…
Boston Scientific Corporation
DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4…
Beckman Coulter Inc.
Medline procedure kits, labeled as: T AND A PACK -LF, REF DYNJ85792
MEDLINE INDUSTRIES, LP - Northfield
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF D…
MEDLINE INDUSTRIES, LP - Northfield
Medline Sterile 0.9% Normal Saline, USP, 100mL, REF RDI30296
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Carestation 650 SE, Model/REF Number 1012-9650-012. Anesthesia system.
GE Medical Systems China Co., Ltd.
Medline Sterile Water, USP, 100mL, REF RDI30295
MEDLINE INDUSTRIES, LP - Northfield
IceSeed 1.5 CX NEEDLE OUS, Cryoablation Needle, REF H7493967534170. The needles are intended to convert high-pressure gas to either a very cold Free…
Boston Scientific Corporation
Medline procedure kits, labeled as: REDDY JOINT BATH, REF MMJB001A
MEDLINE INDUSTRIES, LP - Northfield
GE Healthcare Carestation 620 A1, Model/REF Number 1012-9620-200. Anesthesia system.
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A2, Model/REF Number 1012-9650-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual …
Defibtech, LLC
GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012. Anesthesia system.
GE Medical Systems China Co., Ltd.
Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description:…
Spectrum Medical Ltd.
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 10736515; epoc Software Version & Sensor Configura…
Siemens Healthcare Diagnostics Inc
Brand Name: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro SuperPulsed Laser System Model/Catalog Numbers: TFL-SLS, TFL-PLS Product D…
Olympus Corporation of the Americas
IceSeed 1.5 CX S NEEDLE US, Cryoablation Needle, REF H7493967233100. The needles are intended to convert high-pressure gas to either a very cold Fre…
Boston Scientific Corporation
Hyperthermia Pump Procedure Kit. Model Number: 902-00045. Sterile, single-use, disposable set used with the Hyperthermia Pump. The Hyperthermia…
Belmont Instrument LLC
Enhanced Verify Evaluation Handset (CFN HH90130FA)
Medtronic Neuromodulation
Automated External Defibrillators, Model DDU-2450. Item number: DCF-E2460DE (German language)
Defibtech, LLC
Distal Femoral Augment; Item Numbers: (1) 880-300/11 (Sz. 0 - cemented sm), (2) 880-300/21 (Sz. 0 - cemented lg), (3) 880-301/11 (Sz. 1-2 - cemented …
Waldemar Link GmbH & Co. KG (Mfg Site)
GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002. Anesthesia system.
GE Medical Systems China Co., Ltd.
GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000. Anesthesia system.
GE Medical Systems China Co., Ltd.
GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200. Anesthesia system.
GE Medical Systems China Co., Ltd.
Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
Siemens Healthcare Diagnostics Inc
GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000. Anesthesia system.
GE Medical Systems China Co., Ltd.
Automated External Defibrillators, Model DDU-2200, IItem numbers: DCF-E2210-D3/1¿(German/English dual language), DCF-E2210-F3/1¿(French/English dual …
Defibtech, LLC
Medline procedure kits, labeled as: OL OCULAR, REF DYNJ906183K
MEDLINE INDUSTRIES, LP - Northfield
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.