Product category · Updated Jul 29, 2026
Medical Devices recalls
Medical device recalls including implants, diagnostic equipment, and surgical tools
Medical Devices ranks #1 of 12 among PlainRecalls categories by recall count (40,910 notices, 39.3% of the archive); 9% of graded records are high-severity.
The FDA, CPSC and NHTSA have published 40,910 medical devices recalls between 2000 and 2026 - roughly 39.3% of the 104,158-record archive. Among 12 product categories, that is #1 of 12. Of the 40,910 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.
- 40,910 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 40,910 recalls, about 39.3% of the 104,158-record federal archive, with 3,645 graded high-severity, most issued by FDA Devices.
- 40,910
- total recalls
- #1 of 12
- category rank by events
- 9%
- graded high-severity
- FDA Devices
- top issuing agency
Medical Devices recalls by year
2000–2026
Severity distribution
Graded records only
- High severity 3,645
High severity
3,645 recalls
- Moderate
Moderate
36,211 recalls
- Lower severity 1,054
Lower severity
1,054 recalls
Recalls by issuing agency
- FDA Devices
FDA Devices
39,635 recalls
- FDA Drug 934
FDA Drug
934 recalls
- CPSC 306
CPSC
306 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 250 of 819
TearCare version 1.0 SmartHubs
Sight Sciences, Inc.
RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server. There is no ph…
Roche Diabetes Care, Inc.
PrisMax System, Product Code 955626
Baxter Healthcare Corporation
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Sim Model Number 11061660. Running on servers with syngo.via VB60 software after upg…
Siemens Medical Solutions USA, Inc
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; an…
ROi CPS LLC
NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (…
NeuMoDx Molecular Inc
syngo.via RT Image Suite upgraded to VB60 running on SOMATOM go.Open Pro Model Number 11061670. Running on servers with syngo.via VB60 software aft…
Siemens Medical Solutions USA, Inc
Philips Respironics V680 Ventilator (All Models, including: P/N 1103044 (850011)), *Distributed outside the United States
Respironics California, LLC
Virus Counter Platform with Model Name VC3100
Sartorius Corporation
Artis zee floor MN, Model Number 10094142
Siemens Medical Solutions USA, Inc
Artis Q ceiling, Model Number 10848281
Siemens Medical Solutions USA, Inc
Artis Q zeego, Model Number 10848283
Siemens Medical Solutions USA, Inc
Artis Q.zen floor, Model Number 10848353
Siemens Medical Solutions USA, Inc
Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
Microbiologics Inc
Artis zee biplane, Model Number 10094141
Siemens Medical Solutions USA, Inc
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve DD, Model A-TCSE-DD, Sterile.
Abbott
Philips Respironics V60 Plus Ventilator (All Models, including: 1138747, 1137276)
Respironics California, LLC
Artis zee multi-purpose, Model Number 10094139
Siemens Medical Solutions USA, Inc
Artis zee biplane MN, Model Number 10094143
Siemens Medical Solutions USA, Inc
Matrix Clinical Solution At-Home COVID-19 Test
Matrix Medical Network
Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter, Bi-D, Curve D-F, Model A-TCSE-DF, Sterile.
Abbott
SIEMENS SOMATOM with software syngo CT VA30A_SP4 Models: SOMATOM go.Now 11061610 & 11061618 SOMATOM go.Up 11061620 & 11061628 SOMATOM go.All…
Siemens Medical Solutions USA, Inc
Artis icono floor in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imaging …
Siemens Medical Solutions USA, Inc
Gallant HF Implantable Cardioverter Defibrillator REF# CDHFA500Q
St. Jude Medical, Cardiac Rhythm Management Division
therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)
Qiagen Sciences LLC
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing t…
SIGHT DIAGNOSTICS LTD
GE Healthcare MR Systems, Magnetic Resonance imaging (MRI). SIGNA Premier, SIGNA Architect, SIGNA Pioneer, Discovery MR750w 3.0T, Discovery MR750 …
GE Healthcare, LLC
Artis Q floor, Model Number 10848280
Siemens Medical Solutions USA, Inc
Gallant DR Implantable Cardioverter Defibrillator REF # CDDRA500Q
St. Jude Medical, Cardiac Rhythm Management Division
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Medtronic Inc
Philips Respironics V60 Ventilator (All Models, including: 1053613, 1053614, 1053615, 1053616, 1053617, 1053618, 1076709, 1076716, 1076717, 1137292, …
Respironics California, LLC
ORAcollect RNA: ORE-100
DNA Genotek Inc.
Artis icono biplane- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use single and biplane diagnostic imagi…
Siemens Medical Solutions USA, Inc
ORAcollect Dx, Catalog Number/SKU: OCD-100, OCD-100A. Material numbers: OCD-100, OCD-100.008, OCD-100.012, OCD-100.014+ACP078, OCD-100.014+ACP078,…
DNA Genotek Inc.
4.0mm x 10mm Cannulated Screw, Short Thread; Part number 3005-40010
Acumed LLC
Inactivated macrolide-resistant Mycoplasma genitalium
Microbiologics Inc
Artis zee ceiling, Model Number 10094137
Siemens Medical Solutions USA, Inc
Beckman Coulter IRISpec CA/CB/CC control, Catalog #800-7211, containing 3 x 100 mL bottles each of CA Control, CB Control, and CC Control.
Beckman Coulter, Inc.
Artis Q.zen biplane, Model Number 10848355
Siemens Medical Solutions USA, Inc
Artis Q biplane, Model Number 10848282
Siemens Medical Solutions USA, Inc
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and in…
Siemens Medical Solutions USA, Inc
therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)
Qiagen Sciences LLC
Artis Q.zen ceiling, Model Number 10848354
Siemens Medical Solutions USA, Inc
Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked
Acon Biotech (Hangzhou) Co., Ltd.
4.0mm x 12mm Cannulated Screw, Short Thread; Part number 3005-40012
Acumed LLC
HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8
Huntleigh Healthcare Ltd.
Cardiovascular Procedure Kit catalog # 76645 & 73806
Terumo Cardiovascular Systems Corp
Artis zee floor, Model Number 10094135
Siemens Medical Solutions USA, Inc
Merlin 2 PCS MER3700 programmer Model MER3400 software
St. Jude Medical, Cardiac Rhythm Management Division
Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.
Baxter Healthcare Corporation
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 29, 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 29, 2026.