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 230 of 819
N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Number (SMN): 10446297
SIEMENS HEALTHCARE DIAGNOSTICS INC
N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Material Number (SMN): 10446299
SIEMENS HEALTHCARE DIAGNOSTICS INC
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
TELEFLEX LLC
Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR, MitraClip G4 Clip Delivery System NT US/CDS0701-NT, MitraClip G4 Clip Delivery Sys…
Abbott Vascular
CENTURION SnagFree Chest Tube insertion Tray, Reorder CHT545
MEDLINE INDUSTRIES, LP - Northfield
Medicina Reusable Oral syringe 5ml Code: OTH05
Medicina Uk Ltd
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter…
TELEFLEX LLC
Medicina Oral Tip Syringe 1ml Code: OT01
Medicina Uk Ltd
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing syste…
TELEFLEX LLC
Medicina Reusable Oral syringe 2.5ml Code: OTH25
Medicina Uk Ltd
SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
Synthes (USA) Products LLC
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT) in laboratory se…
Roche Molecular Systems, Inc.
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
TELEFLEX LLC
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
BALT USA, LLC
DePuy Synthes Hammertoe Continuous Compression Implants, Product No. 46.239.001
Synthes (USA) Products LLC
Medicina Reusable Oral syringe 1ml Code: OTH01
Medicina Uk Ltd
Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
Siemens Healthcare Diagnostics, Inc.
CARESITE SMALLBORE EXT SET T-PORT 5 IN., Product Code 470114, 100 units per carton. The A6 Access Device is a valve intended for the aspiration, inj…
B. Braun Medical, Inc.
SPEEDSHIFT20x20x20 Offset 10mm Implant Drill Kit, Product No. SE-2020-10. Used with DePuy Synthes SPEEDSHIFT Continuous Compression Staple Implants …
Synthes (USA) Products LLC
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Intersurgical Inc
Product/Part: MitraClip NTR Clip Delivery System US/CDS0601-NTR, MitraClip NTR Clip Delivery System CE/CDS0602-NTR, MitraClip XTR Clip Delivery Sys…
Abbott Vascular
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
B. Braun Medical, Inc.
Product/Part: MitraClip G4 CDS NT REPAIR-MR Clinical/CDS0704-NT, MitraClip G4 CDS NTW REPAIR-MR Clinical/CDS0704-NTW, MitraClip G4 CDS XT REPAIR-MR…
Abbott Vascular
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
TELEFLEX LLC
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing…
Becton Dickinson & Company
Extension Set, EXT SET W/CARESITE, 6IN., Product Code 470169, 50 units per carton. A6 Access Device is a valve intended for the aspiration, injection…
B. Braun Medical, Inc.
SPEED 15X12X12mm Continuous Compression Implant, Product No. SE-1512
Synthes (USA) Products LLC
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-u…
TELEFLEX LLC
Hobbs Medical Polypectomy Snare Catalog Number: 4575-OLY
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
Hobbs Medical, Inc.
Hobbs Transbronchial Aspiration Needle Catalog Number: 4621
Hobbs Medical, Inc.
Hobbs Posi-Stop Injection Needle Catalog Number: 4722
Hobbs Medical, Inc.
Hobbs Medical Grasping Forceps Catalog Number:5004
Hobbs Medical, Inc.
Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
Hobbs Medical, Inc.
Hobbs Biliary Pigtail Stent Kits (contains 3412) Catalog Number: 6027
Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4204
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6533
Hobbs Medical, Inc.
Prismaflex HF20 Set (product code 109841). For use in providing continuous fluid management and renal replacement therapies.
Baxter Healthcare Corporation
Hobbs Helical Retrieval Basket Catalog Number: 4822
Hobbs Medical, Inc.
Hobbs Medical Cytology Brush Catalog Number: 4206
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4832
Hobbs Medical, Inc.
Clip COVID Rapid Antigen Test Kit (25-pack), Catalog Number: MDL002
LUMINOSTICS, INC dba CLIP HEALTH
Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
Hobbs Medical, Inc.
Freeman Pancreatic Flexi-Stent Catalog Number: 6584
Hobbs Medical, Inc.
Hobbs Helical Retrieval Basket Catalog Number: 4806
Hobbs Medical, Inc.
Berkeley VC-10 Vacuum Curettage System, Model No. VC-10. For transcervical aspiration of the uterine cavity.
Olympus Corporation of the Americas
Hobbs Posi-Stop Injection Needle Catalog Number: 4718
Hobbs Medical, Inc.
Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191
Hobbs Medical, 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 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.