- [Home](/) › - [FDAPulse](/v/fdapulse) › - [Hubs](/hub/fdapulse) › - Class I device recalls # Recent FDA Class I device recalls **19 recent FDA Class I device recalls are listed from U.S. FDA openFDA, dated 2026-09-30 to 2026-10-28; the most frequent is Ventec Life Systems, Inc. with 12. Data last updated 2026-11-03; each record links to its official source and a full report.** Data as of 2026-11-03 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation Download all 19 recent FDA Class I device recalls (CSV) — $4.99 → Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe [Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?record_type=Class%20I) 19 records from U.S. FDA openFDA, dated 2026-09-30 to 2026-10-28. Most frequent: Ventec Life Systems, Inc. (12). Each record links to a full report and the official source. Last updated 2026-11-03. Source: U.S. FDA openFDA. **Search, filter and export FDAPulse records** [Run instant live search with these filters](/v/fdapulse?record_type=Class%20I&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?record_type=Class%20I) Unlock the full CSV for these filters — $4.99 → ✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days ## Get new FDAPulse records by email (free, weekly) We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email. Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe. [See this week's digest](/digest/fdapulse) Records 19 Most frequent - Ventec Life Systems, Inc. (12) - Instrumentation Laboratory (2) - Medline Industries, LP (2) - Philips Ultrasound, LLC (1) - Draeger, Inc. (1) ## How do I get new recent FDA Class I device recalls by email? Search, filter and export these records, or get alerts when new ones appear. [Search and filter](/v/fdapulse?record_type=Class%20I) [Watch this exact filter](/v/fdapulse?record_type=Class%20I#more-ways) [See alert plans](/v/fdapulse#pricing) ## What are the top recent FDA Class I device recalls right now? | Record | Specialty | Type | Date | |---|---|---|---| | Class I recall Z-0127-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0132-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0131-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0128-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0126-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0123-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0125-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0152-2027: Philips Ultrasound, LLC | Other | Class I | 2026-10-28 | | Class I recall Z-0130-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0129-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0133-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0124-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0122-2027: Ventec Life Systems, Inc. | Other | Class I | 2026-10-28 | | Class I recall Z-0002-2027: Instrumentation Laboratory | Other | Class I | 2026-10-21 | | Class I recall Z-0001-2027: Instrumentation Laboratory | Other | Class I | 2026-10-21 | | Class I recall Z-3228-2026: Medline Industries, LP | Included in the full CSV with every column 🔒 Unlock all 19 records → | | Class I recall Z-3227-2026: Medline Industries, LP | Included in the full CSV with every column 🔒 Unlock all 19 records → | | Class I recall Z-3252-2026: Draeger, Inc. | Included in the full CSV with every column 🔒 Unlock all 19 records → | Browse 4 more matching record reports - [Class I recall Z-3228-2026: Medline Industries, LP](/report/fdapulse/class-i-recall-z-3228-2026-il--z-3228-2026) - [Class I recall Z-3227-2026: Medline Industries, LP](/report/fdapulse/class-i-recall-z-3227-2026-il--z-3227-2026) - [Class I recall Z-3252-2026: Draeger, Inc.](/report/fdapulse/class-i-recall-z-3252-2026-pa--z-3252-2026) - [Class I recall Z-3140-2026: CooperSurgical, Inc.](/report/fdapulse/class-i-recall-z-3140-2026-ct--z-3140-2026) [Browse all FDAPulse record reports](/hub/fdapulse/records) ## Which related categories and locations should I check? ### Browse by record type [510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls) ### Browse by specialty [Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic) ### Browse by record type by specialty [Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances) ## Frequently asked questions ### How many recent FDA Class I device recalls are listed? 19 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-28. ### Can I get alerts for Class I device recalls? Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page. Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml) ## Often used together - [NPIPulse](/v/npipulse) - [EPAPulse](/v/epapulse) - [Municipal Public Works Prime Contract Operating Permit Renewal Pulse](/v/pubworksregrenewpulse) - [TrialRecruitmentPageAudit](/trialrecruitmentpageaudit) - [SubdomainShadowPulse](/subdomainshadowpulse) - [MigrationSignalRadar](/migrationsignalradar) Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.