Sep 23, 2026
Z-3190-2026
Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Device recalls
openFDA device enforcement reports, enriched with the device recall endpoint when a product code or CDRH recall id is available.
779 records
Sep 23, 2026
Z-3189-2026
Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000
Datex-Ohmeda, Inc.
- BSZ
- Class II
- Ongoing
Sep 23, 2026
Z-3188-2026
Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cabl…
Boston Scientific Corporation
- FGB
- Class II
- Ongoing
Sep 23, 2026
Z-3187-2026
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3186-2026
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3185-2026
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3184-2026
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3183-2026
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3182-2026
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 100MM
Stryker Sustainability Solutions
- NLM
- Class II
- Ongoing
Sep 23, 2026
Z-3181-2026
Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD…
Medical Action Industries, Inc. 306
- OFM
- Class II
- Ongoing
Sep 23, 2026
Z-3180-2026
EWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC
- FMI
- Class II
- Ongoing
Sep 23, 2026
Z-3179-2026
EWO_02512 (Catalog number 320550) For Investigational Use Only Nano Pro Un-Cannulated Demo Samples Quantity 100
embecta Medical II LLC
- FMI
- Class II
- Ongoing
Sep 23, 2026
Z-3178-2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc.
- OYK
- Class II
- Ongoing
Sep 23, 2026
Z-3177-2026
Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number: HEMO-7, HEMO-10, HEMO-7-EU, HEMO-10-EU Software Ver…
Wilson-Cook Medical Inc.
- QAU
- Class II
- Ongoing
Sep 23, 2026
Z-3176-2026
Happiest Baby, Inc. SNOO Sleep Sack, X-Large Model/Catalog Number: S2101-501 S2101-508-11 S2101-508-3 S2101-508-4 S2101-508-5 S2101-508-6 S2101-508-7 S2101-512…
Happiest Baby, Inc
- QTG
- Class II
- Ongoing
Sep 23, 2026
Z-3175-2026
Happiest Baby, Inc SNOO Sleep Sack, X-Small Model/Catalog Number: S2101-101 S2101-108-6 S2101-133 S2102-112 S2107-101 S2107-110
Happiest Baby, Inc
- QTG
- Class II
- Ongoing
Sep 23, 2026
Z-3174-2026
Brand Name: VERIQA; Product Name: RT MonteCarlo 3D v3; Model/Catalog Number: S070031.520; Software Version: 3.1.18;
PTW FREIBURG
- IYE
- Class II
- Ongoing
Sep 23, 2026
Z-3173-2026
GM Helix Implant, REF: 109.984;
Straumann USA LLC
- DZE
- Class II
- Ongoing
Sep 23, 2026
Z-3172-2026
SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
WELL LEAD MEDICAL CO. LTD
- BTR
- Class II
- Ongoing
Sep 23, 2026
Z-3171-2026
Core Services Hub V8, a set of backend services including Cross Enterprise (XE) and Workflow Core (WFC) services that enables enterprise imaging workflows, All…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3170-2026
Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common conf…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3169-2026
Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3168-2026
Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, edi…
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3167-2026
Enterprise Archive V8, software product for receiving, archiving, and sending electronic medical data, All versions
GE Healthcare
- LLZ
- Class II
- Ongoing
Sep 23, 2026
Z-3166-2026
Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
GE Healthcare
- LLZ
- Class II
- Ongoing