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FDA Device Recalls: Enforcement Actions

Rebuilt weeklyCurrent to 2026-08-12
Ledger Distinct recalling firms, trailing year 445Recalls terminated, trailing year 0Recalls still open, trailing year 3209

Live state of FDA medical-device recall enforcement: firms, root causes, and the pace of recalls opened against recalls closed. (Drug and food recalls are not in this feed; recall-severity class is not published here — see section dek.)

58,953
recalls, live count
Added, trailing 7 d3
Added, trailing 30 d190
Most recent event2026-08-12
Update cadenceRebuilt weekly
Freshness Fresh · 7d

Weekly volume

Trailing 26 weeks
10902026-02-152026-05-172026-08-09

Recalling Firms by Volume

Firms with the most recall events initiated, trailing 365 days.

1Medline Industries, LP477
2Olympus Corporation of the Americas136
3B Braun Medical Inc136
4PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.96
5GET TESTED INTERNATIONAL AB92
6Boston Scientific Corporation74
7ICU Medical, Inc.52
8ARROW INTERNATIONAL, LLC47

Root Cause Mix

Recall events by stated root cause, trailing 365 days.

Under Investigation by firm718
Process control506
Nonconforming Material/Component289
Device Design278
No Marketing Application186
Software design117
Process change control109
Component design/selection56

Recalls Initiated versus Terminated

Monthly count of recalls initiated against recalls closed out, trailing 12 months.

2025-08-01
98
2025-09-01
346
2025-10-01
316
2025-11-01
257
2025-12-01
237
2026-01-01
261
2026-02-01
166
2026-03-01
269
2026-04-01
271
2026-05-01
195
2026-06-01
175
2026-07-01
21

Device Risk Classification of Recalled Products

Premarket risk classification of recalled products, trailing 365 days. (This is the product's regulatory device class, not a recall-severity rating.)

LabelCount
Class II2,157
Class I427
Class III141
Unclassified / other61

Latest Recalls

The ten most recently posted recall events.

ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System.
Bioporto Diagnostics A/S — recall Z-2937-2026
ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000
Erbe USA Inc — recall Z-2938-2026
BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 PCR-based mu
BioFire Diagnostics, LLC — recall Z-2936-2026
Endo-Model, Replacement Set, Tibial Plateau, right/left, L, UHMWPE, CoCrMo, Rotating Hinge
Waldemar Link GmbH & Co. KG (Mfg Site) — recall Z-2934-2026
Brand Name: Elevaris/Spectra Medical Devices Product Name: Sodium Chloride Injection, 0.9
Spectra Medical Devices, Llc — recall Z-2873-2026
Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Art
Straumann USA LLC — recall Z-2935-2026
Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507; Solution Adm
Baxter Healthcare Corporation — recall Z-2766-2026
Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 7
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — recall Z-2931-2026
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, a
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — recall Z-2932-2026
Allura Xper FD. Model Numbers: 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — recall Z-2928-2026

About this data. Figures are drawn directly from the source and refresh on its own update schedule.