How many recalls has FDA Medical Devices issued?

FDA Medical Devices has issued 39,794 recalls tracked in our database. These include both active and historical recall actions. New recalls are added as they are published by the agency.

What types of products does FDA Medical Devices recall?

FDA Medical Devices is a federal agency responsible for product safety in its jurisdiction. Recalls cover products found to have safety defects, contamination, or regulatory violations. Each recall includes details about the affected product, hazard description, and remedy instructions.

What should I do if I own a recalled product?

Stop using the product immediately and follow the remedy instructions in the recall notice. This may include returning the product for a refund, receiving a free repair, or disposing of the product safely. Contact the manufacturer directly for specific remedy details.

2023 data Federal recall API Linked to agency record

FDA Medical Devices

All recall actions attributed to FDA Medical Devices in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.

PlainRecalls home → About this data

U.S. Food and Drug Administration — Medical device recalls

39,794 recalls · Page 92 of 796

Subscribe to new FDA Medical Devices recalls (RSS)

Official website →

FDA Medical Devices Recall Insight

According to PlainRecalls' agency ranking (distinct recall events, same sort as /agency), FDA Medical Devices sits #1 of 6 (1st among 6 issuing agencies) with 39,794 notices, about 38.1% of the 104,423-record archive. The agency's stated scope - U.S. Food and Drug Administration — Medical device recalls - determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 796 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Looking at the 50 records on this page alone, the severity distribution skews toward 3 critical (Class I-equivalent) actions, 47 moderate recalls, and 0 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 48 disclose a unit count, the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Jan 22, 2025 to Jan 29, 2025, covering 19 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories, for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Medical Devices's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions, medical, automotive, or childcare, always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).

FDA Medical Devices Recall Insight

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Tegaderm Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3080LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600022, 132 cases affected. Component: No

Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dressing & 3mL CHG One Step Applicator CS/30 Model/Catalog Number: DC3077LF Software Version: N/A Product Description: Dressing change kit, case of 30, lot #600018, 66 cases affected. Component: No

Otological Ventilation Tube - T-Tube 9mm - Double - Silicone; Product Code: NZ3309-2;

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757

BD Pyxis MedStation 4000 Main, REF 303

Otological Ventilation Tube - T-Tube 12mm - Silicone; Product Code: NZ3312;

Bodor P and C series laser cutting machines

BD Pyxis Med 4000 Auxiliary (AUX), REF 314

BD Pyxis MedStation ES (Med ES Main), REF 323

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810 Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

Baxter Solution Set with Duo-Vent Spike, REF 2R8404

Baxter Clearlink System Solution Set with Duo-Vent Spike, REF 2R8538

Otological Ventilation Tube - T-Tube 6mm - Silicone; Product Code: NZ3306/NZ3306-2;

EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)

BD Pyxis MedStation 4000 AUX, REF 306

Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Model/Catalog Number: TM6180CP Software Version: N/A Product Description: Dressing change tray, case of 20, lot #600032, 50 cases affected. Component: No

CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 828820. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)

BD Pyxis MedStation ES AUX, REF 324

Otological Ventilation Tube - T-Tube 12mm - Double - Silicone; Product Code: NZ3312-2;

Otological Ventilation Tube - Donaldson - Double - Blue Silicone; Product Code: NZ3321-2;

CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: 828810PL. Implantable device that provides constant intraventricular pressure and drainage of CSF for the management of hydrocephalus.

PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

Welch Allyn, Inc., Life 2000 Ventilation System, REF BT-20-0002

Augustine Surgical Inc. HOT DOG PATIENT WARMING, Temperature Management Controller, Single Port, Models: 1) WC77V; 2) WC77V-DEMO; 3) WC77V-R; used in conjunction with Warming Blankets and Mattresses, veterinary use.

8MM,HORIZON SMALL CLIP APPLIER,IS4000¿ REF 470401

X-Flow prostatectomy catheter, Device Reference Numbers AB6022, AB6024, AB6118, AB6120, AB6122, AB6124, AB6220, AB6222, AB6224, AB6318, AB6320, AB6322, AB6324, AB6418, AB6420, AB6422, AB6424, AB6522, AB6524, AB6A18, AB6A20, AB6A22, AB6A24, AB6C18, AB6C20, AB6C22, and AB6C24.

8MM,MEGA SUTURECUT ND,IS4000 REF 471309

8MM, LARGE NEEDLE DRIVER, IS4000 REF 470006

8MM,PROGRASP FORCEPS,IS4000 REF 471093

ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE BACKHAUS TWL CLP STER 3.5 CS50, Model Number 96-2630; 2) ECONO STERILE BACKHAUS TWL CLP STER 5.25 25, Model Number 96-2636; general purpose clips

Olympus MAJ-891 Forceps/Irrigation Plug (Isolated Type). Model/Catalog Number: MAJ-891. This instrument is designed to be attached to the instrument channel port of Olympus endoscopes to allow both irrigation and the use of endo-therapy accessories.

Cook Medical Biodesign Hiatal Hernia Graft, REF C-PHR-7X10-U, REF G31455, Sterile; and

Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.

Nearby Agencies

FDA Food Safety

FDA Drug Safety

CPSC

NHTSA

Learn More About Recalls

How the US Recall System Works

Understanding Severity Classes

What to Do When a Product Is Recalled