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.

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

39,794 recalls · Page 103 of 796

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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 7 critical (Class I-equivalent) actions, 43 moderate recalls, and 0 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 50 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 Nov 20, 2024 to Nov 20, 2024, covering 15 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

SECURE 250 mL EMPTY EVA CONTAINER With 2 Ports, REF 66045; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: ESJH012-07

Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02

Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05

SECURE 100 mL EMPTY EVA CONTAINER With 2 Ports, REF 66040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Halyard CPT PEDS ADULT CH PACK - Medical convenience kits Model Number: SHAN431-07

Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code 3570009

Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15

URINE COLLECTION VHC, SKU DYLAB1016; Component No. 503581

Clean Catch Kit, SKU DYKM1833A; Component No. 503581

Halyard OPEN HEART PACK MAIN - Medical convenience kits Model Number: ESJH003-02

Imed Products Imed EVA BAG, 500 mL, 2-PORTS, REF IM68050; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Brand Name: Atlan Product Name: Atlan A350XL Model/Catalog Number: 8621600 Software Version: Not Applicable Component: Not applicable

Halyard MANIFOLD CATH PACK - Medical convenience kits Model Number: VMED005-03

Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

Halyard UPPER EXTREMITY PACK - Medical convenience kits Model Number: PANJ002-02

Halyard CYSTO PDS - Medical convenience kits Model Number: GVVA002-05

VYGON 100 mL EMPTY EVA CONTAINER With 2 Ports, REF CMS-9601; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN 10706282)

SafeControl handset (a component of the Sentida bed which moves and positions the bed), Model Numbers: 01-011539, 01-011541, 01-01198

Boston Scientific POLARx FIT BALLOON CATHETER LT US, Material Number M004CRBS2160

Halyard TOTAL KNEE - Medical convenience kits Model Number: GRND008-09

Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 710001B0

Imed Products Imed EVA BAG, 150 mL, 2-PORTS, REF IM38040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item Number: 720001F0

Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Model Number: AVMD018

Halyard CPT CARDIAC CATH PACK - Medical convenience kits Model Number: SHAN430-02

Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number: 8211500 Software Version: Not applicable Component: Not applicable

Boston Scientific POLARx FIT BALLOON CATHETER LT OUS, Material Number M004CRBS2110

Halyard VAG HYSTERECTOMY BUNDLE PK - Medical convenience kits Model Number: LANC022-29

Halyard IVR VASCULAR PACK - Medical convenience kits Model Number: VAST027-08

Boston Scientific SMARTFREEZE CRYO CONSOLE: Console: Material Number M004CRBS4000; CONSOLE REFURB: Material Number M004CRBS400R0; CONSOLE HOSPITAL, Material Number M004CRBS400H0, CONSOLE ZERO, Material Number M004CRBS400Z0

Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01

Halyard INTERVENTIONAL TRAY - Medical convenience kits Model Number: PSSC004-03

CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A

Halyard EYE PLASTIC TRAY - Medical convenience kits Model Number: SAMM054-19

CORMIX 150 mL EMPTY EVA CONTAINER With 2 Ports, REF MS64040; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Halyard POST PARTUM TUBAL LIGATION - Medical convenience kits Model Number: LANC026-19

Halyard SHOULDER PACK - Medical convenience kits Model Number: PANJ005

Halyard ENDOVASCULAR - Medical convenience kits Model Number: VMED008-02

SECURE 50 mL EMPTY EVA CONTAINER With 2 Ports, REF 66042; An empty single-use pouch made of plastic intended to contain a fluid for intravenous (IV) administration.

Halyard ANTERIOR HIP PACK - Medical convenience kits Model Number: EUOR001-06

Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777

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