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 154 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 30 critical (Class I-equivalent) actions, 18 moderate recalls, and 2 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 44 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 Mar 6, 2024 to Mar 6, 2024, covering 11 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

Ref No: HITHSP04 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Medline Kits, trays, and packs labeled as follows: TRAY,L&D INSTRUMENT, REF DYNDL1550

Ref No: INS7260 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Colonoscope, Model Number PCF-H180AL.

Colonoscope, Model Number CF-HQ190L.

Centurion Kits, trays, and packs labeled as follows: MAINTENANCE FLUSH KIT/BLOOD DRAW, REF DT19335A

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Adult Mask, CO2 Detector, REF 2K8004C2

MEDLINE Kits, trays, and packs labeled as follows: a) ENDO KIT, REF DYKE1350D; b) PANENDOSCOPY-LF, REF DYNJ36728C; c) UMBILICAL VESSEL INSERTION, REF UVT1170; d) UMBILICAL VESSEL INSERTION, REF UVT1170H

Medline Kits, trays, and packs labeled as follows: a) BLOOD DRAW KIT, REF DYNDV2183A; b) LCPH LAB DRAW KIT, REF DYNDH1641A; c) LCPH LAB DRAW KIT, REF DYNDH1641AH; d) OB LAB COLLECTION KIT, REF DYNDH1719A;

Ref No: INS7270 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, Expiratory Filter, REF 2K8004F

Medtronic Duet External Drainage and Monitoring System, SmartSite, Injection Sites, REF 46914, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Ref No: INS7250 / Integra Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

Schiff Reagent, Hotchkiss-McManus, packaged in an amber glass bottle with a black polypropylene cap.

Colonoscope, Model Number PCF-Q180AL.

Ref No: 31156 / COMBO KIT CONTAINS INS-8301, INS-4500,INS-HITH. For access to the subarachnoid space or the lateral ventricles of the brain.

AirLife Adult Manual Resuscitator, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask, CO2 Detector, REF 2K8005C2

Centurion Kits, trays, and packs labeled as follows: CIRCUMCISION TRAY, REF DYNDA2271

MEDLINE TRAY care and cleaning kits and trays for Tracheostomy and Stomas, labeled as: a) STOMA & TRACH CLEANING KIT, REF DYNDJ1129; b) TRACH CARE TRAY, REF DYNDJ1057A; c) TRACHEOSTOMY CARE KIT, REF DYNDA1893A; d) TRACH CARE TRAY, REF DYNDA1482

MEDLINE Kits, trays, and packs labeled as follows: SERUM TEAR KIT, REF DYNDA1545

Medline Kits, trays, and packs labeled as follows: CHP WOUND IRRIGATION KIT, REF DYK1017614W

Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF

Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024

Centurion Kits, trays, and packs labeled as follows: EYE PREP KIT, REF ET1010

Medtronic Duet External Drainage and Monitoring System, Interlink Injection Sites, Lumbar Catheter, REF 46917, Sterile EO, Rx Only. Used to drain cerebrospinal fluid (CSF) as a means to reduce intracranial pressure and CSF volume.

Colonoscope, Model Number CF-HQ190I.

AirLife Adult Manual Resuscitator, 40" (1.0m) Oxygen Reservoir Tubing, without Mask, REF 2K8001

AirLife Adult Manual Resuscitator, Oxygen Reservoir Bag, without Mask, REF 2K8000,

Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.

In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

Colonoscope, Model Number PCF-HQ190L.

Centurion Kits, trays, and packs labeled as follows: BREAST BIOPSY KIT, REF MNS4360

Centurion Kits, trays, and packs labeled as follows: a) DIALYSIS ACCESSORY PACK W/O CATHETER, REF MNS10750A; b) DIALYSIS ON KIT, REF DT21235A; c) INFUSA PORT KIT, REF DYNDC3166A

INS7280 / Integra¿ Cranial Access Kit. For access to the subarachnoid space or the lateral ventricles of the brain.

USTAR II Hip System Press-Fit Curved Stem, RHS Ti Plasma Spray for the following reference numbers: REF: PE11151211 - 11x150mm, PE11151213 - 13x150mm, PE11151215 - 15x150mm, PE11151217 - 17x150mm, PE11151411 - 11x200mm, PE11151413 - 13x200mm, PE11151415 - 15x200mm, PE11151417 - 17x200mm,

Medline Kits, trays, and packs labeled as follows: WOUND CARE TRAY - LATEX-FREE, REF DYND06002

MEDLINE Kits, trays, and packs labeled as follows: DIALYSIS ON/OFF BNDLE -NO DRSG, REF DYNDC3088

Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170

Colonoscope, Model Number PCF-H190TL.

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