How many recalls has FDA Medical Devices issued?

FDA Medical Devices has issued 39,096 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

39,096 recalls · Page 224 of 782

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FDA Medical Devices Recall Insight

PlainRecalls tracks 39,096 recall actions attributed to the FDA Medical Devices in our federal recall index. Across the full PlainRecalls database of 100,165 records spanning 1995 through the present, FDA Medical Devices accounts for roughly 39.0% of all indexed recalls. 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 782 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 5 critical (Class I-equivalent) actions, 41 moderate recalls, and 4 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 Jul 27, 2022 to Aug 10, 2022, covering 31 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).

Moderate Aug 10, 2022

Legacy Base for Dual Bed Configurations

Craftmatic Industries, Inc.

Critical Aug 10, 2022

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished K…

North American Diagnostics

Moderate Aug 10, 2022

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounte…

Medtronic Inc

FDA Medical Devices Recall Insight

Legacy Base for Dual Bed Configurations

SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test, Oral Rapid Antigen Test, SML LDT Kits, SML Brand Finished K…

Medline Sprinter OTW, Model/Catalog Number SPR2512W; The Sprinter Over-the-Wire balloon dilatation catheter has a coaxial shaft with a balloon mounte…

Centricity PACS Software Version 7.0 SP0.0.4.7

AquaC UNO H [120V, 60Hz, 1700VA, Fresenius US-Version: 24-0970-1 Vivonic Part Number: G02000966-US

Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1

Cobalt Implantable Cardioverter Defibrillators with Cardiac Resynchronization Therapy (CRT-D)

Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS, Model Number CDS984642, b. VASCULAR CDS, Model Number DYNJ902880J, c. VASCULAR CDS…

REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)

REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL

Medline convenience kits: a. VENOUS ACCESS PACK-LF, Model Number DYNJ36725B, Lot codes: 19UBB149, b. KIT LB SHUNT, Model NumberDYNJ905860A, Lot cod…

REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL

nordicBrainEX, software versions 2.21 through 2.3.10

Medline Convenience kits labeled as: a. WET SKIN PREP TRAY, b. SKIN PREP TRAY W/CHG Model/Catalog Number: Model numbers: a. DYNDP1127A, b. DYNDP11…

Da Vinci S/Si Large Clip Applier, Model 420230 Da Vinci S/Si Medium-Large Clip Applier, Model 420327 Da Vinci S/Si Small Clip Applier, Model 420003

AquaC UNO H [120V, 60Hz, 1000VA, Fresenius US-Version: 24-10VA-1 Vivonic Part Number: G02000970-US

X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)

Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK, b. KIT NEUR FUS LUM POST, c. KIT PEDI VP SHUNT, d. KIT STC NEURO SPINE GENERIC,…

Stryker 2.3mm Tapered Router, Catalog no. 5820-071-023 instrument used in craniotomy procedures.

ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abac…

etouchus, model no. ETM-G01. Noninvasive Blood glucose meter.

Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS, b. POST OP KIT, c. KIT NEURO FUS LUM POST SANSUR, d. KIT NEURO FUS LUM POST SANSUR , e. …

Brand Name: Medline Product Name: convenience kits labeled as: LAP CHOLE Model/Catalog Number: DYNJ907150

Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2, Ht 5/…

ZEISS Axio Observer 5 microscope, Product material no. 431006-9901-000

Da Vinci X/Xi Large Clip Applier, Model 470230 Da Vinci X/Xi Medium-Large Clip Applier, Model 470327 Da Vinci X/Xi Small Clip Applier, Model 47401

Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual Driver Needle…

TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet the requirements of intrauterine tissue removal. Model Number: 7209808

Revogene, Catalog no. 610210. IVD test instrument

Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm

CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.

Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF, Model DYNJ0689093V, b. EENT PACK, Model Number DYNJ62927 Model/Catalog Number: a. DYNJ0…

BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)

AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.

SIGNA Premier magnetic resonance scanner, model 5748519.

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the numb…

ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: …

BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)

Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD

ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.

Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, …

NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 …

MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441

Nexiva with Single BD Connecta Stopcock Version (Pink) Catalog No. 383687 (OUS)

LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number 1009-9050-000.

(1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left, Product #7142016…

Soluble Transferrin Receptors Calibrator Series (STFR CAL), Catalog Number TF10161. 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