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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 421–440 of 1,000 recalls

Class IITerminated

Flexor Check-Flo Introducer Ansel Modification Model Number: KCFW-6.0-18/38-45-RB-ANL0-HC Order Number/GPN: G44154 Intended to introduce therapeutic or diagnostic devices into the vasculature, excluding coronary and neuro vasculature.

Cook Inc.

Flexor Check-Flo Introducer Ansel Modification mislabeled. Products packaged with a label stating 6FR may contain a 7FR device and vice versa

November 12, 2021 · DeviceView details →

Class IITerminated

O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4

Orchestrate Orthodontic Technologies, Inc.

Due to product label/labeling being altered from it's approved state.

November 11, 2021 · DeviceView details →

Class IITerminated

PIVO Blood Collection Device 20G, REF: 202-0005

Velano Vascular

Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects range from no clinical effect up to bloodstream infection.

November 10, 2021 · DeviceView details →

Class IITerminated

Torosa Saline-Filled Testicular Prosthesis (Size Small)

Coloplast Manufacturing US, LLC

Product is mislabeled for size.

November 9, 2021 · DeviceView details →

Class IITerminated

Amplatzer Steerable Delivery Sheath

Abbott

Instructions for use were updated.

November 9, 2021 · DeviceView details →

Class IITerminated

Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJSR-101 Instructions for Use

Ossur Americas

Instructions for use were updated to include additional information to facilitate the selection and use of the collar device.

November 9, 2021 · DeviceView details →

Class IITerminated

RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.

Biomerieux Inc

There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.

November 9, 2021 · DeviceView details →

Class IITerminated

QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075); REF 691223

Qiagen Sciences LLC

The firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected cartridge is used, false-negative, false-positive, or both false-negative and false-positive results could occur.

November 8, 2021 · DeviceView details →

Class IITerminated

Boston Scientific ROTAPRO, Rotational Atherectomy System Console, Model numbers H74939309010 (US) and H74939309030 (EU).

Boston Scientific Corporation

Manufacturing instructions did not include the directions to not retest the pneumatic kit component of the ROTAPRO console upon failure, an internal nonconformity.

November 8, 2021 · DeviceView details →

Class IITerminated

Medical Device Identification Cards associated with Sprint Quattro Lead, Product/CFN 6935M72

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

November 8, 2021 · DeviceView details →

Class IITerminated

Medical Device Identification Cards associated with Astra XT DR Implantable pulse generator

Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)

The back of some Medical Device Identification Cards provided to patients were printed with an erroneous statement stating the following: "This patient has a complete MR conditional system implanted."

November 8, 2021 · DeviceView details →

Class IITerminated

DigniCap Delta Scalp Cooling System, Product Number: 900-1001, Labeling: The DigniCap Scalp Cooling System User Manual (PN: 0P1DDCD01M-EN_C / IFU 20190325-06-EN), DigniCap Delta Scalp Cooling Wrap (LAB 20190221-05-EN), DigniCap Delta Small Cooling Wrap (LAB 20200616-01-EN, Quick Reference Guide DigniCap Delta (IFU-20190327-02-EN), The DigniCap Scalp Cooling System Training Guide- Global (TR-20200104-05-EN), The DigniCap Scalp Cooling System Training Guide TR-2019-0801-05-US, DigniCap Delta Procedural Expectations- Global (TR-20191028-03-EN), DigniCap Delta Procedural Expectations TR- 20190721-02-US, DigniCap Delta Small Wrap Protocol Global(TR-20200728-02-EN), DigniCap Delta Small Wrap Protocol TR-20200714-01-US, DigniCap Delta Training Tips Global (TR-20200420-04-EN), DigniCap Delta Training Tips TR-20191202-05-US,

Dignitana, Inc.

Instructions for Use (IFUs) updated to include use of a headband is now recommended for all patients and instructions for the application of the headband. Additionally, IFU updated to include warnings for risk of condensation build up depending on environmental conditions with instructions.

November 5, 2021 · DeviceView details →

Class IITerminated

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Wright Medical Technology Inc

The package contents and package labeling do not match.

November 4, 2021 · DeviceView details →

Class IITerminated

regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

ROi CPS LLC

The kit contains a non-sterile needle.

November 4, 2021 · DeviceView details →

Class IITerminated

INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS

Wright Medical Technology Inc

The package contents and package labeling do not match.

November 4, 2021 · DeviceView details →

Class IITerminated

Leica Microsystems M220 F12 Microscope Systems

Leica Microsystems, Inc.

In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.

November 3, 2021 · DeviceView details →

Class IITerminated

The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck 27BD-23-EN / Steripath Gen2 Blood Collection System - 23G, Long Neck

Magnolia Medical Technologies, Inc.

Due to an uptick of complaints associated with premature needle retraction of blood collection system.

November 2, 2021 · DeviceView details →

Class IITerminated

Flex-Thread Inserter Shaft intended for Fibula intramedullary-intended to be used with the Inserter Draw Rod and Blue Ratchet Handle in order to facilitate the insertion of the Flex-Thread Nail System- Catalog Number: 8435-1

Flower Orthopedics Corporation

Mating incompatibility between the Inserter Shaft and the Inserter Draw Rod causing the inserter draw rod to bind and not rotate freely as intended surgeon may be unable to complete surgery unless a second set is available

November 2, 2021 · DeviceView details →

Class IITerminated

RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200

Randox Laboratories Ltd.

When calibrating using the standard provided in the kit, the change in absorbance is lower than expected generating internal quality control results high outside range

November 1, 2021 · DeviceView details →

Class IITerminated

Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.

Diversatek Healthcare

M-Catch Retrieval Nets, Part Number 1175-01 / Lot Number 001919, that were shipped between 9-27-2021 and 10-22-2021, may contain incorrect inner polybag labeling. The outer package labeling is correct.

October 29, 2021 · DeviceView details →

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