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© 2026Civic Data · Data sourced from OpenFDA, updated weekly · Not affiliated with the U.S. Food and Drug Administration · Always verify against official FDA sources before acting

  1. FDA Recalls
  2. ›Device Recalls

FDA Device Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 101–120 of 39,041 recalls

Class IIOngoing

BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use

Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

April 7, 2026 · DeviceView details →
Class IIOngoing

BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use

Becton Dickinson & Co.

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.

April 7, 2026 · DeviceView details →
Class IIOngoing

LVIS Intraluminal Support Device, REF/Outside Diameter(OD)xTotal Length(TL)xWorking Length(WL): 214022-CAS/4.0 mm x 22 mm x 18 mm, 214518-CAS/4.5 mm x 18 mm x 14 mm, 213517-CAS/3.5 mm x 17 mm x 13 mm

MICROVENTION INC.

Stent-assisted coiling device may due to commingling during manufacturing have dimensional nonconformance and/or incorrect device configuration. If device is oversized may lead to increased vessel wall stress, neointimal hyperplasia, vessel injury/rupture; if undersized may lead to incomplete expansion/malposition, acute stent thrombosis, distal embolization, ischemic neurological events

April 6, 2026 · DeviceView details →
Class IIOngoing

QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.

Quidel Corporation

Product has the potential for false positive results

April 6, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.

DEPUY (IRELAND)

The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.

April 3, 2026 · DeviceView details →
Class IIOngoing

One Step K in vitro diagnostic test REF: 81A4

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →
Class IIOngoing

Uric Acid in vitro diagnostic test REF: 31H0P

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →
Class IOngoing

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F

Windstone Medical Packaging, Inc.

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a potential for biohazard exposure, blood loss, infection. or air embolism.

April 2, 2026 · DeviceView details →
Class IIOngoing

QUCARE Total Cholesterol in vitro diagnostic test REF: 6407

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →
Class IIOngoing

One Step P in vitro diagnostic test REF: 8194

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →
Class IIOngoing

One Step pH in vitro diagnostic test REF: 31I4P

DFI Co., Ltd.

The devices were distributed without required FDA premarket clearance or approval.

April 2, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X, Xi Surgical System Model/Catalog Number: IS4000; IS4200 Software Version: N/A Product Description: he da Vinci Xi, X Surgical systems each consist of three main components: the Surgeon Console (SC), the Vision Cart (VC), and the Patient Cart (PC). The PC is the operative component of the system, and its primary function is to support the instrument arms and camera arm. Each system have four Universal Surgical Manipulators (USMs) also known as arms, which allow the surgeon to control up to three instruments and an endoscope simultaneously to perform surgical tasks (e.g. cutting, suturing, tissue approximation) in a variety of procedures. As the surgeon moves the hand controls within the console, the PC moves the robotic instruments within the patient in a corresponding manner. The da Vinci system and its software are designed such that instruments motion precisely tracks the motion inputs from the hand controls during surgery. Component: The affected part based on this recall, 380647-xx, USM, is a sub component of da Vinci Surgical Instrument

Intuitive Surgical, Inc.

Due to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking.

April 2, 2026 · DeviceView details →
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