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  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 421–440 of 1,000 recalls

Class IIOngoing

Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;

Becton, Dickinson and Company

Catheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.

April 8, 2026 · DeviceView details →
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

INZONE DETACHMENT SYSTEM, REF: M00345100950

Stryker Neurovascular

Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.

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

Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name: Intracavitary Remote Afterloading Applicator Product Description: The Fletcher CT/MR Shielded Applicator Set is intended for gynecological brachytherapy treatment of the cervix and endometrium.

Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

April 3, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Brachytherapy Applicator Product Name: Advanced Gynecological Applicator Product Description: The intended use of the Advanced Gynecological Applicator is intracavitary brachytherapy for cancer treatment of the cervix and endometrium. Optional needles can be placed for interstitial brachytherapy.

Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

April 3, 2026 · DeviceView details →
Class IIOngoing

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

Grace Medical, Inc.

Due to incorrect functional length on device labeling.

April 3, 2026 · DeviceView details →
Class IIOngoing

Brand Name: Geneva Product Name: Brachytherapy Applicator Product Description: The device is intended for intracavitary brachytherapy for cancer treatment of the cervix and the endometrium. Optional needles can be placed for interstitial therapy.

Elekta, Inc.

Due to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient.

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 →
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