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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 3461–3480 of 39,430 recalls

Class IIOngoing

ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.

Mckesson Medical-Surgical Inc. Corporate Office

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL

Mckesson Medical-Surgical Inc. Corporate Office

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

April 24, 2025 · DeviceView details →
Class IIOngoing

ORTHO CLINICAL DIAGNOSTICS INC TOTAL BILI-ALKP XT (L-SEQUESTER) (300/PK) REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

April 24, 2025 · DeviceView details →
Class IIOngoing

BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.

Mckesson Medical-Surgical Inc. Corporate Office

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

April 24, 2025 · DeviceView details →
Class IIOngoing

ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.

Mckesson Medical-Surgical Inc. Corporate Office

transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

April 24, 2025 · DeviceView details →
Class IIIOngoing

Apo B Reagent, REF: OSR6143

Beckman Coulter Ireland, Inc.

The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.

April 23, 2025 · DeviceView details →
Class IICompleted

MIRA SURGICAL SYSTEM, Table mounted miniaturized electromechanical surgical system, Catalog Number MIRA-CAP-110, Software Version 4.0.3

VIRTUAL INCISION CORPORATION

The MIRA Surgical System Software Version 4.0.3 loaded on the Surgeon Control Console may have the potential to exhibit interrupted motion on the display screen, caused by a software latency between the movement of the hand controllers and the movement of the Surgical Minibot arms.

April 23, 2025 · DeviceView details →
Class IIOngoing

Palindrome Precision Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

Potential breach of sterile barrier packaging.

April 23, 2025 · DeviceView details →
Class IIOngoing

Palindrome Precision HSI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

Potential breach of sterile barrier packaging.

April 23, 2025 · DeviceView details →
Class IIOngoing

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software version 1.20

Beckman Coulter, Inc.

A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

April 23, 2025 · DeviceView details →
Class IIOngoing

Palindrome Precision SI Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

Potential breach of sterile barrier packaging.

April 23, 2025 · DeviceView details →
Class IIOngoing

MAHURKAR Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

Potential breach of sterile barrier packaging.

April 23, 2025 · DeviceView details →
Class IIOngoing

DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, running software versions 1.20

Beckman Coulter, Inc.

A new motor/encoder and cable was introduced into instruments manufactured starting with serial number 300141 incorrectly. This incorrect installation is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.

April 23, 2025 · DeviceView details →
Class IIOngoing

Palindrome Precision H Chronic Hemodialysis Catheter Sport Pack. Radiopaque urethane catheter.

Mozarc Medical US LLC

Potential breach of sterile barrier packaging.

April 23, 2025 · DeviceView details →
Class IOngoing

Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ADD A PACK, SKU DYNJ30926O 2. CRANIOTOMY, SKU CDS983611N 3. CRANIOTOMY CDS, SKU CDS983467J 4. CRANIOTOMY PACK, SKU DYNJ85807A, DYNJ85927 5. MAJOR CRANIOTOMY PACK, SKU DYNJ82007A

MEDLINE INDUSTRIES, LP - Northfield

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

April 22, 2025 · DeviceView details →
Class IIOngoing

3M Ranger Irrigation Fluid Warming Set, REF 24750

3M Company

Notice was issued to clarify flow rates related to the inlet fluid temperature.

April 22, 2025 · DeviceView details →
Class IOngoing

Medline Kits containing Codman Disposable Perforator 14 mm: CRANIOTOMY, SKU DYNJ35349C

MEDLINE INDUSTRIES, LP - Northfield

Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.

April 22, 2025 · DeviceView details →
Class IIOngoing

Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component

C-RAD POSITIONING AB

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

April 22, 2025 · DeviceView details →
Class IOngoing

Endopath Echelon Vascular White Reload for Advanced Placement Tip (35mm, 4 row); Product code VASECR35

Ethicon Endo-Surgery Inc

Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.

April 22, 2025 · DeviceView details →
Class IIOngoing

ICU Medical Plum Solos, Item number 400011001; infusion pump

ICU Medical, Inc.

Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

April 22, 2025 · DeviceView details →
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