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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 3481–3500 of 39,430 recalls

Class IOngoing

Medline Kits containing Codman Disposable Perforator 14 mm: 1. CRANI ACCESSORY PACK SKU DYNJ59270 2. CRANI PACK-LF SKU DYNJ44805M 3. CRANIOTOMY SKU CDS982719V CDS982719W DYNJ904168F DYNJ908404B DYNJ908723A DYNJ908723C 4. CRANIOTOMY #IMF 56646-LF SKU DYNJVB91001A 5. CRANIOTOMY CDS SKU CDS981888X CDS983467I 6. CRANIOTOMY PACK-LF SKU DYNJ09882G DYNJ09882I 7. CRANIOTOMY S NASSAU SKU DYNJ905879G 8. MHC CRANIOTOMY SKU DYNJ903713K DYNJ903713L 9. PAD CRANIOTOMY SKU DYNJ902149J

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

ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001 , and 3) 400021003; 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 →
Class IITerminated

BIB Balloon in Balloon Dilatation Catheter. Model Number: 420

Numed Inc

Balloon extension lumens are not printed correctly. Specifically, the inner balloon inflation hub was labeled as the outer balloon, and the outer balloon inflation hub was labeled as the inner balloon.

April 21, 2025 · DeviceView details →
Class IIOngoing

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862

Becton Dickinson Infusion Therapy Systems, Inc.

Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.

April 21, 2025 · DeviceView details →
Class IIOngoing

LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREMITY, Model: NCEX20J; TOTAL KNEE PACK, Model: NCTK31K; TOTAL KNEE PACK, Model: NCTK31L All convenience kits contain Specialist Blend Cast Padding, Item: QTX30-322NS

American Contract Systems, Inc.

Test results for cast padding component included in procedure trays shows Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals exceeded residual limits, which may lead to a possible loss or lack of functionality that may lead to a delay or prolonged treatment/procedure/therapy.

April 21, 2025 · DeviceView details →
Class IIOngoing

Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Capnia Inc

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

April 21, 2025 · DeviceView details →
Class IOngoing

Bard¿ Single Intragastric Linton Balloon Tube, REF: 0092740

C.R. Bard Inc

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

April 17, 2025 · DeviceView details →
Class IIOngoing

Check=Flo Performer Introducer, 10.0Fr, Reference Part Number(RPN) REF RCFW-10.0-0-38-30-RB, Order Number (GPN) REF G08686,

Cook Incorporated

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

April 17, 2025 · DeviceView details →
Class IIOngoing

Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,

Cook Incorporated

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.

April 17, 2025 · DeviceView details →
Class IOngoing

Bard¿ Blakemore Esophageal-Nasogastric Tube (Intermediate)REF: 0092300

C.R. Bard Inc

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

April 17, 2025 · DeviceView details →
Class IIOngoing

Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)

Cook Incorporated

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

April 17, 2025 · DeviceView details →
Class IOngoing

Bard¿ Blakemore Esophageal-Nasogastric Tube (Child) REF: 0092110

C.R. Bard Inc

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

April 17, 2025 · DeviceView details →
Class IOngoing

Bard Minnesota Four Lumen Esophagogastric Tamponade Tube, REF:0092220 18 Fr. (6mm, 7/32"), 41" Length (104cm) with 8" (20.3cm) Balloon X-Ray Opaque Rubber

C.R. Bard Inc

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

April 17, 2025 · DeviceView details →
Class IOngoing

Bard Blakemore Esophageal-Nasogastric Tube (Adult) REF: 0092100

C.R. Bard Inc

Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons.

April 17, 2025 · DeviceView details →
Class IIOngoing

WB XL Anatomic Healing Abutment XC. Endosseous Dental Implant Abutments.

Straumann USA LLC

Incorrect blister labelling.

April 17, 2025 · DeviceView details →
Class IICompleted

VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test

Luminex Corporation

It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.

April 16, 2025 · DeviceView details →
Class IIOngoing

Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

Remote Diagnostic Technologies Ltd.

software issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.

April 16, 2025 · DeviceView details →
Class IIOngoing

Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

Remote Diagnostic Technologies Ltd.

Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot after intermittent connection with Smart Mount, 4) 12-lead ECG measurements with Louvain algorithm and software before vx.36 could produce inaccurate rhythm/morphology statements.

April 15, 2025 · DeviceView details →
Class IIOngoing

Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

Siemens Healthcare Diagnostics, Inc.

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

April 15, 2025 · DeviceView details →
Class IIOngoing

ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

Siemens Healthcare Diagnostics, Inc.

Certain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference interval due to calibrator instability resulting in increased positive bias.

April 15, 2025 · DeviceView details →
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