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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 121–140 of 1,000 recalls

Class IIOngoing

PALACOS MV+G pro 40; PALACOS MV+G pro 80. Model/Catalog Number: 5081290; 5081291. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

August 20, 2026 · DeviceView details →
Class IIOngoing

McKesson CONSULT hCG Urine Cassette, Model/ Part: FHC-A102/5001; Alere hCG Cassette (20 mIU/mL) in Urine, Model/ Part: FHC-A102/92210; Fisher Scientific Sure-Vue Serum/Urine¿hCG-STAT, Model/ Part: FHC-A202/23900531, FHC-A202/23900530; McKesson CONSULT Diagnostics hCG Urine Cassette, Model/ Part: FHC-A202/5002; Alere hCG Combo Cassette (20/10 mIU/mL) for Urine or Serum, Model/ Part: FHC-A202/92215; Cardinal Health hCG Combo Rapid Test Serum or Urine, Model/ Part: FHC-A202/B-1077-23; Medline hCG Combo Pregnancy Test Cassette, Model/ Part: FHC-A202/MPH22025HCG;

Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

August 20, 2026 · DeviceView details →
Class IIOngoing

PALACOS MV pro 40; PALACOS MV pro 80. Model/Catalog Number: 5150633; 5150635. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix). Component: N/A

Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

August 20, 2026 · DeviceView details →
Class IIOngoing

PALACOS R+G pro 40; PALACOS R+G pro 80. Model/Catalog Number: 5081288; 5081289. Radiopaque, poly(methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).

Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

August 20, 2026 · DeviceView details →
Class IIOngoing

CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-7600-24, 21-7609-24 OUS Product Codes: 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7609-24JP 21-7600-24JP 21-7609-24 21-7609-24 21-7600-24 21-7600-24 21-7609-24 21-7600-24 21-7600-24 21-7600-24 21-7609-24

ICU Medical, Inc.

Reservoirs may exhibit medication leakage at the joint between luer connector and tubing. Issue could result in delay or interruption of therapy, under delivery of medication, exposure to infectious or toxic agents, or air embolus.

August 20, 2026 · DeviceView details →
Class IIOngoing

Fisher Scientific Sure-Vue Urine hCG Strip, Model/ Part: FHC-101/23900527; McKesson CONSULT hCG Urine Test Dipstick CLIA Waived, Model/ Part:FHC-101/5000; Henry Schein One Step+ hCG Urine Strip Test, Model/ Part: FHC-101/9004072; Alere hCG Dipstick (25mIU/mL) in Urine, Model/ Part: FHC-101/92211; Cardinal Health hCG Dipstick Rapid Test CLIA Waived, Model/ Part: FHC-101/B-1077-21; Medline hCG Pregnancy Test Strip, Model/ Part: FHC-101/MPH11025HCG; Pro Advantage by NDC Urine Pregnancy Test Strip, Model/ Part: FHC-101/P080023;

Alere San Diego, Inc.

hCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result.

August 20, 2026 · DeviceView details →
Class IIOngoing

PALACOS R pro 40; PALACOS R pro 80. Model/Catalog Numbers: 5081286; 5081287. Radiopaque, poly (methyl methacrylate)-based (PMMA) bone cement, pre-filled into a mixing and application system, suitable for use with or without vacuum (ready to mix).

Heraeus Medical GmbH (Dental Division)

Potential for monomer liquid leakage.

August 20, 2026 · DeviceView details →
Class IIOngoing

REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM

Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

August 19, 2026 · DeviceView details →
Class IIOngoing

Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

August 19, 2026 · DeviceView details →
Class IIOngoing

Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/Catalog Number: CD-B610LA.

Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

August 19, 2026 · DeviceView details →
Class IIOngoing

Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.

Olympus Corporation of the Americas

Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,

August 19, 2026 · DeviceView details →
Class IIOngoing

REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM

Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

August 19, 2026 · DeviceView details →
Class IIOngoing

REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM

Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

August 19, 2026 · DeviceView details →
Class IIOngoing

Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector. Model/Catalog Number: CD-B620LA.

Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

August 19, 2026 · DeviceView details →
Class IIOngoing

NOxBOXi Nitric Oxide Delivery System.

NOXBOX LTD

Potential for oxygen tubing leaks due to failure of the tubing or tubing connection, which may lead to oxygen desaturation.

August 19, 2026 · DeviceView details →
Class IIOngoing

REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM

Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

August 19, 2026 · DeviceView details →
Class IIOngoing

Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector. Model/Catalog Number: CD-B612LA.

Olympus Corporation of the Americas

Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.

August 19, 2026 · DeviceView details →
Class IIOngoing

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

SEASPINE ORTHOPEDICS CORPORATION

The proximal thread depth of the spinal device is out of design specification.

August 19, 2026 · DeviceView details →
Class IIOngoing

Presource Packs containing Medtronic Microstream Components: Intubation Kit Catalog Numbers AN23366084 AN23366085 AN2336608H AN2336608J Intubating Bag Kit Catalog Number OMSVM4166A Intubation UH Kit Catalog Number AN2336608G

Cardinal Health 200, LLC

Kits contain Microstream components. Medtronic issued an update to the Instructions for Use of these components due reports of difficulty in disconnecting the adapter from the patient's endotracheal tube to perform a procedure. The issue can result in a delay to treatment and unintended extubation. The potential exists for respiratory failure, hypoxia, aspiration, or low oxygen saturation.

August 19, 2026 · DeviceView details →
Class IIOngoing

REF:B11LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 11X100MM

Stryker Sustainability Solutions

Reusable access port system may crack or seperate during use.

August 19, 2026 · DeviceView details →
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