Medical DeviceJun 10, 2026
Fresenius Kabi USA The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — FDA Z-2274-2026
Potential for the Cassette Loading Lever to break.
Class IIFDA: OngoingFresenius Kabi USA, LLC
June 2026 recalls — page 12
These records include useful source details for the selected month.
Medical DeviceJun 10, 2026
Becton Dickinson & Company BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in recall — FDA Z-2248-2026
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Class IFDA: OngoingBecton Dickinson & Company
Medical DeviceJun 10, 2026
Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in recall — FDA Z-2254-2026
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Class IFDA: OngoingBecton Dickinson & Company
Medical DeviceJun 10, 2026
Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in., BDQuincke recall — FDA Z-2253-2026
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Class IFDA: OngoingBecton Dickinson & Company
Medical DeviceJun 10, 2026
B Braun Medical Spinal Needle procedure kits: Material Description (Material Number) 24GA recall — FDA Z-2276-2026
These procedure kits contain Bupivacaine Hydrochloride in Dextrose Injection, USP. The manufacturer of the Bupivacaine, Huons Co, Ltd., has issued a voluntary recall due to potential…
Class IFDA: OngoingB Braun Medical Inc
Medical DeviceJun 10, 2026
Oculus Technologies of Mexico, S.A. de C.V PhaseOne Antimicrobial Solution recall — FDA Z-2275-2026
The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product…
Class IIFDA: OngoingOculus Technologies of Mexico, S.A. de C.V.
Medical DeviceJun 10, 2026
Becton Dickinson & Company BDSpinal Tray with BDQuincke Needle 25 G x 3.5 in recall — FDA Z-2249-2026
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Class IFDA: OngoingBecton Dickinson & Company
Medical DeviceJun 10, 2026
Becton Dickinson & Company BDSpinal Tray with BDWhitacre Needle 25 G x 3.5 in recall — FDA Z-2255-2026
This is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is due to quality issues identified during…
Class IFDA: OngoingBecton Dickinson & Company
Medical DeviceJun 10, 2026
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1 recall — FDA Z-2291-2026
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceJun 10, 2026
Siemens Medical Solutions USA ARTIS Icono biplane, floor and ceiling.: ARTIS icono biplane recall — FDA Z-2206-2026
During patient examinations, the system may sporadically display a 0 x-ray dose administered to the patient. This behavior has only been observed during fluoroscopy and/or single-frame…
Class IIFDA: OngoingSiemens Medical Solutions USA, Inc
Medical DeviceJun 10, 2026
Philips Azurion 5M20, Model Numbers: 722228 with Software release R2.2.0, R2.2.1, R2.2.3 recall — FDA Z-2287-2026
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceJun 10, 2026
B. BRAUN MEDICAL INC. BPSK, BLOCKJOCKS TRAY recall — FDA Z-2264-2026
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
Class IIFDA: OngoingB Braun Medical Inc
Medical DeviceJun 10, 2026
CareFusion 303 BD Pyxis MedStation ES REF: 323 Medication cabinet recall — FDA Z-2298-2026
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceJun 10, 2026
Philips Azurion 7M12, Model Numbers: 722078, 722223 with Software release R2.2.0, R2.2.1 recall — FDA Z-2290-2026
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceJun 10, 2026
COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN UDI-DI code recall — FDA Z-2261-2026
Due to customer complaint regarding incorrect display box labeling.
Class IIFDA: OngoingCovidien LLC
Medical DeviceJun 10, 2026
B. BRAUN MEDICAL INC. NES1725KFXL SPINAL EPID CLOSED TIP CATH recall — FDA Z-2265-2026
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
Class IIFDA: OngoingB Braun Medical Inc
Medical DeviceJun 10, 2026
HiResolution" Bionic Ear System HiRes Ultra 3D CI HiFocus Mid Scala recall — FDA Z-2283-2026
Due to incorrect shelf-life expiration date.
Class IIFDA: OngoingAdvanced Bionics, LLC
Medical DeviceJun 10, 2026
CareFusion 303 BD Pyxis Anesthesia Station 4000 REF: 338 Medication cabinet recall — FDA Z-2300-2026
Fingerprint scanner may overheat to a temperature to cause 1st degree burn.
Class IIFDA: OngoingCareFusion 303, Inc.
Medical DeviceJun 10, 2026
B. BRAUN MEDICAL INC. CESK SHANDS JACKSONVILLE 20055717 recall — FDA Z-2269-2026
B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the…
Class IIFDA: OngoingB Braun Medical Inc
Medical DeviceJun 10, 2026
GE Medical Systems China Co MAC 5 A4 Resting ECG Analysis System 855001-001 recall — FDA Z-2306-2026
Software in development inadvertently made available for customer use. Use of this software version can result in clinical information being associated with the incorrect patient. This…
Class IIFDA: OngoingGE Medical Systems China Co., Ltd.
Medical DeviceJun 10, 2026
Philips Azurion 7B12/12, Model Numbers: 722067, 722225 with Software release R2.2.0, R2.2.1 recall — FDA Z-2288-2026
During the device phase of Roadmap Pro, a user may experience a dark image that is not clinically usable. The dark image may result after the user performs a pedal tap (shortly touching the…
Class IIFDA: OngoingPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceJun 10, 2026
Daavlin Distributing Company Phothera 200, Phototherapy Devices indicated for use to treat recall — FDA Z-2295-2026
Some of the Calibration/Output Certificates had the outputs reversed.
Class IIFDA: OngoingDaavlin Distributing Company
Medical DeviceJun 10, 2026
KAYSERBETTEN GMBH & CO. KG Pediatric care bed recall — FDA Z-2212-2026
If the adjustment functions of the hand control, as instructed in the Manual, are not locked with the provided key when the patient (child) is unattended, there is an increased risk that…
Class IFDA: OngoingKAYSERBETTEN GMBH & CO. KG
Medical DeviceJun 10, 2026
Stryker Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the recall — FDA Z-2282-2026
It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to…
Class IIFDA: OngoingStryker Corporation
How to use this monthly recall archive
Use this page to compare the recalls reported during the month, then open an individual record for the exact reason, classification, company, remedy or distribution information available from the official source. Monthly counts are descriptive, not a safety rating.