Open, ClassifiedPosted Apr 2, 2026·Initiated Mar 3, 2026
OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem
Reason: Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873
may identify incorrect organism due to inconclusive result from ambiguous color reactions in wells.
Root cause: Under Investigation by firm
Recalling firm: Oxoid Australia Pty LimitedType: Gram Positive Identification PanelDistribution: US Nationwide distribution in the states of GA and CA.Recall #Z-1766-2026
Open, ClassifiedPosted Apr 2, 2026·Initiated Feb 27, 2026
SIGNA Premier systems
Reason: Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous (steel) fittings instead of non-ferrous (brass) fittings on the magnet rear and if system is accessed to perform service while the magnet is ramped, the magnetic field could attract the ferrous fittings potentially resulting in personnel injury.
Root cause: Nonconforming Material/Component
Recalling firm: GE Healthcare LLCType: System, Nuclear Magnetic Resonance ImagingDistribution: Worldwide - US Nationwide distribution in the states of CA, MA, NJ, NY, OH, SD, TX, VA, PR and the countries of Sweden, Switzerland, United Kingdom, Vietnam, China, Norway, Portugal, Spain, France, Germany, Greece, Korea, Republic ofRecall #Z-1767-2026
Open, ClassifiedPosted Apr 2, 2026·Initiated Feb 27, 2026
Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock, Catalog Number 1180100777
Reason: The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.
Root cause: Under Investigation by firm
Recalling firm: Cardinal Health 200, LLCType: Syringe, PistonDistribution: Worldwide distribution - US Nationwide and the country of Canada.Recall #Z-1768-2026 Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 18, 2026
Blue Ventilator Adapter Module, single-patient use circuit, Product Code M07937. Accessory to Baxter Volara Respiratory Therapy system.
Reason: Urgent Medical Device Correction for the Volara system single-patient use circuit due to the potential that patients or caregivers may be unaware of a possible decrease in oxygen levels (oxygen desaturation), or potential lung tissue injury from overexpansion (barotrauma) when the Volara device is used in the home care environment. This correction is providing the home caregiver specific instructions for use.
Root cause: Process control
Recalling firm: Baxter Healthcare CorporationType: Device, Positive Pressure Breathing, IntermittentDistribution: FloridaRecall #Z-1637-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
Airway Exam Kit, DYKE1796
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Circuit, Breathing (W Connector, Adaptor, Y Piece)Distribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1705-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
Medline convenience kits containing Olympus biopsy valves:
1. BRONCH PACK, DYKE2096
2. NON MB BRONCHOPSCOPY CCH LH PK, DYNJT6182
3. PULMONARY BRONCH PACK, DYNDA2861A
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Tracheobronchial Suction Catheter KitDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1706-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
THORACIC ROBOTS, DYNJ908777B
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1707-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
Medline kits containing Olympus biopsy valves:
1. BAL KIT, DYNDA2137B
2. ENDO KIT, DYKE1915
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Central Venous Catheter TrayDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1708-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
Medline kits containing Olympus biopsy valves:
1. BRONCHOSCOPY, DYNJ900898I DYNJ901922G
2. FLEXIBLE BRONCHOSCOPY KIT, DYKM1417I DYKM1417J
3. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146A
4. RIGID KIT, DYNDA2138A
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1709-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
Medline kits containing Olympus biopsy valves:
1. BRONCH PROCEDURE KIT, DYKE2091
2. BRONCHSCOPY, DYNJ900898G DYNJ901922I
3. BRONCHSCOPY PACK, DYNJ38313B
4. BRONCHOSCOPY PACK 0120367-LF, DYNJ32750G DYNJ32750I
5. KIT, WR THORACIC, DYNJ911252
6. LARYNGOSCOPY/BRONCHOSCOPY PACK, DYNJ58146B
7. LEX THORACIC, DYNJ902016K DYNJ902016L
8. ORGAN PROCUREMENT, DYNJ908686
9. PULMONARY PACK, DYKE1859
10. THORACIC, DYNJ901666L
11. THORACIC ROBOTICS, DYNJ908777A
12. THORACOTOMY/THORACOSCOPY, DYNJ900482N DYNJ900482O
13. XPS, DYNJ907605
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1710-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Feb 16, 2026
MEDLINE ANTERIOR HIP PACK
DYNJ64672B
Reason: Kits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the slit of single use biopsy valves. Potential consequences associated with detachment of fragments from valve include foreign body in patient's tracheobronchial tree, which may require intervention for removal. Other potential consequences include inflammatory response, hypoxia, and prolongation of procedure.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution in the states of CA, FL, IL, IN, KY, MA, MD, MT, NY, OH, PA, TN, TX.Recall #Z-1711-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle System Starter Kit 12G (for Aurora Trackers), Part Number 667-149
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1731-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle System Starter Kit 14G (for Aurora Trackers), Part Number 667-150
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1732-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle System Starter Kit 16G(for Aurora Trackers), Part Number 667-151
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1733-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle System Starter Kit 18G (for Aurora Trackers), Part Number 667-152
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1734-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle Sensor - 12G (for Aurora Trackers), Part Number 667-156
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1735-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle Sensor - 14G(for Aurora Trackers), Part Number 667-157
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1736-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle Sensor - 16G(for Aurora Trackers), Part Number 667-158
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1737-2026
Open, ClassifiedPosted Apr 1, 2026·Initiated Mar 2, 2026
eTRAX Needle Sensor - 18G (for Aurora Trackers), Part Number 667-159
Reason: There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified on the user interface.
Root cause: Software change control
Recalling firm: Civco Medical Instruments Co. Inc.Type: System, Imaging, Pulsed Echo, UltrasonicDistribution: US States: OH, PA, WA. China.Recall #Z-1738-2026
Open, ClassifiedPosted Mar 31, 2026·Initiated Feb 18, 2026
Purge Cassette, sold within Impella Pump Sets and Individually Packaged. Labeled and distributed in the below configurations and corresponding product codes.
1. Purge Cassette, 5 Pack; Product Code: 0043-0003.
2. Impella RP US Pump Set; Product Code: 004334.
3. Purge Cassette, Packaged; Product Code: 0043-0002. Also included inside Product Code 0043-0003 above. Product Code 0043-0002 also includes innermost packaged product with Product Code 0043-0001.
4. Impella 2.5 Set; Product Code: 004413 (Customer facing code 005040).
5. Impella RP Pump Set, EU; Product Code: 0046-0011.
6. Impella CP Pump Set, EU; Product Code: 0048-0002.
7. Impella CP Pump Set BR; Product Code: 0048-0002-BR.
8. Impella CP Smart Assist Set, EU; Product Code: 0048-0014 (Also inclusive of codes 0048-0047 and 1000402 listed below).
9. Impella CP Smart Assist Set, Canada; Product Code: 0048-0044.
10. Impella CP Smart Assist Set APAC; Product Code: 0048-0047 (inclusive under code 0048-0014).
11. Impella 5.0 IMC Pump Set EU; Product Code: 005060.
12. Impella 5.5 with SmartAssist Set, EU; Product Code: 0550-0002.
13. Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004.
14. 5.5 Accessories AU; Product Code: 1000362.
15. Impella CP Smart Assist Set; Product Code: 1000402 (inclusive under code 0048-0014).
Reason: Increased risk of purge leaks with Generation 1 purge cassettes.
Root cause: Device Design
Recalling firm: Abiomed, Inc.Type: Temporary Non-Roller Type Left Heart Support Blood PumpDistribution: Worldwide distribution.Recall #Z-1589-2026