Open, ClassifiedPosted Nov 7, 2024·Initiated Oct 11, 2024
Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometer
Reason: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Root cause: Software design
Recalling firm: Baxter Healthcare CorporationType: Spirometer, DiagnosticDistribution: Worldwide distribution.Recall #Z-0324-2025
Open, ClassifiedPosted Nov 7, 2024·Initiated Oct 11, 2024
Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagnostic Computer
Reason: There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this could lead to a mismatch of the patients identification with their physiological data.
Root cause: Software design
Recalling firm: Baxter Healthcare CorporationType: ElectrocardiographDistribution: Worldwide distribution.Recall #Z-0325-2025
Open, ClassifiedPosted Nov 7, 2024·Initiated Oct 15, 2024
Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
Reason: The Bipolar assembly contains an oversized Retainer Ring.
Root cause: Under Investigation by firm
Recalling firm: Smith & Nephew, Inc.Type: Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedDistribution: International distribution to the countries of Australia, Belgium, Canada, Germany, Italy, Panama, Poland, Spain, and Turkey.Recall #Z-0326-2025
Open, ClassifiedPosted Nov 6, 2024·Initiated Sep 25, 2024
Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 911933,
Diameter / 14 Gauge, containing 6 inner boxes labeled REF 911761, Disposable Biopsy Needle Kit for Leksell Stereotactic System. Each inner box of REF 911761 contains a Tyvek bag labeled REF 912465, Disposable Biopsy Needle and Aspirator Tube. The system is used for for localization and diagnosis of intracranial disorders and their surgical treatment including radiosurgery and stereotactic radiation therapy.
Reason: Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the inside of the biopsy needle. The material in the debris is stainless steel, same material as the biopsy needle. No debris has been found on the outer parts of the biopsy needles.
Root cause: Under Investigation by firm
Recalling firm: Elekta Instrument ABType: Neurological Stereotaxic InstrumentDistribution: US: AZ, TX, FL, CA, NY, GA, VA, NJ, MO, PA, WA,Recall #Z-0227-2025 Open, ClassifiedPosted Nov 6, 2024·Initiated Sep 30, 2024
The Access Cortisol assay is a paramagnetic particle, chemiluminescent
immunoassay for the quantitative determination of cortisol levels in human
serum, plasma (heparin, EDTA) and urine using the Access Immunoassay
Systems.
Reason: The Access Cortisol assay protocol file (APF) applies an incorrect calibration curve acceptance parameter at the S1 calibrator level that can lead to a high rate of calibration failures which can vary by reagent lot number. Calibration failure would lead to delay of measurement results reporting and potential injuries.
Root cause: Process design
Recalling firm: Beckman Coulter, Inc.Type: Radioimmunoassay, CortisolDistribution: Worldwide distribution.Recall #Z-0313-2025
Open, ClassifiedPosted Nov 6, 2024·Initiated Apr 29, 2022
Adult Cap-ONE Biteblock REF YG-227T
The cap-ONE Biteblock is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 20mm bite block, during endoscopy type procedures. The device is intended for single patient use only.
Reason: Due to products being shipped/distributed to customers after the products expiration date had past.
Root cause: Process control
Recalling firm: Nihon Kohden America IncType: Analyzer, Gas, Carbon-Dioxide, Gaseous-PhaseDistribution: U.S. Nationwide distribution in the states of CA, GA, ID, KY, MA, MO, NC, OR, and UT.Recall #Z-0314-2025 Open, ClassifiedPosted Nov 6, 2024·Initiated Sep 25, 2024
intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB
Buffer, Catalog Number: IPBF5009G20;
ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60;
IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20;
DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60
Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
Reason: Kits containing the DAB chromogen buffer, intended for use in either manual or automated Immunohistochemistry (IHC) staining protocols, may produce weak to no staining, which may lead to test failure requiring the test to be repeated.
Root cause: Nonconforming Material/Component
Recalling firm: Biocare Medical, LLCType: General Purpose ReagentDistribution: US Nationwide distribution in the states of MA, AZ, CT, NY, FL, NC, IN, IL, MO, CO, TX, CA, MI, PR, PA, MD, AL, OH, KY.Recall #Z-0315-2025
Open, ClassifiedPosted Nov 5, 2024·Initiated Oct 3, 2024
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Root cause: Under Investigation by firm
Recalling firm: DeRoyal Industries IncType: Kit, Surgical Instrument, DisposableDistribution: US Nationwide distribution in the state of OH.Recall #Z-0306-2025
Open, ClassifiedPosted Nov 5, 2024·Initiated Oct 3, 2024
DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Root cause: Under Investigation by firm
Recalling firm: DeRoyal Industries IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-0307-2025
Open, ClassifiedPosted Nov 5, 2024·Initiated Oct 3, 2024
DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06
Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Root cause: Under Investigation by firm
Recalling firm: DeRoyal Industries IncType: General Surgery TrayDistribution: US Nationwide distribution in the state of OH.Recall #Z-0308-2025
Open, ClassifiedPosted Nov 5, 2024·Initiated Oct 3, 2024
DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Root cause: Under Investigation by firm
Recalling firm: DeRoyal Industries IncType: Laparoscopy KitDistribution: US Nationwide distribution in the state of OH.Recall #Z-0309-2025
Open, ClassifiedPosted Nov 5, 2024·Initiated Sep 17, 2024
MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00-
0295-01
Reason: There is discrepant labeling on the inner and outer packaging of the device.
Root cause: Error in labeling
Recalling firm: Datascope Corp.Type: System, Balloon, Intra-Aortic And ControlDistribution: International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.Recall #Z-0311-2025
Open, ClassifiedPosted Nov 4, 2024·Initiated Oct 3, 2024
Medtronic DLP Aortic Root Cannula with Flow-Guard, REF 11012; for use in cardiopulmonary bypass surgery
Reason: There is the potential for a potential sterility breach for three lots of the DLP Aortic Root Cannula due to a misaligned seal
Root cause: Process control
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: US: NY, OH, IL, NJ, MI, TN, WI, Australia, and SingaporeRecall #Z-0289-2025
Open, ClassifiedPosted Nov 1, 2024·Initiated Sep 24, 2024
Brand Name: Vial2Bag Advanced
Product Name: Vial2Bag Advanced 20mm Admixture Device
Model/Catalog Number: 6070030
Software Version: Not applicable
Product Description: The Vial2Bag Advanced 20mm Admixture Device is a single use, fluid transfer device that allows for the reconstitution and transfer of fluids from drug vials into the IV bag containing infusion solution, through the IV bag administration port. The device consists of the body, Protector, IV Port, and an integrated vial adapter. The device is provided as a sterile, non-pyrogenic product. The device is intended to be used with standard drug vials with a seal diameter of 20mm and an elastomeric stopper. The Vial2Bag Advanced 20mm Admixture Device is designed to work with a standard 50, 100, or 250mL IV bag and an external IV administration set.
The device does not contain any medicinal substances and there are no additional accessories needed or provided with the Vial2Bag Advanced 20mm Admixture Device for the device to meet its intended purpose.
Component: No
Reason: Due to packaging damage from heat exposure during shipping/transportation that may result in a breach in the sterile barrier.
Root cause: Environmental control
Recalling firm: West Pharmaceutical Services AZ, Inc.Type: Set, I.V. Fluid TransferDistribution: A U.S. Distributor, Progressive Medical Inc. (PMI) currently supplies the Vial2Bag Advanced 20mm Admixture Device to hospitals in the U.S. (end user). PMI distributed the impacted Vial2Bag Advanced 20mm Admixture Device lots to the end users.
U.S.: Distributor located in MO
U.S. Customers: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NE, NM, NV, NY, OH, OK, OR, PA,SC, TN, TX, UT, WA, and WI.Recall #Z-0283-2025
Open, ClassifiedPosted Nov 1, 2024·Initiated Sep 17, 2024
Cartesion Prime, Digital PET-CT, Model: PCD-1000A/3D.004, PCD-1000A/3D, is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems.
Reason: When PET-CT system is executing reconstruction, if PET acquisition for another patient is performed (or PET reconstruction for another patient is performed from raw data processing), PET reconstruction control processing may hang up and PET reconstruction may stop as a result, which may necessitate repeat PET/CT examinations.
Root cause: Software design
Recalling firm: Canon Medical System, USA, INC.Type: System, Tomography, Computed, EmissionDistribution: US: NV, AR, MN, IA, IL, NC, LA, KS, MS, CA, AL, MD, CO, IN, TN, AZ, WI, VARecall #Z-0284-2025
Open, ClassifiedPosted Nov 1, 2024·Initiated Sep 17, 2024
Saphena Medical Venapax XL- Endoscopic Vessel Harvesting System for use in minimally invasive surgery allowing access for vessel harvesting and is primarily indicated for patients undergoing endoscopic surgery for arterial bypass.
Item Number: VPX4000 (7273)
Reason: A Gen 5 tail piece was assembled to a Gen 4 Finished Device, resulting in a 0.178" difference in the end of the endoscope slot to the end of the tail piece. This allows the scope to move further into the plastic sheath that runs the length of the device, resulting in an interference fit at the cone, may caus an extension in surgery
Root cause: Component change control
Recalling firm: Zimmer, Inc.Type: Electrosurgical, Cutting & Coagulation & AccessoriesDistribution: NationwideRecall #Z-0285-2025
Open, ClassifiedPosted Nov 1, 2024·Initiated Sep 24, 2024
epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
Reason: Siemens Healthcare Diagnostics Inc. has confirmed that a negative sodium bias may exist in one lot of epoc BGEM BUN Test Cards approximately 2 months prior to expiration. The observed maximum negative bias from internal testing is -10 mmol/L. No positive bias has been observed. Quality Control (QC) fluid may or may not detect the issue depending on the bias magnitude and the frequency of QC testing.
One customer complaint has been associated with this issue. No adverse events have been reported.
All affected lots have recently expired before the issuance of the recall.
Root cause: Under Investigation by firm
Recalling firm: Siemens Healthcare Diagnostics IncType: Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood PhDistribution: US Nationwide. Canada.Recall #Z-0286-2025 Open, ClassifiedPosted Nov 1, 2024·Initiated Sep 18, 2024
Americot 20-01S (1/4" x 1/4") or 6mm x 6mm: Neurological sponges for use in the protection of neural tissue during surgery.
Ref: 20-01S
x inches or 6mm x 6mm)
Component: N/A
Reason: Product defect where the X-ray detectable barium strip (aka radio-opaque marker) becomes detached from the sponge (pattie). May delay surgical process as the surgeon may require extra time to remove the markers from the surgical field.
Root cause: Process control
Recalling firm: American Surgical Company, LLCType: Neurosurgical PaddieDistribution: CA, IA, IL, MN, MO, NY, OH, VA
Foreign: Australia, Belgium, Hungry, Italy, Netherlands, Sweden, UK ItalyRecall #Z-0287-2025
CompletedPosted Nov 1, 2024·Initiated Sep 12, 2024
iotaSOFT Plus Drive Unit, REF IM-05. The iotaSOFT Insertion System is intended to aid the surgeon in placement of cochlear implant electrode arrays into a radiographically normal cochlea by controlling the speed of implant insertion.
Reason: Incorrect GTIN number.
Root cause: Process control
Recalling firm: Iotamotion IncType: Powered Insertion System For A Cochlear Implant Electrode ArrayDistribution: Distribution was made to Iowa. There was no government/military/foreign distribution.Recall #Z-0288-2025
CompletedPosted Oct 31, 2024·Initiated Jun 6, 2023
GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
1) 2082844-001-01040418;
2) 2082844-001-01046784;
3) 2082844-001-01052324;
4) 2082844-001-01052572;
5) 2082844-001-01055337;
6) 2082844-001-01065693;
7) 2082844-001-01069008;
8) 2082844-001-01073750;
9) 2082844-001-01086553;
10) 2082844-001-01089393;
11) 2082844-001-01090414;
12) 2082844-001-01092632;
13) 2082844-001-01111482;
14) 2082844-001-01115741;
15) 2082844-001-01122391;
16) 2082844-001-01128579;
17) 2082844-001-01128725;
18) 2082844-001-01131573;
19) 2082844-001-01140642;
20) 2082844-001-01165870;
21) 2082844-001-100397;
22) 2082844-001-100676;
23) 2082844-001-100740;
24) 2082844-001-100743;
25) 2082844-001-100744;
26) 2082844-001-101075;
27) 2082844-001-101149;
28) 2082844-001-101199;
29) 2082844-001-101202;
30) 2082844-001-101203;
31) 2082844-001-101356;
32) 2082844-001-101366;
33) 2082844-001-101656;
34) 2082844-001-102136;
35) 2082844-001-102589;
36) 2082844-001-102858;
37) 2082844-001-526493;
38) 2082844-001-533346;
39) 2082844-001-570904;
40) 2082844-001-615985;
41) 2082844-001-616544;
42) 2082844-001-674814;
43) 2082844-001-701655;
44) 2082844-001-704407;
45) 2082844-001-709042;
46) 2082844-001-857748;
47) 2082844-001-888278;
48) 2082844-001-941288;
49) 2082844-001-965539;
50) 2082844-001-978713;
51) 2082844-001-982099;
52) 2082844-001-982310;
53) 2082844-001-982985;
54) 2082844-001-982988;
55) 2082844-001-983509;
56) 2082844-001-983643;
57) 2082844-001-983679;
58) 2082844-001-984096;
59) 2082844-001-984948;
60) 2082844-001-987480;
61) 2082844-001-987855;
62) 2082844-001-993967;
63) 2082844-001-994441;
64) 2082844-001-995782;
65) 2082844-001-998377; Radiant infant warmer
Reason: Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration.
Root cause: Component design/selection