Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 16, 2026
Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Skin Prep TrayDistribution: US Nationwide distribution.Recall #Z-2044-2026
Open, ClassifiedPosted Apr 30, 2026·Initiated Mar 16, 2026
Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as:
1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion);
2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A;
3. CVC DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT5565B;
4. BSI PICC DRESSING CHANGE KIT, Medline Kit SKU EBSI1172B;
5. BSI CVC DRESSING CHANGE KIT, Medline Kit SKU EBSI1171A;
6. BSI SENSITIVE SKIN DRSNG CHNGE, Medline Kit SKU EBSI1173A;
7. LVAD MANAGEMENT SYSTEM - DAILY (Centurion), Medline Kit SKU DM810;
8. WEEKLY LVAD TRAY (Centurion), Medline Kit SKU DM100;
9. DRESSING CHANGE TRAY (Centurion), Medline Kit SKU DT7340;
10. SENSITIVE SKIN LVAD TRAY (Centurion), Medline Kit SKU DM660;
11. PORT DRESSING CHANGE KIT, Medline Kit SKU EBSI1365A.
Reason: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Webcol Large Alcohol Prep Pads to be non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Dressing Change TrayDistribution: US Nationwide distribution.Recall #Z-2045-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 27, 2026
AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling, including single use indications, is maintained for each device, which may be used independently and at different times. These specific kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that were recalled as part of RES 98317 with (510(k): K140100).
Reason: Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a very high blood glucose event (> 600 mg/dL) or when there is a test strip error, which can lead to operator confusion when evaluating patients and a delay in appropriate treatment. This is a downstream recall of Trividia Health Class I, Recall Event ID 98317.
Root cause: Component design/selection
Recalling firm: North American Rescue LLC.Type: First Aid Kit With DrugDistribution: US: CA, WARecall #Z-1947-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 7, 2026
BD GasPak EZ CO2 Pouch System. Catalog Number: 260684. for microbiologic use
Reason: BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Device, Gas GeneratingDistribution: Worldwide distribution - US Nationwide and the country of Hong Kong.Recall #Z-1982-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 7, 2026
BD GasPak EZ Campy Pouch System. Catalog Number: 260685. for microbiologic use
Reason: BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems, where gas generating sachets may produce carbon dioxide levels below specification.
Root cause: Under Investigation by firm
Recalling firm: Becton Dickinson & Co.Type: Device, Gas GeneratingDistribution: Worldwide distribution - US Nationwide and the country of Hong Kong.Recall #Z-1983-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 26, 2026
Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60
For processing of clinical specimens for Mycobacterium spp. diagnosis
Reason: Neutralization Buffer may contain contaminants
Root cause: Under Investigation by firm
Recalling firm: Immuno-Mycologics, IncType: General Purpose ReagentDistribution: US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.Recall #Z-1984-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 4 CEM. Part Number: 150450104.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1985-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 5 CEM. Part Number: 150450105.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1986-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1987-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 8 CEM. Part Number: 150450108.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1988-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1989-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1990-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1991-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 7 CEM. Part Number: 150450207.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1992-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Apr 3, 2026
Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 8 CEM. Part Number: 150450208.
Reason: The external sterile packaging was found adhered to the internal sterile packaging, potentially compromising sterility.
Root cause: Under Investigation by firm
Recalling firm: DEPUY (IRELAND)Type: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/PolymerDistribution: US Nationwide distribution in the states of MN, NC, TX.Recall #Z-1993-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 27, 2026
Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.
Endosseous Dental Implant Abutments
Reason: Includes an incorrect screw seat interface.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Abutment, Implant, Dental, EndosseousDistribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.Recall #Z-1994-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 27, 2026
Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158.
Endosseous Dental Implant Abutments
Reason: Includes an incorrect screw seat interface.
Root cause: Under Investigation by firm
Recalling firm: Straumann USA LLCType: Abutment, Implant, Dental, EndosseousDistribution: US distribution to AL, AZ, FL, HI, LA, MD, OH, VA.Recall #Z-1995-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 12, 2026
iLet Bionic Pancreas, REF: BB1001
Reason: insulin pump software versions 1.4.2, and 1.4.3 issue with Dexcom Continuous
Glucose Monitoring (CGM) G7 sensor may result in delayed CGM reading then switch to non-CGM dosing, leading to only basal/requested meal doses provided, no correction doses/insulin reductions/suspensions for high/low glucose unless blood glucose entered for
sensor life or replacement. Potential health risks to users include severe hyperglycemia with and without DKA and severe hypoglycemia.
Root cause: Software change control
Recalling firm: Beta Bionics, Inc.Type: Alternate Controller Enabled Insulin Infusion PumpDistribution: US Nationwide distribution in the states of TX, PA, AL, MI, OH, FL, TN, GA.Recall #Z-1996-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 25, 2026
Heraeus, PALAMIX uno. Material Number: 66057893.
Reason: Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Root cause: Under Investigation by firm
Recalling firm: Heraeus Medical GmbH (Dental Division)Type: Mixer, Cement, For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;Recall #Z-1997-2026
Open, ClassifiedPosted Apr 29, 2026·Initiated Mar 25, 2026
Heraeus, PALAMIX duo. Material Number: 66057897.
Reason: Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lock during the mixing process. Notification is to reduce the shelf life from 3 years to 1.5 years (17 months).
Root cause: Under Investigation by firm
Recalling firm: Heraeus Medical GmbH (Dental Division)Type: Mixer, Cement, For Clinical UseDistribution: Worldwide distribution - US Nationwide and the countries of Aland Islands, Algeria, Australia, Austria, Belgium, Brazil , Chile, China, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Kosovo, Lithuania, Luxembourg, Malaysia, Malta, Mexico, Netherlands, Nigeria, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Rep. of Korea, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom, Uruguay, Utd.Arab Emir.;Recall #Z-1998-2026