Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2809-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78222
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2810-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 24, 2026
EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 78322
Reason: Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.
Root cause: Under Investigation by firm
Recalling firm: Medtronic Perfusion SystemsType: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary BypassDistribution: Worldwide - US Nationwide distribution.Recall #Z-2811-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Spinal Epidural Anesthesia KitDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2812-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;
2) Single Shot Epidural Tray - RX, Part Number AMS11296A;
3) Nerve Block Tray - RX, Part Number AMS11314A;
4) Epidural Tray - RX, Part Number AMS11910A;
5) Nerve Block Tray - RX, Part Number AMS12171;
6) Single Shot Epidural Tray - RX, Part Number AMS12219A;
7) Universal Block Tray - RX, Part Number AMS12381B.
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Epidural Anesthesia KitDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2813-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Nerve Block Tray - RX, Part Number AMS13975A;
2) Universal Block Tray- RX, Part Number AMS2009;
3) Nerve Block Tray - RX, Part Number AMS3224.
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Nerve Block TrayDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2814-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Angiography/Angioplasty KitDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2815-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2816-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Neurological TrayDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2817-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Loop Recorder Pack 2 -RX, Part Number AMS10164;
2) NY Tray - RX, Part Number AMS10276A;
3) NYC Tray - RX, Part Number AMS10281B;
4) Vein Pack - RX, Part Number AMS11398C;
5) Radiology Tray-RX, Part Number AMS1217A;
6) Custom Pack - RX, Part Number AMS12757B;
7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700;
8) Arthrogram Tray - RX, Part Number AMS13755A;
9) Myelogram Tray - RX, Part Number AMS14805A;
10) Arthrogram Tray - RX, Part Number AMS15071A;
11) Vein Pack - RX, Part Number AMS15270;
12) Myelogram Tray - RX, Part Number AMS15298;
13) Loop Pack - RX, Part Number AMS15643;
14) Basic Biopsy Tray - RX, Part Number AMS15662A;
15) Pain Pack -RX, Part Number AMS17021;
16) Pain Tray -RX, Part Number AMS17817;
17) Vasectomy Pack - RX, Part Number AMS18226;
18) Arthrogram Tray- RX, Part Number AMS2886(A;
19) Custom Pack - RX, Part Number AMS3081C;
20) Basic Procedure Pack - RX, Part Number AMS5497;
21) Basic Pack - RX, Part Number AMS8130C;
22) Supply Kit - RX, Part Number AMS9521A;
23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2818-2026
Open, ClassifiedPosted Jul 27, 2026·Initiated Jun 17, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Reason: Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Port Introducer KitDistribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.Recall #Z-2819-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Feb 29, 2024
Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock
REF:120031, Model version 3
Reason: This recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds 50 mm, which may cause the user to fall from the wheelchair or the wheelchair to tip over,
Root cause: Process control
Recalling firm: Permobil IncType: Wheelchair, PoweredDistribution: Worldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CAN.Recall #Z-2795-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 8, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Part Number AMS10411B;
2) ENT Pack, Part Number AMS10411C;
3) Rhinoplasty Pack, Part Number AMS11963A;
4) Spine Pack, Part Number AMS12636C;
5) Lumbar Lami Pack, Part Number AMS12731;
6) Septoplasty Pack, Part Number AMS13150;
7) Septoplasty Pack, Part Number AMS13150A;
8) Septoplasty Pack, Part Number AMS13150B;
9) Rhinoplasty Pack, Part Number AMS14496A;
10) Rhinoplasty Pack, Part Number AMS14496B;
11) Rhinoplasty Pack, Part Number AMS14496C;
12) Laryngoscopy Pack, Part Number AMS14736;
13) Nasal and Sinus Pack, Part Number AMS16417;
14) Major Pack, Part Number AMS16586;
15) Major Pack, Part Number AMS16586A;
16) Nasal and Sinus Pack, Part Number AMS7619A;
17) Sinus Pack, Part Number AMS7819A.
Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: General Surgery TrayDistribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.Recall #Z-2799-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 8, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) ENT Pack, Pack Number AMS12206;
2) ENT Pack, Pack Number AMS15517;
3) ENT Facial Pack, Pack Number AMS15863A.
Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.Recall #Z-2800-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 8, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Neuro Pack, Pack Number AMS12195C;
2) Neuro Pack, Pack Number AMS12195D;
3) Neuro Pack, Pack Number AMS12307;
4) Neuro Spine Pack, Pack Number AMS16313;
5) Lami Kukkar Pack, Pack Number AMS17958;
6) Neuro Pack, Pack Number AMS6452B;
7) Neuro Lami Pack, Pack Number AMS9427C.
Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Neurological TrayDistribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.Recall #Z-2801-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 8, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:
1) Laminectomy Pack, Pack Number AMS13574A;
2) ACDF/Fusion Pack, Pack Number AMS14710B;
3) Spine Pack, Pack Number AMS14991A;
4) Spine Pack, Pack Number AMS14991B;
5) Spinal Pack, Pack Number AMS16278;
6) Spine Pack, Pack Number AMS16499;
7) Spine Pack, Pack Number AMS16709;
8) Lumbar Spine Pack, Pack Number AMS17336;
9) Laminectomy Pack, Pack Number AMS17945;
10) Anterior Cervical Pack, Pack Number AMS17946;
11) Spine Pack, Pack Number AMS3150F;
12) Spine Pack, Pack Number AMS3150G;
13) Spine Pack, Pack Number AMS5451D;
14) ENT Pack, Pack Number AMS9771.
Reason: The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Root cause: Material/Component Contamination
Recalling firm: Windstone Medical Packaging, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.Recall #Z-2802-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 15, 2026
L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463
Reason: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Root cause: Device Design
Recalling firm: Argon Medical Devices, IncType: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysDistribution: US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA.
OUS: MYS, CAN, SAURecall #Z-2803-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 15, 2026
L-Cath Midline S/L Catheter 20ga (3F) 1mm x 20cm, REF: 384620
Reason: Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
Root cause: Device Design
Recalling firm: Argon Medical Devices, IncType: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 DaysDistribution: US: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA.
OUS: MYS, CAN, SAURecall #Z-2804-2026
Open, ClassifiedPosted Jul 24, 2026·Initiated Jun 19, 2025
M5 Corpus Power Wheelchair REF,120032
Reason: This recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive under restricted conditions, and may create an unstable condition in certain circumstances.
Root cause: Process design
Recalling firm: Permobil IncType: Wheelchair, PoweredDistribution: Worldwide - US: Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KY, ME, MI, MN, MO, MS, MT, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV, WY and the country of CANADA.Recall #Z-2805-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
MEDLINE medical procedure convenience kit labeled as: HIP CDS-LF, Medline kit SKU CDS984556N
Reason: The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that could result in drug ineffectiveness.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US: Mo, CO, ILRecall #Z-2764-2026