Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
MEDLINE medical procedure convenience kit labeled as:
1) TOTAL KNEE-LF, Medline kit SKU CDSOPT590T;
2) TOTAL KNEE-LF, Medline kit SKU CDSOPT590U;
3) TOTAL KNEE CDS, Medline kit SKU CDS983930J;
4) HIP CDS-LF, Medline kit SKU CDS984556L;
5) HIP CDS-LF, Medline kit SKU CDS984556M;
6) TOTAL KNEE PACK, Medline kit SKU DYNJ905162Q.
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: Orthopedic TrayDistribution: US: Mo, CO, ILRecall #Z-2765-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 16, 2026
MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android)
Reason: For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the associated alerts will not be triggered during the nighttime. This could result in missed rapid-acting insulin doses without the user s knowledge, and may lead to delayed therapy and an increased risk of hyperglycemia.
Root cause: Software design
Recalling firm: Medtronic MiniMed, Inc.Type: Calculator, Drug DoseDistribution: Worldwide - US Nationwide distribution in the states and territories of PR, OH, WA, IL, NC, PA, VA, MN, ID, CA, UT, MI, NJ, MS, SC, CO, AZ, OR, AR, MO, TX, AL, FL, NY, IN, TN, IA, WI, MA, LA, OK, GA, KS, NM, CT, KY, NH, NV, MD and the countries of Australia, Switzerland, Germany, Denmark, Spain, Finland, Iceland, Norway, Sweden.Recall #Z-2778-2026 Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116I
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2779-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
DAVINCI PROSTATE PACK
DYNJ68477L
DYNJ68477M
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2780-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
UROLOGY ROBOTIC PROCEDURE PACK
DYNJ0945779U
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2781-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
NON MB DAVINCI LITHOTOMY SM PK
DYNJT6105
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2782-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
PROSTATE ROBOTIC
DYNJ901822B
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2783-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
ROBOTIC
CDS980523M
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2784-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
RR-DAVINCI PROSTATE ACCESSORY
DYNJ63392F
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2785-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
SM-LAPAROSCOPIC PROSTATE PAC
DYNJ61206J
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Gynecological Laparoscopic KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2786-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 8, 2026
Medline convenience kits containing Bard Silastic Foley Catheters (French sizes 16, 18, 20) 5cc balloons.
KIT ROBOTICS UROLOGY PROSTATE
DYKMBNDL116G
Reason: Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter. Issue may result in the use of urinary catheters that exhibit staining on the catheter surface; raw material present in increased amounts may be harmful.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Obstetrical KitDistribution: US Nationwide distribution in the states of CA, FL, MD. PA, and TX.Recall #Z-2787-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 11, 2026
Medline medical convenience kits labeled as:
1) KIT PEDIATRIC OPEN HEART MOSES, Medline Kit SKU DYNJ910103B;
2) BASIC HEART CDS, Medline Kit SKU DYNJ910961A.
Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.Recall #Z-2788-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 11, 2026
Medline medical convenience kits labeled as:
1) SHOULDER PACK, Medline Kit SKU DYNJ39590O;
2) SHOULDER PACK, Medline Kit SKU DYNJ88566;
3) MAJOR ORTHO KIT, Medline Kit SKU DYNJ911535.
Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Root cause: Process change control
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.Recall #Z-2789-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 11, 2026
Medline medical convenience kits labeled as:
NEURO PACK, Medline Kit SKU DYNJ59397P
Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Neurological TrayDistribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.Recall #Z-2790-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated Jun 11, 2026
Medline medical convenience kits labeled as:
1) TOTAL JOINT PACK Medline Kit SKU DYNJ65065A:
2) EXTREMITY/FOOT PACK Medline Kit SKU DYNJ65066B:
3) ANTERIOR CERVICAL-SMH Medline Kit SKU DYNJ907718B:
4) LAMINECTOMY-SMH Medline Kit SKU DYNJ907732C:
5) KYPHOPLASTY Medline Kit SKU DYNJ907984C:
6) LUMBAR LAMINECTOMY Medline Kit SKU DYNJ907987D:
7) KYPHOPLASTY TRAY Medline Kit SKU DYNJ908413C:
8) CRANIOTOMY Medline Kit SKU DYNJ910626:
9) NEURO SPINE Medline Kit SKU DYNJ910639.
Reason: Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US: CT, FL, KS, OH, OR, NY, MD, MT, VA, MA.Recall #Z-2791-2026
Open, ClassifiedPosted Jul 23, 2026·Initiated May 13, 2026
SafeOp Patient Interface, REF: AIX11240, part of SafeOp 3: Neural Informatix System
Reason: Intraoperative neuromonitoring device, due to a software issue, may experience loss or interruption of triggered electromyography (tEMG) functionality during use, displaying as system faults, loss of communication between the Patient Interface and Tablet, and prompts requiring system reboot; may result in increased operative time and surgical plan change.
Root cause: Software Design Change
Recalling firm: Alphatec Spine, Inc.Type: Stimulator, Electrical, Evoked ResponseDistribution: US Nationwide distribution in the states of TX, MO, IN.Recall #Z-2793-2026 Open, ClassifiedPosted Jul 23, 2026·Initiated May 21, 2026
Flexible Hystero-Fiberscope Kits REF: 11264BBU1, 11264BBUK1, that contain expired Single Use Endoscopic Seal: GYN, REF: 26153EAU/1.
Reason: Flexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal for gynecology use, which could impact the assurance of sterility.
Root cause: Packaging change control
Recalling firm: Karl Storz EndoscopyType: Hysteroscope (And Accessories)Distribution: US Nationwide distribution in the states of FL, MA, MN, TX, OH, NY, CA, MI, LA, VA, MD, PA, GA, WI, VT.Recall #Z-2794-2026
Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 5, 2026
MEDLINE ANTERIOR HIP, Medline Kit SKU DYNJ909640G
Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: General Surgery TrayDistribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ.Recall #Z-2747-2026
Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 5, 2026
MEDLINE convenience kits labeled as:
1) C-SECTION, Medline SKU DYNJ910835;
2) C-SECTION, Medline SKU DYNJ910835A; medical convenience kits
Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Cesarean Section TrayDistribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ.Recall #Z-2748-2026
Open, ClassifiedPosted Jul 22, 2026·Initiated Jun 5, 2026
MEDLINE convenience kits labeled as:
1) TOTAL JOINT KIT, Medline Kit SKU DYKS1574A;
2) TOTAL KNEE BASIC, Medline Kit SKU DYNJ902378J;
3) TOTAL HIP, Medline Kit SKU DYNJ903492K;
4) ANTERIOR HIP, Medline Kit SKU DYNJ903493I;
5) ANTERIOR HIP, Medline Kit SKU DYNJ903493J;
6) ANTERIOR HIP, Medline Kit SKU DYNJ903493K;
7) TOTAL HIP, Medline Kit SKU DYNJ906665G;
8) TOTAL KNEE, Medline Kit SKU DYNJ906666J;
9) TOTAL HIP-LF, Medline Kit SKU DYNJ909000A;
10) TOTAL KNEE-LF, Medline Kit SKU DYNJ909002A;
11) TOTAL HIP W NAVIGATION NO SYR, Medline Kit SKU DYNJ909068B;
12) TOTAL JOINT, Medline Kit SKU DYNJ909069B;
13) TOTAL KNEE, Medline Kit SKU DYNJ909070C;
14) TOTAL KNEE W NAVIGATION NO SYR, Medline Kit SKU DYNJ909071B;
15) TOTAL KNEE W NAVIGATION, Medline Kit SKU DYNJ909071C;
16) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534;
17) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534A;
18) MHCZ TOTAL KNEE, Medline Kit SKU DYNJ909534B;
19) ANTERIOR HIP, Medline Kit SKU DYNJ909640F;
20) POSTERIOR HIP, Medline Kit SKU DYNJ909642D;
21) TOTAL KNEE, Medline Kit SKU DYNJ909643D;
22) TOTAL KNEE, Medline Kit SKU DYNJ909643F;
23) TOTAL JOINT, Medline Kit SKU DYNJ910002A;
24) TOTAL KNEE, Medline Kit SKU DYNJ910354A;
25) TOTAL HIP, Medline Kit SKU DYNJ910813;
26) ANTERIOR HIP, Medline Kit SKU DYNJ911083.
Reason: Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Braun Medical Inc. was notified by their supplier, Spectra Medical Devices, LLC of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. Huons Co, Ltd. has issued a voluntary recall of this product due to quality issues.
Root cause: Under Investigation by firm
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US: OH, CA, IL, IN, FL, SC, AZ, NJ.Recall #Z-2749-2026