Open, ClassifiedPosted Aug 31, 2026·Initiated Jul 20, 2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
PATIENT ADMIN KIT
DYKA1384B
DYKA1384C
WELCOME KIT
DYKS1206D
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Patient Personal Hygiene KitDistribution: US Nationwide distribution.Recall #Z-3075-2026
Open, ClassifiedPosted Aug 31, 2026·Initiated Jul 20, 2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
LABOR CDS
CDS981762B
VAG DELIVERY ADMISSION BAG
DYKA1054F
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Labor And Delivery KitDistribution: US Nationwide distribution.Recall #Z-3076-2026
Open, ClassifiedPosted Aug 31, 2026·Initiated Jul 20, 2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
C-SECTION PREP
DYNJ32702B
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Cesarean Section TrayDistribution: US Nationwide distribution.Recall #Z-3077-2026
Open, ClassifiedPosted Aug 31, 2026·Initiated Jul 20, 2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
CATARACT PREOP KIT
DYKS1583A
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Eye TrayDistribution: US Nationwide distribution.Recall #Z-3078-2026
Open, ClassifiedPosted Aug 31, 2026·Initiated Jul 20, 2026
Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
ORTHO ASPIRATION KIT
DYKM1636A
Reason: Downstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the packaging of the applicator. Use of potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications.
Root cause: Nonconforming Material/Component
Recalling firm: Medline Industries, LPType: Orthopedic TrayDistribution: US Nationwide distribution.Recall #Z-3079-2026
Open, ClassifiedPosted Aug 28, 2026·Initiated May 19, 2026
Halyard medical convenience kits labeled as:
1) ENT, Model/Item Number (kit) ACEN89-01;
2) ENT, Model/Item Number (kit) ACEN89-02;
3) BACK PACK, Model/Item Number (kit) ALBK51-01;
4) DR DERIAN SPINE PACK SNEDHCPDH, Model/Item Number (kit) DGSP71;
5) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37;
6) BASIC PACK DR BROWN SBADHBPR16, Model/Item Number (kit) DRBS37-01;
7) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92;
8) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-01;
9) NASAL PACK SEN23SNRC3, Model/Item Number (kit) DRNS92-02;
10) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26;
11) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-01;
12) SPINE PACK DR BROWN SNEDHSPR14, Model/Item Number (kit) DRSP26-02;
13) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52;
14) SPINE DR HEYS PACK SNE23SSRCT, Model/Item Number (kit) DRSP52-01;
15) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32;
16) OHN LARYNGOSCOPY PACK SEN23BRD, Model/Item Number (kit) DULY32-01;
17) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-01;
18) MICRO FLAP PK SEN23EN14T, Model/Item Number (kit) DUMF13-02;
19) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94;
20) OHN NASAL PROCEDURE PACK SEN23, Model/Item Number (kit) DUNS94-01;
21) ORTHO POSTERIOR SPINE PK SOP23, Model/Item Number (kit) DUPS11-01;
22) ORTHO POSTERIOR SPINE PK, Model/Item Number (kit) DUPS11-02;
23) TRAM PACK SBA95TPDU6, Model/Item Number (kit) DUTM67-01;
24) SPINE PACK 176537, Model/Item Number (kit) DVSP33J;
25) LAMINECTOMY PACK, Model/Item Number (kit) EAMC108-03;
26) OMFS PACK, Model/Item Number (kit) EAMC124;
27) SINUS PACK 711866, Model/Item Number (kit) EFSN20-01;
28) KIT,SPINE, Model/Item Number (kit) EUOR004-04;
29) SPINE PACK 176556, Model/Item Number (kit) HOSP20I;
30) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-07;
31) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-08;
32) LAMINECTOMY PACK, Model/Item Number (kit) JACK401-09;
33) SPINE PACK 176476, Model/Item Number (kit) JCSP60F;
34) BACK PACK, Model/Item Number (kit) JEBK01-01;
35) PEDS SINUS PACK, Model/Item Number (kit) LBPS18-01;
36) SINUS PACK, Model/Item Number (kit) LBSN49-01;
37) ORAL SURGERY MAJOR PACK, Model/Item Number (kit) MAMC251-09;
38) SPINE PACK, Model/Item Number (kit) NAFB071-10;
39) SPINE PACK 176524, Model/Item Number (kit) OSSP27-01;
40) ORAL SURGERY HEAD, Model/Item Number (kit) SAMM029-17;
41) LAMINECTOMY PACK, Model/Item Number (kit) SELF112-03;
42) CPT FSC SINUS PACK, Model/Item Number (kit) SHAN415-01;
43) DR. DELASOTTA PLIF, Model/Item Number (kit) SHOR001-15;
44) DELASOTTA MINOR BACK, Model/Item Number (kit) SHOR005-12;
45) SPINE PACK, Model/Item Number (kit) SLCR80-01;
46) DIEP PACK, Model/Item Number (kit) SLDP19-01;
47) SPINE PACK - MAJOR, Model/Item Number (kit) SPST001-06;
48) ESS TRAY, Model/Item Number (kit) SWMR011-02;
49) SPINE PACK 176547, Model/Item Number (kit) TPSP14-01;
50) LAMINECTOMY PACK, Model/Item Number (kit) VALD009-08;
51) EENT PACK, Model/Item Number (kit) VALV225-02;
52) NEURO PACK, Model/Item Number (kit) VAST008-10;
53) SPINAL FUSION, Model/Item Number (kit) WRNM033-22.
Open, ClassifiedPosted Aug 28, 2026·Initiated May 19, 2026
1) NEURO, (kit) ACNE73-01;
2) NEURO, (kit) ACNE73-03;
3) CRANI, (kit) AKCR19-01;
4) ORTHO SPINE PACK, (kit) ARMC017;
5) BMHM NEURO PACK, (kit) BMHT016-05;
6) LUMBAR PACK, (kit) BMHT112-03;
7) NEURO LAMINECTOMY PACK, (kit) DGNE75;
8) NEURO LAMINECTOMY PACK, (kit) DGNE75-02;
9) DRAH NEURO LAMINECTOMY SNEDHDN,(kit) DRNE75;
10) DRAH NEURO LAMINECTOMY SNEDHDN, (kit) DRNE75-01;
11) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-01;
12) CRANIOSYNOSTOSIS CUSTOM SNE23C, (kit) DUCR36-02;
13) NEURO CRANIOTOMY PK SNE23C1116, (kit) DUNC42-01;
14) PEDS NEURO PACK SNE2301147, (kit) DUNE88-01;
15) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-01;
16) NEURO SPINE PACK SNE23LM110, (kit) DUSP98-02;
17) CRANI PACK 712638, (kit) EFCR86-01;
18) SPINE PACK 712040, (kit) EFSP30-01;
19) SPINE PACK 712040, (kit) EFSP30-02;
20) CRANIOTOMY TRAY, (kit) EURO009-09;
21) CRANI PACK, (kit) IHCR36-01;
22) NEURO PACK, (kit) IHNE35-01;
23) CRANIOTOMY PACK, (kit) JACK410-11;
24) BASIC NEURO PACK, (kit) MAMC275-06;
25) BASIC NEURO PACK, (kit) MAMC275-07;
26) SPINE CRANI PACK, (kit) MCSP92-01;
27) CRANIOTOMY PACK, (kit) MECP05R;
28) SPINE TRAY GLOBALMICROSURG, (kit) MEDF217-02;
29) NEURO BASIC PACK, (kit) MENE06T;
30) CRANIAL PACK - 205992, (kit) MHCP75-01;
31) NEURO PACK, (kit) MMOK007-03;
32) NEURO PACK, (kit) MMTN012-04;
33) CRANIOTOMY PACK SNECGCRM11, (kit) MSMC108-01;
34) NEURO ANT CERV LAMI ADD A PACK, (kit) NAMC413-07;
35) STRL NEURO LUMB LAMI ADD A PK, (kit) NAMC433-05;
36) NEURO CRANI ADD A PACK, (kit) NAMC434-08;
37) NEURO PACK, (kit) NWHR010-03;
38) CRANIOTOMY PACK OSBORN 176518, (kit) OSCR20-01;
39) NEURO PACK, (kit) RDLD001-14;
40) CRANI PACK, (kit) RDLD008-14;
41) NEURO LUMBAR CERVICAL PACK,(kit) SAMM031-18;
42) CRANIOTOMY PACK, (kit) SELF111-02;
43) PELHAM ACDF, (kit) SGAC31-02;
44) PELHAM ACDF, (kit) SGAC31-03;
45) PELHAM MINA SPINE, (kit) SGSP11;
46) PELHAM MINA SPINE, (kit) SGSP11-03;
47) PELHAM SPINE, (kit) SGSP44-02;
48) PELHAM SPINE, (kit) SGSP44-03;
49) SPINE, (kit) SGSP91;
50) SPINE, (kit) SGSP91-02;
51) SPINE, (kit) SGSP91-03;
52) NEURO SPINAL TRAY SHANDS JACKS, (kit) SHND416-02;
53) DR. DELASOTTA NEURO NECK, (kit) SHOR003-15;
54) CRANI PACK, (kit) SLCN72-01;
55) CRANI PACK, (kit) SLCN72-02;
56) CRANI PACK, (kit) SLCN72-03;
57) CRANI PACK - 208400, (kit) UDCP57-01;
58) NEURO TRAY-LF, (kit) UMIA104-11;
59) CRANIOTOMY PACK, (kit) USMA005;
60) CERVICAL NEURO PACK PGYBK, (kit) VAML012-07;
61) LUMBAR NEURO PACK PGYBK, (kit) VAML028-06;
62) NASAL SINUS, (kit) VAPX009-02;
63) LUMBAR LAMINECTOMY TRAY, (kit) VMCC024-14;
64) VA LUMBAR LAMINECTOMY, (kit) VMED009-05;
65) ANTERIOR CERVICAL PACK, (kit) WEAC53-01;
66) CRANI PACK, (kit) WECR41-01;
67) LUMBAR LAMINECTOMY PACK,67) LUMBAR LAMINECTOMY PACK, Model/Item Number (kit) WELL73-01;
68) LUMBAR LAMINECTOMY, (kit) WKMC114-03;
69) CRANIOTOMY PK, (kit) WKMC125-03;
70) DISKECTOMY PACK, (kit) WRNM030-21.
Open, ClassifiedPosted Aug 28, 2026·Initiated May 19, 2026
Halyard medical convenience kits labeled as:
1) A-P PACK - 205936, Model/Item Number (kit) ANAP22-01;
2) POSTERIOR PACK - 205960, Model/Item Number (kit) ANPP15-01;
3) ANEURYSM PACK, Model/Item Number (kit) BPAY14-01;
4) SPINE PACK, Model/Item Number (kit) HSLM53-01;
5) ANTERIOR CERVICAL PACK - 205988, Model/Item Number (kit) MHAC65-01;
6) SPINE PACK - 206013, Model/Item Number (kit) MHSP99-01;
7) CRANI PACK, Model/Item Number (kit) WECR41-01.
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: AVID Medical, Inc.Type: Orthopedic TrayDistribution: US Nationwide distribution in the states of AZ, CA, CO, WA, WY, TX, MI, FL, MD, UT, NC, MS, PA, MO, IA, NE, OH, IL, SD, MN, GA.Recall #Z-3046-2026
Open, ClassifiedPosted Aug 28, 2026·Initiated Jul 29, 2026
STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074;
qualitative and quantitative factor deficiency test
Reason: A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
Root cause: Under Investigation by firm
Recalling firm: Diagnostica Stago, Inc.Type: Test, Qualitative And Quantitative Factor DeficiencyDistribution: US Nationwide distribution in the states and territory of NJ, NY, NJ, VA, PA, FL, AL, GA, TN, OH, IL, MO, NE, TX, CO, UT, CA, PR.Recall #Z-3047-2026
Open, ClassifiedPosted Aug 27, 2026·Initiated Jul 20, 2026
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Root cause: Device Design
Recalling firm: GE Medical Systems Information Technologies IncType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.Recall #Z-3036-2026
Open, ClassifiedPosted Aug 27, 2026·Initiated Jul 20, 2026
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Root cause: Device Design
Recalling firm: GE Medical Systems Information Technologies IncType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.Recall #Z-3037-2026
Open, ClassifiedPosted Aug 27, 2026·Initiated Jul 20, 2026
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Root cause: Device Design
Recalling firm: GE Medical Systems Information Technologies IncType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.Recall #Z-3038-2026
Open, ClassifiedPosted Aug 27, 2026·Initiated Jul 20, 2026
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Reason: Software issue may result in a loss of patient monitoring at the Hub and Central Viewer. In addition, all alarm settings could be reset to factory defaults following the update and will not follow the alarm settings previously configured for each patient or care area.
Root cause: Device Design
Recalling firm: GE Medical Systems Information Technologies IncType: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Distribution: US: MI, NY and Australia, Czech Republic, Finland, Germany, Italy, Netherlands, Qatar, Saudi Arabia, Switzerland, United Arab Emirates, United Kingdom.Recall #Z-3039-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jun 30, 2026
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Reason: Fresenius Medical Care Renal Therapies Group, LLC (FMCRTG) has received complaints regarding flow-, no water-, or temperature-related alarms with the 2008T
BlueStar Hemodialysis machines.
Root cause: Process control
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLCType: Dialyzer, High Permeability With Or Without Sealed Dialysate SystemDistribution: US Nationwide distribution.Recall #Z-3017-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 14, 2026
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable
Driver
REF# CFBC-5502B
5.5mm GENESYs CrossFT Suture Anchor with
two, #2 (5 metric) Hi-Fi Sutures
Sterile
Reason: Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Root cause: Labeling design
Recalling firm: ConMed CorporationType: Fastener, Fixation, Biodegradable, Soft TissueDistribution: US Nationwide distribution in the state of TX.Recall #Z-3018-2026 Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) FEMORAL PACK, Medline Kit SKU DYNJ909393A;
2) FEVAR, Medline Kit SKU DYNJ910295D.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Cardiac Catheterization KitDistribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.Recall #Z-3019-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) OPEN HEART PACK, Medline Kit SKU CDS840393P;
2) OPEN HEART PACK, Medline Kit SKU CDS840393Q;
3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W;
4) VALVE CDS, Medline Kit SKU CDS981551G;
5) FEM POP, Medline Kit SKU CDS982028W;
6) PACK,OPEN HEART, Medline Kit SKU DYNJ906903F;
7) PACK,CLOSED HEART, Medline Kit SKU DYNJ906904C;
8) ENDOSCOPIC SKULL BASE, Medline Kit SKU DYNJ908362F;
9) OPEN HEART, Medline Kit SKU DYNJ910947;
10) CV, Medline Kit SKU DYNJ911488.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Cardiovascular Procedure KitDistribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.Recall #Z-3020-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as: MAJOR HEAD AND NECK PPS, Medline Kit SKU DYNJ9425991S
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Ear, Nose, And Throat Surgical TrayDistribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.Recall #Z-3021-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as:
1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U;
2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608;
3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L;
4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Laparoscopy KitDistribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.Recall #Z-3022-2026
Open, ClassifiedPosted Aug 26, 2026·Initiated Jul 10, 2026
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
Root cause: Process change control
Recalling firm: Medline Industries, LPType: Plastic Surgery And Accessories KitDistribution: US Nationwide distribution in the states of AL, CA, FL, IL, KS, LA, MA, MD, MO, MS, MT, NV, NY, OH, OK, SC, TX, WI.Recall #Z-3023-2026