Hazard

Weak Seal recalls

28 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 28
Critical: 0
Severe: 0
Most recent: 2025-04-23

Of the 28 weak seal recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all weak seal recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–25 of 28

HighFDA (Devices)·Z-1611-2025·2025-04-23
Medline Convenience Kits for Obstetrical Procedures Recalled for Weak Seals
Medline Industries is recalling 21,935 units of sterile convenience kits used for labor, delivery, and vaginal delivery procedures due to potential open or weak seals on breather pouches. The defective packaging could compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) LABOR AND DELIVERY PACK-LF, Model Number: DYNJ26971L; 2) VAGINAL DELIVERY PACK-LF, Model Number: DYNJ0378319P; 3) VUWC OB PACK, Model Number: DYNJ64017B; 4) OB PROTECTION PACK NO GAUZE, Model Number: DYNJHTLD04A; 5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1591-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling sterile convenience kits for various medical procedures due to potential open or weak seals on breather pouches used in product packaging.
Product
Medline Convenience kits used for various procedures: 1) ANGIOGRAPHY DRAPE PACK, Model Number: HCP075G; 2) ENSEMBLE CORONAROGRAPHIE-LF, Model Number: DYNJ64354A; 3) RADIOL ANGIO PACK-LF, Model Number: 0M-CP01029D; 4) ARTERIOGRAM PACK 2, Model Number: DYNJ81454B; 5) CATH
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1599-2025·2025-04-23
Medline Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling select sterile convenience kits due to a potential for open or weak seals on the breather pouches used for packaging. The affected kits are distributed nationwide and in Canada, Mexico, Panama, and the Virgin Islands.
Product
Medline Convenience kits used for various procedures: 1) T&A ENDO PACK, Model Number: DYNJ59620A; 2) TRAY ADD A CATH FOL UM MF 10ML, Model Number: DYND150200S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1590-2025·2025-04-23
Medline sterile convenience kits recalled for potentially weak packaging seals
Medline is recalling three sterile convenience kit models due to potentially open or weak seals on the breather pouches used for packaging. The affected kits are distributed worldwide, including the US, Canada, Mexico, Panama, and the Virgin Islands.
Product
Medline Convenience kits used for various procedures: 1) ANGIO CONSOLIDATED PACK, Model Number: DYNJHTCAD1; 2) ANGIOGRAPHY TRAY-LF, Model Number: DYNJ05350V; 3) ANGIOGRAPHY PACK, Model Number: DYNJ38144C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile surgical convenience kits due to potential open or weak seals on the breather pouches used for packaging. The compromised seals could affect product sterility.
Product
Medline Convenience kits used for various procedures: 1) PERI GYN PACK, Model Number: DYNJ80786; 2) D & C HYSTEROSCOPY PACK, Model Number: DYNJ21937J; 3) VAGINAL HYSTERECTOMY WRH-LF, Model Number: DYNJ41949B; 4) HYSTER/RESECTOSCOPE #78-RF, Model Number: DYNJ21824R; 5) PE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1592-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Potential Weak Seals
Medline Industries is recalling multiple sterile surgical convenience kits because purchased breather pouches used in packaging may have open or weak seals, which could compromise sterility.
Product
Medline Convenience kits used for various procedures: 1) DR. KHAN CABG ADDS PACK, Model Number: DYNJ59310D; 2) CARDIAC STERNAL PACK, Model Number: DYNJ32436A; 3) VEIN CLOSURE PACK, Model Number: DYNJ35586G; 4) ABLATION PACK-LF, Model Number: DYNJ55343B; 5) ABLATION PACK-
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1616-2025·2025-04-23
Medline Sterile Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling multiple sterile convenience kits used for obstetric and gynecological procedures due to potential weak or open seals on breather pouches, which could compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040;
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1603-2025·2025-04-23
Medline Convenience Kits Recalled for Potentially Weak Breather Pouch Seals
Medline Industries is recalling select sterile convenience kits with Model Number MNS12590 due to potential open or weak seals on breather pouches used in packaging. The affected lot is 24IBH166.
Product
Medline Convenience kits used for various procedures: 1) PRECIP TRAY, Model Number: MNS12590
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0907-2025·2025-01-22
Panther Fusion GBS Assay Kits with Weak Cartridge Seals May Produce Invalid Results
Hologic is recalling 380 Panther Fusion GBS Assay Kits due to potential weak pouch seals on the reagent cartridge. The seals may allow invalid or incorrect test results, potentially delaying necessary treatment.
Product
Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD.
Category
Medical Device
Distribution
20 states
HighFDA (Devices)·Z-2225-2024·2024-07-10
Sterile surgical kits recalled due to weak pouch seals risking contamination
Medline sterile surgical kits are being recalled nationwide due to weak seals in the Pure Pouch component that may allow sterility breach. The recall affects 12,588 units distributed across 23 states.
Product
Sterile surgical convenience kit: Medline Retrograde PK-22025203-LF, Pack #DYNJ47873L, containing a Pure Pouch with component Sterile Curved Kelly Hemostat, Reorder #66175.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2232-2024·2024-07-10
Medline Surgical Convenience Kits Recalled for Weak Seal Compromise
Medline recalled 7,673 surgical convenience kits nationwide due to weak seals in the Pure Pouch component that may compromise sterility of surgical instruments. No injuries have been reported.
Product
Non-sterile convenience kits: a. Medline CC Drawer 4 IV Circulation, Pack #ACC010254B, containing a Pure Pouch component DYND04000, O.R. Scissors S/B, 5.5 Sterile. b. Medline Code Cart Drawer 2 Adult Kit, Pack ACC010365A, containing a Pure Pouch component DYNJ04048, Kelly
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2224-2024·2024-07-10
Medline surgical convenience kits recalled for weak seal defects
Medline Industries is recalling 12,588 sterile surgical convenience kits due to weak seals on Pure Pouch components that may breach sterility. Products were distributed nationwide across 23 states.
Product
Sterile surgical convenience kits: a. Medline Cath Lab Special Procedure, Pack #00-RDF0360, containing a Pure Pouch with component Medline Reorder #DYNJ04048, Kelly Forceps/STD STR Sterile. b. Medline Angiography Pack, Pack #DYNJ26488W, containing a Pure Pouch with compo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1434-2024·2024-04-10
Medline Centurion Surgical Retractors Recalled for Potential Sterility Breach
Medline is recalling Centurion surgical retractor kits (760 units) due to a weak seal that could compromise sterility if it fails. The weakness may not be detectable by users.
Product
Centurion retractor kits labeled as: a) STERILE 6-1/2" SENN RETRACTOR (ST7185), Product Code 66795; b) STERILE RAGNELL RETRACTOR (RR602), Product Code 67525; c) ST. SENN RETRACTOR 3 PRG BLUNT (ST7085), Product Code 37535
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2024·2024-04-10
Medline Centurion surgical kits recalled due to weak seal
Medline Industries is recalling Centurion manual surgical kits because they may have weak seals that could compromise product sterility. The defect may not be noticeable to users before the kits are used.
Product
Centurion manual surgical kits labeled as: a) STERILE ALLIS TISS FCP 10", Product Code I68905; b) VAGINAL REPAIR KIT, Product Code MNS11505; c) PTCA ADD-ON KIT, Product Code MNS11545; d) INSTRUMENT SET, Product Code SUT21355
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1447-2024·2024-04-10
Centurion PICC Line Securement Kit Recalled for Weak Seal
MEDLINE is recalling the Centurion PICC Line Securement Kit because its seal may be weak, potentially allowing sterility breach. Users may not be able to detect the weakness.
Product
Centurion PICC LINE SECUREMENT KIT, Product Code IVS565
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2024·2024-04-10
Suture Removal and Staple Remover Kits Recalled for Weak Seal
Medline Industries is recalling suture removal trays and staple remover kits due to weak seals that may compromise product sterility. Approximately 23,290 units were distributed in the US, Panama, and Canada.
Product
Centurion manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code TRI55405; b) SUTURE REMOVAL SET, Product Code 60265 MEDLINE manual surgical kits labeled as: a) SUTURE REMOVAL TRAY, Product Code 60280; b) SUTURE REMOVAL TRAY, Product Code 86125; c) SUT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2024·2024-04-10
Sterile Rubber Band Recall for Weak Seal Risk
Medline Industries, LP is recalling Centurion STERILE #16 rubber bands because the package seal may be weak, potentially compromising product sterility. The defect may not be visible to users before opening.
Product
Centurion STERILE #16 RUBBER BAND, Product Code EB16
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1453-2024·2024-04-10
Medline Swabsticks PVP Product Recalled for Weak Seal Risk
Medline Industries is recalling Swabsticks PVP swabs (2,458 units) due to weak seals that may compromise sterility. The defect may not be visible to users.
Product
MEDLINE SWABSTICKS PVP 3 PK, Product Code DYNDA2724
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2024·2024-04-10
Medline Centurion surgical scissors recalled due to weak seals
Medline Industries is recalling Centurion surgical scissors due to potentially weak seals that may compromise sterility. Users cannot reliably detect the defect, creating risk if compromised instruments are used in surgery.
Product
Centurion manual surgical kits labeled as: a) STERILE 4-1/2" S/S SCISSOR (SS5031), Product Code 65145; b) STERILE S/B SCISSOR 4-1/2" (I142), Product Code 65940; c) STERILE S/B SCISSOR 5-1/2" (I140), Product Code 65945; d) STERILE CURV IRIS SCISSOR (IC164), Product Code 66
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2024·2024-04-10
Centurion Sterile Trach Brush Recalled Due to Weak Seal
Medline Industries is recalling 1700 Centurion Sterile Trach Brush devices due to a potential weak seal that may breach product sterility if the seal fails. The defect may not be obvious to users.
Product
Centurion STERILE TRACH BRUSH, Product Code 6225ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1441-2024·2024-04-10
Centurion Surgical Instrument Kits Recalled for Potentially Weak Seals
Medline is recalling Centurion manual surgical kits with potentially weak seals that may result in a breach of sterility if the seal fails. The weak seal may not be detectable by all users.
Product
Centurion manual surgical kits labeled as: a) STERILE TUBE OCCLUDING FORCEP (TO8256), Product Code 66225; b) ST. KELLY HEMO W/TIPS (SK8039), Product Code 66565; c) STERILE BUTTERFLY PROBE (P837), Product Code 66810; d) STERILE PROBE (PR5), Product Code 66900; e) STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2024·2024-04-10
Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2024·2024-04-10
Medline Centurion Manual Surgical Kits Recalled for Weak Seal Risk
Medline Industries is recalling 1700 units of Centurion Manual surgical kits due to potential weak seals that could compromise sterility. The weak seal may not be detectable by users.
Product
Centurion Manual surgical kits labeled as: a) 15ML SAMPLING TUBE WITH CAP, Product Code 15MLVLCP; b) STERILE 9X12 RECLOSABLE BAG, Product Code MG912ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2024·2024-04-10
Centurion umbilical cord clamp cutter recalled for potential sterility breach
Medline's Centurion umbilical cord clamp cutters may have weak seals that could compromise sterility. The defect may not be detectable during normal inspection.
Product
Centurion DISP.UMBILICAL CORD CLAMP CUTTER(CTR300), Product Code 67335
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1455-2024·2024-04-10
Medline Alcohol Swabsticks Recalled for Weak Seal Compromising Sterility
Medline is recalling alcohol swabsticks that may have weak seals potentially compromising product sterility. The defect may not be visible to users.
Product
MEDLINE SWABSTICKS ALCOHOL 3PK, Product code DYNDA2723
Category
Medical Device
Distribution
Distributed nationwide