Hazard

Seal Integrity recalls

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

What the numbers show

Total: 15
Critical: 0
Severe: 0
Most recent: 2025-04-23

Of the 15 seal integrity 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.

Which agencies issued them

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all seal integrity 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.

1–15 of 15

HighFDA (Devices)·Z-1586-2025·2025-04-23
Medline Intubation Tray Convenience Kits Recalled for Weak Breather Pouch Seals
Medline Industries is recalling select Intubation Tray convenience kits (Model MNS10395, Lot 24KBI045) due to potential open or weak seals on breather pouches used for packaging. Weak seals may compromise product sterility.
Product
Medline Convenience kits used for various procedures: 1) INTUBATION TRAY, Model Number: MNS10395;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1600-2025·2025-04-23
Medline sterile surgical convenience kits with potentially weak seals
Medline Industries is recalling 33 models of sterile surgical convenience kits due to potential open or weak seals on breather pouches used for packaging. The defect may compromise sterility of the kits.
Product
Medline Convenience kits used for various procedures: 1) OCULOPLASTIC PICK PACK, Model Number: DYNJ43914B; 2) PLASTIC PACK, Model Number: DYNJ65109; 3) PLASTIC PROCEDURE PACK, Model Number: DYNJ34160D; 4) MINOR BREAST SJHC-LF, Model Number: DYNJ84991; 5) PLASTIC PACK, Mo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0145-2025·2024-10-30
Smiths Medical Y-Piece Airway Connector Recalled Due to Sterile Packaging Integrity Uncertainty
Smiths Medical ASD Inc. is recalling its Portex Y-Piece 15MM airway connector (9,133 units, worldwide) due to uncertainty in the sterile packaging seal integrity.
Product
smiths medical portex, Y' PIECE 15MM, REF 100/276/000
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0172-2025·2024-10-30
Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
Product
Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2183-2023·2023-07-26
Medline Ultrasound Probe Cover Kits Recalled for Seam Defects
Medline is recalling ultrasound probe cover kits containing sterile ultrasound gel due to an inadequate seam barrier. The defect may compromise sterility during diagnostic ultrasound procedures.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) IV SECUREMENT KIT, Model Number DYNDV2407A; b) USG IV START KIT, Model Number DYNDV2435; c) ULTRASOUND GUIDED IV START KIT, Model Number DYNDV2518; d) VI PACK, Model Number DYNJ64871
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0161-2023·2022-11-23
Similac Total Comfort infant formula recalled for compromised seal integrity
Abbott Laboratories is recalling Similac Total Comfort 2 fl oz bottles due to compromised seal integrity that could allow spoilage. Approximately 14.5 million bottles are affected across the US and international markets.
Product
Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged as: 12 - 4 packs in a case, 48 count case
Category
Food
Distribution
50 states
HighFDA (Food)·F-0162-2023·2022-11-23
Similac Special Care infant formula recalled for compromised seal
Abbott Laboratories is recalling Similac Special Care 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Affected bottles have batch number 41861N200 with a best-by date of 06/01/23.
Product
Similac Special Care 2 fl oz reclose able plastic bottle Packaged as: 4 count carton
Category
Food
Distribution
50 states
ModerateFDA (Food)·F-0157-2023·2022-11-23
Similac 360 Total Care Infant Formula Recalled for Compromised Bottle Seals
Abbott Laboratories is recalling batches of Similac 360 Total Care and Total Care Sensitive infant formula 2 fl oz discharge kits for compromised seal integrity that could allow spoilage. The affected batch is identified by product code 39480N200 with a Best By date of 04/01/23.
Product
Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit 2 fl oz reclose able plastic bottle Packaged as: 6 count kit
Category
Food
Distribution
50 states
HighFDA (Devices)·Z-0127-2023·2022-11-02
ConvaTec Esteem+ Durahesive Plus ostomy pouches recalled for release liner defect
ConvaTec is recalling 5,284 units of Esteem+ Durahesive Plus ostomy pouches due to impaired release liner functionality. The defect may affect proper device operation for patients managing colostomy or ileostomy output.
Product
ConvaTec Esteem+ Durahesive Plus, Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 416976. For the management of stoma output following a colostomy or ileostomy procedure.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0709-2022·2022-03-09
Lacrimedics Collagen Plugs recalled for potential sterility seal compromise
Lacrimedics is recalling Collagen Plugs (models CP3, CP4, CP5) due to potential seal integrity defects in sterile pouches. The seals may contain channels that could compromise sterility and allow contamination.
Product
Collagen Plugs, CP3, 0.3mm, CP4, 0.4mm, CP5, 0.5 mm, Sterile, EO, Rx Only, CE Dry eye treatment
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2019·2019-03-06
Organon Teknika Recalls Vitek 2 Reagent Cards Due to Seal Integrity Issues
Organon Teknika Inc is recalling 129,321 cartons of Vitek 2 reagent cards worldwide due to compromised top seal integrity that may cause inaccurate test results.
Product
Vitek 2 reagent cards: a) GN ID, REF 21341, b) GP ID, REF 21342, c) ANC ID, REF 21347, d) AST-GNOR, REF 22000, e) AST-GP67, REF 22226, f) AST-P612, REF 22359, g) AST-XN01, REF 410025, h) AST-N222, REF 413083, i) AST-N223, REF 413110, j) AST-N226, REF 413143, k) AS
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-2546-2018·2018-08-01
Life Technologies Recalls Gibco RPMI 1640 Medium Due to Seal Integrity Issues
Life Technologies is recalling Lot 1930752 of Gibco RPMI 1640 Medium because compromised fill port tube seals may allow media to leak and mold to grow.
Product
Gibco RPMI 1640 Medium, Model Number 61870150. Tissue and cell culture medium.
Category
Medical Device
Distribution
11 states
ModerateFDA (Devices)·Z-1894-2018·2018-05-30
Beckman Coulter Recalls iChem VELOCITY Urine Chemistry Systems for Seal Defects
Beckman Coulter is recalling six iChem VELOCITY Automated Urine Chemistry Systems because the Strip Provider Modules were not inspected for correct seal placement and integrity during manufacture.
Product
iChem VELOCITY Automated Urine Chemistry System, Catalog #700-7176-001 and iChem VELOCITY Automated Urine Chemistry System Computerless, Catalog #700-7177-001. The iChemVELOCITY automated urine chemistry system is an in-vitro diagnostic device used to automate the urine chemi
Category
Medical Device
Distribution
4 states
ModerateFDA (Devices)·Z-0882-2017·2016-12-28
Amendia Dual Stylet Needle Recall Due to Unacceptable Packaging Seals
Amendia, Inc. is recalling 1,078 Dual Stylet Needles because packaging seals are compromised by channels or voids, potentially affecting product integrity.
Product
Dual Stylet Needle, Part Number 812-11R-15 The guide wire is passed through the cannulated handle of the Dual Stylet Needles and pressed into the bone
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0876-2016·2016-03-02
Stryker T2 Guidewire Recalled Due to Potential Packaging Seal Integrity Issues
Stryker Howmedica Osteonics Corp. is recalling T2 Guidewires because a packaging review found that the seal integrity of the pouch may be decreased.
Product
Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments.
Category
Medical Device
Distribution
Distributed nationwide