Hazard

Sterility Breach recalls

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

About this hazard tag

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

76–100 of 178

HighFDA (Devices)·Z-1334-2023·2023-04-12
Medtronic XPANSE Bone Insert Recalled for Sterile Packaging Non-Conformances
Medtronic is recalling XPANSE Bone Insert products due to packaging defects that may compromise the sterile barrier. Non-sterile packaging could allow contamination before surgical implantation.
Product
Medtronic XPANSE Bone Insert: a) DBM T600106 XPANSE SMALL-C 6, REF T600106; b) DBM T600206 XPANSE MEDIUM-C 6, REF T600206; c) DBM T600209 XPANSE MEDIUM-C 9, REF T600209; d) DBM T600306 XPANSE LARGE-C 6, REF T600306; e) DBM T600309 XPANSE LARGE-C 9, REF T600309;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2023·2023-03-15
Genesis Sterilization Containers Recalled for Shelf-Life Testing Failure
Carefusion's CD5 Series Genesis surgical sterilization containers are being recalled due to failure to meet shelf-life testing requirements, resulting in a potential breach of sterility. The recall affects 5,952 devices distributed worldwide.
Product
CD5 Series of Genesis Reusable Rigid Sterilization Container Systems catalog number and product name: 1. CD5-3B, CONTAINER SHALLOW LG ENDO 3IN PERF; 2. CD5-3C, CONTAINER SHALLOW LG ENDO 3IN SOLID; 3. CD5-61B, GENESIS CONT LARGE ENDO PERF 28X11X6IN; 4. CD5-61C, GENESIS C
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2023·2023-02-22
Medline surgical convenience kits recalled for inadequate exterior sterility
Medline is recalling surgical convenience kits because the perforated bag does not maintain sterility of the kit's exterior wrapping. Only the contents inside the wrapping are sterile.
Product
Surgical convenience kits labeled as: MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1064-2023·2023-02-15
Sterile Procedural Trays Recalled Over Potential Blade Puncture of Packaging
Medline Industries is recalling sterile procedural trays because sterile blades inside could puncture the outer foil packaging, compromising sterility. The recall affects units distributed worldwide.
Product
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0939-2023·2023-01-18
HCT 6 CC Syringe Kits recalled for potential sterility breach from packaging leaks
Stradis Healthcare recalls 76,260 HCT 6 CC Syringe Kits due to potential pinhole leaks in outer packaging that may compromise sterility. The kits were distributed nationwide.
Product
HCT 6 CC SYRINGE KIT, 25/TRAY, 4 TRAYS/BAG, 5 BAGS/CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2023·2023-01-18
PHS Lacertaion Tray Sterile Kit Recall Due to Seal Leakage Risk
Stradis Healthcare recalls PHS Lacertaion Tray sterile surgical kits due to potential pinhole leaks in outer packaging near the seal that could compromise sterility. 300 units affected across 10 US states.
Product
PHS Lacertaion Tray, Sterile, 20 per case, Manufactured for Professional Hosptial Supply, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2023·2023-01-18
Fluid Filter Transfer Kit Recalled Over Potential Sterility Breaches
Stradis Healthcare is recalling approximately 1,175 Tacy Medical fluid filter transfer kits due to potential pinhole leaks in the outer bag that may compromise sterility. The kits were distributed nationwide in nine states.
Product
Tacy Medical, Inc Fluid Filter Transfer Kit, Sterile, 60 kits per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2023·2023-01-18
Henry Shein Sterile Gloves Recalled for Potential Sterility Breach
Stradis Healthcare is recalling Henry Shein sterile gloves due to pinhole leaks in outer packaging that may compromise sterility. The recall affects approximately 21,755 units distributed nationwide.
Product
Henry Shein GLOVES, packaged in the following sizes and descriptions: a. Glove 6.5 Pack, 25 Pairs, 10 packs per case; b. Glove 7.0 Pack, 25 Pairs, 10 packs per case; c. Glove 7.5 Pack, 25 Pairs, 10 packs per case; d. Glove 8.0 Pack, 25 Pairs, 10 packs per case;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0942-2023·2023-01-18
Stradis Healthcare Neonatal PICC Trays recalled for potential sterility breach
Stradis Healthcare is recalling 2,500 units of Neonatal PICC Trays due to potential pinhole leaks in the outer bag that could compromise sterility. The affected trays were distributed nationwide.
Product
Stradis Healthcare NEONATAL PICC Tray *PGBK* 20 trays per case. Manufactured by Stradis Healthcare, Distributed by Med Alliance Group
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0935-2023·2023-01-18
PICC Kit Recall: Outer Bag Pinhole Leaks May Compromise Sterility
Stradis Healthcare is recalling PICC Kits due to potential pinhole leaks in the outer bag that may compromise kit sterility. No illnesses or injuries have been reported.
Product
PICC KIT, 10/CS, ACCESS MEDICAL LABEL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2023·2023-01-18
Stradis Healthcare Recalls Sterile Port Access Tray Kits for Potential Sterility Breach
Stradis Healthcare is recalling 600 units of Tacy Medical sterile port access trays due to potential pinhole leaks in the outer packaging that could compromise sterility.
Product
Tacy Medical, Inc PORT ACCESS TRAY, Sterile, QTY 20. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0944-2023·2023-01-18
Stradis Healthcare TCTR Convenience Kit recalled for potential sterility compromise
Stradis Healthcare is recalling the TCTR Convenience Kit due to potential pinhole leaks near the seal that could compromise the kit's sterility. The recall affects 80 units distributed across ten states.
Product
Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0946-2023·2023-01-18
Tacy Medical Syringe Convenience Packs Recalled Due to Potential Sterility Loss
Tacy Medical syringe convenience packs may have pinhole leaks near the seal that compromise sterility. Affected lots 222270319 and 220834335 were distributed across 10 U.S. states.
Product
Tacy Medical, Inc Syringe Convenience Pack, IML L/L, Sterile, 60 packs per bag, 5 bags per case. Manufactured for Tracy Medical, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0943-2023·2023-01-18
McCormick Medical Distribution PORT TRAY recalled for potential sterility breaches
Stradis Healthcare is recalling McCormick Medical Distribution PORT TRAY units due to potential pinhole leaks in the outer bag that could compromise sterility. Affected units were distributed nationwide.
Product
McCormick Medical Distribution PORT TRAY, 25 trays per case. Distributed by McCormick Medical Distribution.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0940-2023·2023-01-18
Central Line Insertion Trays Recalled for Potential Sterility Breaches
Stradis Healthcare is recalling HCT Central Line Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. Approximately 1,176 units were distributed nationwide.
Product
HCT CENTRAL LINE Insertion Tray, I2 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2023·2023-01-18
Syringe Kit Recall: Potential Sterility Breach from Outer Bag Leaks
Stradis Healthcare is recalling HCT 12 CC Syringe Kits due to potential pinhole leaks in the outer bag that could compromise sterility. The recall affects 112,675 units distributed nationwide.
Product
HCT 12 CC SYRINGE KIT, 20/TRAY,5 TRAYS/BAG, 5 BAGS /CASE HCT. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2023·2023-01-18
Neonatal PICC Tray Recalled Due to Potential Sterility Breach
Vital Care Products' Neonatal PICC Tray kits may have pinhole leaks in the outer bag near the seal, potentially compromising sterility. Affected units were distributed nationwide.
Product
Vital Care Products NEONATAL PICC TRAY, Sterile, QTY 20. Manufactured for Vital Care Products, Inc.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2023·2023-01-18
HCT MAX BARRIER PICC Insertion Tray Recalled for Potential Sterility Breach
Stradis Healthcare is recalling HCT MAX BARRIER PICC Insertion Trays due to potential pinhole leaks in the outer bag that may compromise sterility. No illnesses have been reported, but affected healthcare facilities should immediately discontinue use of the affected lot.
Product
HCT MAX BARRIER PICC INSERTION TRAY 12 per case. Distributed by Health Care Technology
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0937-2023·2023-01-18
Sterile EVA Medical Bags Recalled Due to Pinhole Leak Risk
Stradis Healthcare recalls HCT 50mL sterile EVA bags due to potential pinhole leaks near the seal that could compromise sterility. Approximately 2,779 units were distributed nationwide.
Product
HCT 50mL EVA BAGS, 2 Port, Sterile, Tripple Packaged, 20 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0489-2023·2022-12-21
Surgical dental procedure kits recalled due to incomplete bag sealing
Stradis Healthcare is recalling surgical and dental procedure kits due to manufacturing defects that may result in incomplete outer bag sealing and compromised sterility.
Product
STRADIS HEALTHCARE, Surgical Pk, Item No.40649ECS, dental
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0499-2023·2022-12-21
Stradis Healthcare Safety Pins Recalled for Potential Sterility Breach
Stradis Healthcare is recalling 1-inch safety pins due to manufacturing defects that may result in incomplete sealing of outer bags, potentially compromising the sterility of medical and surgical procedure kits.
Product
STRADIS HEALTHCARE, SAFETY PINS, SMALL 1" Item No.515-001
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0491-2023·2022-12-21
Stradis Healthcare Oral Surgery Trays Recalled Due to Incomplete Sealing
Stradis Healthcare is recalling oral surgery trays due to incomplete outer bag sealing that may compromise the sterility of the surgical kit.
Product
STRADIS HEALTHCARE, pack Item No.40788SMS, oral surgery tray
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0538-2023·2022-12-21
Stradis Healthcare Thoracic Surgery Kits Recalled for Sterility Risk
Thoracic Phleb procedure kits from Stradis Healthcare are being recalled due to incomplete outer bag sealing during manufacturing, which may compromise kit sterility.
Product
STRADIS HEALTHCARE, Thoracic Phleb, Item No.682-1228,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0545-2023·2022-12-21
Stradis Healthcare Vein RF Pack surgical trays recalled for incomplete outer bag seal
Stradis Healthcare is recalling 400 units of Vein RF Pack surgical trays due to manufacturing defects that may result in incomplete outer bag sealing, potentially compromising sterility.
Product
STRADIS HEALTHCARE, Vein RF Pack, Item No.682-1942NL1,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0497-2023·2022-12-21
Dental Surgical Pack Recalled Due to Incomplete Sterile Seal
Stradis Medical is recalling a dental surgical pack because the outer bag may be incompletely sealed, potentially compromising sterility. Affected units should not be used.
Product
Surgical room, DENTAL SURGICAL PACK, Item No.41236SDSP
Category
Medical Device
Distribution
Distributed nationwide