Hazard

Sterility Compromise recalls

2,228 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 2,228
Critical: 3
Severe: 255
Most recent: 2026-08-19

Of the 2,228 sterility compromise recalls we have scored against our rubric, 3 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 255 (11%) 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 sterility compromise 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.

1026–1050 of 2228

ModerateFDA (Devices)·Z-2576-2017·2017-06-21
Zimmer Biomet Recalls Sterile Hip Implants Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile hip implants because packaging design verification tests failed. The recall covers units distributed worldwide.
Product
Segmental vss bowed 19x190mm, Sterile, Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2556-2017·2017-06-21
Zimmer Biomet Recalls Sterile Femoral Intramedullary Nails Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile femoral intramedullary nails because packaging design verification tests failed. The recall affects units distributed worldwide.
Product
Fem IM Nail 16mmdx46cm, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2583-2017·2017-06-21
Zimmer Biomet Recalls Sterile Intramedullary Rods Due to Packaging Failures
Zimmer Biomet is recalling 9,867 sterile intramedullary rods and accessories due to packaging design verification test failures.
Product
Xl por st 25.5x220mm, bowed\, bowed, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2332-2017·2017-06-21
Arrow International Recalls Central Venous Catheter Kits Due to Packaging Seal Issues
Arrow International is recalling multi-lumen central venous catheterization kits because packaging may not be completely sealed, potentially compromising sterility.
Product
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0878-2017·2017-06-07
SCA Pharmaceuticals Recalls Leaking Magnesium Sulfate Injectable Bags
SCA Pharmaceuticals is recalling 40 bags of Magnesium Sulfate injectable solution due to seam leaks that compromise sterility.
Product
MAGNESIUM Sulfate added to 100 mL 0.9% Sodium Chloride injectable, 4g, Total Approximate Volume 108 mL (does not include mfg. overfill) Single Dose Container bag, Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC: 70004-0737-32
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0872-2017·2017-06-07
SCA Pharmaceuticals Recalls Fentanyl Injection Bags Due to Seam Leaks
SCA Pharmaceuticals is recalling 118 bags of fentanyl injection due to seam leaks that compromise sterility. The product was distributed nationwide in the USA.
Product
fentaNYL (as citrate) in 0.9% Sodium Chloride injectable,10 mcg per mL, Total Volume 100 mL, Single Dose Container bag, (Total fentanyl Dose 1,000 mcg/100 mL) Preservative Free, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0229-32
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2147-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2145-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section o
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2150-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-op
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2138-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2149-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm Full W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2141-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2155-2017·2017-05-31
B. Braun Recalls CytoGuard Closed Luer Connectors Due to Sterility Concerns
B. Braun is voluntarily recalling 13 lots of CytoGuard Closed Luer Connectors because some blisters may be punctured, compromising the sterility barrier.
Product
CytoGuard Closed Luer Connector, Intravenous access 2 cartons of 50 units each (100 units per case)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2143-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 7mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2148-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Sterility Concerns
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2142-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaqu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2144-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Silicone Flat Drains Due to Sterility Concerns
Cardinal Health is recalling specific lots of Jackson-Pratt Silicone Flat Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaq
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/10FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains
Cardinal Health is recalling specific lots of Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Cardiothoracic Silicone Round Drain,19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2139-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 10FR W/Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a rad
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Round Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing the risk of infection.
Product
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain i
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2132-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
Cardinal Health is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Flat Drain. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2133-2017·2017-05-31
Cardinal Health Recalls Jackson-Pratt Hemaduct Silicone Flat Drains
Cardinal Health 200, LLC is recalling Jackson-Pratt Hemaduct Silicone Flat Drains because the product seal may be compromised, potentially compromising sterility and increasing infection risk.
Product
Jackson-Pratt Hemaduct Silicone Flat Drain, 10mm, Full Ducts W/15FR Trocar. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The w
Category
Medical Device
Distribution
Distributed nationwide