Hazard

Infection Risk recalls

3,438 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,438
Critical: 25
Severe: 993
Most recent: 2026-10-14

Of the 3,438 infection risk recalls we have scored against our rubric, 25 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 993 (29%) 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 infection risk 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.

726–750 of 3438

HighFDA (Drugs)·D-0041-2023·2022-11-09
Compounded injectable medication recalled for lack of sterility assurance
Pharmacy Plus Inc. (Vital Care Compounder) is recalling compounded PAP/PHEN/PROSTAG/ATROPINE injections distributed in four states due to manufacturing conditions that cannot guarantee product sterility.
Product
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Drugs)·D-0038-2023·2022-11-09
Methylcobalamin Injection Recalled for Lack of Sterility Assurance
Pharmacy Plus, Inc. dba Vital Care Compounder is recalling 514 vials of methylcobalamin injection solution. FDA inspection found manufacturing conditions that do not assure sterility.
Product
METHYLCOBALAMIN PF 1 ML Injection Solution 5,000 MCG/ML Solution, 1 mL vials, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402
Category
Drug
Distribution
4 states
HighFDA (Devices)·Z-0090-2023·2022-10-26
ULTRASITE US04TL Extension Sets recalled for bonded joint failure risk
B. Braun is recalling ULTRASITE Extension Sets because the bonded joint has a high probability of failure during use. Device failure could cause leakage, bloodstream infections, and delays in therapy.
Product
ULTRASITE US04TL Smallbore T-Port Extension Set, Product Code 474515, 100 units per carton. to provide needle-free access on I.V. and Extension Sets
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·23022·2022-10-25
Pine-Sol Multi-Surface and All-Purpose Cleaners Recalled for Bacterial Contamination
Clorox is recalling Pine-Sol cleaners contaminated with Pseudomonas aeruginosa, a bacteria that risks serious infection in immunocompromised people or those with external medical devices. No illnesses have been reported to date.
Product
Pine-Sol® Scented Multi-Surface Cleaners in Lavender Clean®, Sparkling Wave®, and Lemon Fresh scents, CloroxPro® Pine-Sol® All Purpose Cleaners, in Lavender Clean®, Sparkling Wave®, Lemon Fresh, and Orange Energy® scents, and Clorox® Professional™ Pine-Sol® Lemon Fresh Cleaners.…
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0007-2023·2022-10-12
Zimmer G7 Acetabular System shells recalled due to packaging defect
Zimmer, Inc. is recalling certain G7 Acetabular System acetabular shells (52 MM and 60 MM) because the outer sterile package has corner walls thinner than specification, which could crack during transit and potentially lead to surgical complications or infection.
Product
G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1826-2022·2022-10-05
Bentson Wire Guide Devices Recalled for Potential Sterility Compromise
Cook Incorporated is recalling Bentson Wire Guide devices due to potential packaging defects that may compromise device sterility.
Product
Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-145 (GPN G27041)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1777-2022·2022-10-05
Collagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
Collagen Matrix Inc is recalling Collagen Dental Wound Dressing products because packaging may not be sealed, potentially compromising sterility. Affected products were distributed to medical distributors in six states.
Product
Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product was distributed under the following brand names: 1) Cytoplast RTMTAPE, 25mm x 75mm 2) GIBSON Healthcare, 25mm x 75mm 3) MaxxTape, 2.5cm x 7.5cm x 0.1cm 4) NEOTAPE, 25mm x 75mm 5) Karl…
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1827-2022·2022-10-05
Bentson Wire Guide Recalled for Packaging Defect Affecting Sterility
Cook Incorporated is recalling Bentson Wire Guide guidewires due to packaging seal failures that may compromise sterility. The recall affects over 5,500 units distributed in the U.S. and internationally.
Product
Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFB-35-80 (GPN G01315) TSFB-35-145 (GPN G00691) TSFB-35-200 (GPN G01095)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1779-2022·2022-10-05
SunMed Pulset Syringes Recalled Due to Non-Sterile Spare Needles
SunMed Holdings is recalling Pulset 3cc syringes with non-sterile spare needles that could cause skin infection or sepsis if used. The recall affects 53,560 units distributed across ten US states.
Product
Full Kit Pulset 3cc Syringe 23g x 1 Safety Tip 25u BH, REF Number 3373-91
Category
Medical Device
Distribution
10 states
HighFDA (Devices)·Z-1852-2022·2022-10-05
YelloPort Elite Laparoscopic Trocar and Adaptor Non-Sterile Recall
Surgical Innovations Ltd is recalling YelloPort Elite laparoscopic surgical instruments because devices labeled as sterile are non-sterile, posing infection risk if used in surgery.
Product
Product/Part: YelloPort Elite 12x75 Pencil Point Trocar/ET1207503; YelloPort Elite Hasson Adaptor 10mm/EA10NH. For use in laparoscopic procedures.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1853-2022·2022-10-05
YelloPort Plus 5x70 Cannula recalled: labeled sterile but non-sterile
YelloPort Plus 5x70 Cannula devices are labeled as sterile but are actually non-sterile. This mislabeling poses an infection risk for laparoscopic surgical patients.
Product
Product/Part: YelloPort Plus 5x70 Cannula + Luer/YC0507001. For use in laparoscopic procedures.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1835-2022·2022-10-05
Cook Incorporated Recalls Guidewire Due to Packaging Seal Breach
Cook Incorporated is recalling Heavy Double Flexible Tipped Wire Guide devices due to potential packaging seal breach that may compromise sterility. Affected products were distributed domestically and worldwide.
Product
Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN: THDOC-35-60-0-3 G11949 C-HDOC-18-40-0-2 G09201 C-THDOC-18-40-0-2-HTS G26925
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1758-2022·2022-09-28
BD MaxGuard Extension Set Wrong Expiration Label Poses Infection Risk
CAREFUSION is recalling 600 BD MaxGuard Extension Sets because labels list expiration year 2027 instead of 2025. Using expired products may cause leaks and infection risk.
Product
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1753-2022·2022-09-28
BD MaxGuard Extension Set Mislabeled With Wrong Expiration Date
BD MaxGuard Extension Set units have labels listing 2027 as the expiration year instead of 2025. Using expired medical devices may compromise product integrity and increase the risk of leaks and infection.
Product
BD MaxGuard Extension Set, REF: ME1069
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1757-2022·2022-09-28
BD MaxGuard Extension Sets Recalled for Mislabeled Expiration Dates
CAREFUSION is recalling 17,250 BD MaxGuard Extension Set units with labels listing incorrect expiration year 2027 instead of 2025. Using expired products could compromise device integrity and create infection risk to patients and healthcare workers.
Product
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1756-2022·2022-09-28
BD MaxGuard Administration Set Recalled for Incorrect Expiration Date Labels
BD MaxGuard Drop Administration set labels incorrectly list expiration year 2027 instead of 2025. Use of expired product risks compromised integrity, potential leaks, and patient or worker infection.
Product
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1760-2022·2022-09-28
BD MaxGuard Administration Set Recalled for Incorrect Expiration Labeling
CAREFUSION is recalling BD MaxGuard 15 Drop Administration Sets with incorrect expiration year labels (showing 2027 instead of 2025). Use of expired product may compromise integrity and risk infection.
Product
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1754-2022·2022-09-28
BD MaxGuard Extension Set Mislabeled with Wrong Expiration Year
BD MaxGuard Flow Controller Extension Set labels incorrectly list 2027 expiration instead of 2025. Use of expired product could compromise device integrity and create infection risk.
Product
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1759-2022·2022-09-28
BD MaxGuard Extension Set Recalled for Incorrect Expiration Year
CAREFUSION's BD MaxGuard Extension Set is being recalled because product labels incorrectly list expiration year 2027 instead of 2025. Using expired product may compromise integrity, potentially causing leaks and infection risk.
Product
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1752-2022·2022-09-28
BD MaxGuard Extension Set labeled with incorrect expiration year 2027
46,900 BD MaxGuard Extension Sets are labeled with expiration year 2027 but should expire in 2025. Using expired product may compromise integrity and cause leaks, risking infection.
Product
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1755-2022·2022-09-28
BD MaxGuard Flow Controller Extension Set recalled for mislabeled expiration dates
CAREFUSION is recalling BD MaxGuard Flow Controller Extension Sets because product labels show expiration year 2027 instead of 2025. Using expired sets risks product integrity failure and potential patient infection.
Product
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Category
Medical Device
Distribution
39 states
HighFDA (Devices)·Z-1766-2022·2022-09-28
HLS Set Advanced Sterility Breach Recall for Cardiac Support Equipment
Maquet Medical Systems USA is recalling HLS Set Advanced 5050 units due to a potential breach in the sterility barrier. The defect may result in compromised product sterility for this cardiac and respiratory support equipment.
Product
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1531-2022·2022-09-21
Injectable drug recalled due to lack of sterility assurance
Carolina Infusion is recalling TRI-MIX 30/2/40 Injectable because the manufacturer cannot assure the product's sterility. Non-sterile injectable drugs pose serious infection risks.
Product
TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1709-2022·2022-09-21
Roadrunner PC Wire Guide Recalled for Sterility Testing Failure
Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.
Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-1528-2022·2022-09-21
TRI-MIX 30/1/40 Injectable Recalled Due to Lack of Sterile Assurance
Carolina Infusion is recalling TRI-MIX 30/1/40 Injectable due to lack of assurance of sterility. Affected lots were distributed nationwide and pose risk of infection.
Product
TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.
Category
Drug
Distribution
Distributed nationwide