Hazard

Infection Risk recalls

1,010 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 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.

176–200 of 1010

SevereFDA (Devices)·Z-1522-2025·2025-04-23
Ballard Closed Suction Catheters recalled for sterility assurance failure
Avanos Medical is recalling 4,000 units of Ballard Closed Suction Catheters Model 210 used in neonatal and pediatric care due to lack of sterility assurance. The recall affects devices distributed nationwide and internationally.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 210 Software Version: N/A Product Description: Ballard Closed Suction System for Neonates/Pediatrics, 10 F, Elbow Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1526-2025·2025-04-23
Ballard Closed Suction Catheters Recalled for Lack of Sterility Assurance
Avanos Medical is recalling Ballard Closed Suction Catheters (model 2271418-5) with lot code 1555430 due to lack of sterility assurance. 1,420 units were distributed worldwide.
Product
Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Number: 2271418-5 Software Version: N/A Product Description: Ballard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1615-2025·2025-04-23
Medline Sterile Surgical Kits Recalled for Potential Packaging Seal Failure
Medline Industries recalls 671 sterile gynecological surgical kits due to potential open or weak seals on packaging breather pouches. Seal failure could compromise 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-1530-2025·2025-04-16
Hydrocolloid Bandage Recall: Potential Sterility Compromise in Multiple Models
Medline Industries recalls Wayson Hydrocolloid bandages due to potential compromise of device sterility. Approximately 364,842 units across five model numbers are affected.
Product
Wayson Hydrocolloid Models: 1) Model Number: CUR5103, DBD-BNDG,WTRPRF,HYDRCLLD,CLR,2.36X3.93", 2) Model Number: MJ18004, DBD-MEIJER,BANDAGE,HYDROCOLLOID,HEEL,OVL 3) Model Number: MJ18005, MEIJER,BANDAGE,HYDROCOLLOID,ALLPURP,10CT 4) Model Number: MJ76126V1, DBD-MEIJER,HYDROCOL
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1425-2025·2025-04-02
Lap Pack Convenience Kits Recalled for Sterility Assurance Concerns
American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.
Product
Brand Name: Banner Health Systems Product Name: Lap Pack - 170307 Model/Catalog Number: BHLP62H Software Version: N/A Product Description: Convenience Kit Component: No
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0295-2025·2025-04-02
Compounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
QuVa Pharma recalls compounded fentanyl and bupivacaine epidural injections due to lack of sterility assurance. Affected lots distributed nationwide pose potential infection risks.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1356-2025·2025-03-26
AV Fistula Kit Recall Due to Unconfirmed Sterilization Assurance
American Contract Systems Inc is recalling 90 AV Fistula kits because sterilization assurance requirements cannot be confirmed. Possible loss of functionality could delay or prolong patient treatment.
Product
AV FISTULA , Model No UTAV77T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1333-2025·2025-03-26
Medical Device HIP SCOPE Recall Due to Sterilization Assurance Failure
American Contract Systems Inc recalls HIP SCOPE orthopedic surgical kits due to inability to confirm sterilization assurance requirements were met. Unsterilized instruments could increase infection risk during surgical procedures.
Product
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1331-2025·2025-03-26
Laparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
American Contract Systems Inc. is recalling 303 Laparoscopy Packs (Models CALS41F, CALS41F-01, CALS41G) because sterilization assurance requirements could not be confirmed. Unsterilized instruments may cause infection or delayed treatment.
Product
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1357-2025·2025-03-26
General Laparoscopic Pack Recall Due to Unconfirmed Sterilization
American Contract Systems Inc is recalling 534 kits of General Laparoscopic Pack-LF surgical instruments because sterilization assurance could not be confirmed. This could result in loss of functionality and treatment delays.
Product
GENERAL LAPAROSCOPIC PACK-LF , Model No UTGL53S-06 UTGL53S-07 UTGL53S-08
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1360-2025·2025-03-26
Lumbar Spine Pack Recalled Due to Sterilization Assurance Failure
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
Product
SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1340-2025·2025-03-26
General Angio Pack Sterilization Assurance Cannot Be Confirmed
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Product
GENERAL ANGIO PACK , Model Nos LLAP75G LLAP75G-01 LLAP75G-02 LLAP75G-03
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1406-2025·2025-03-26
Cranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
American Contract Systems Inc is recalling 91 CRANI PACK cranial procedure kits because a critical component cannot be confirmed to meet sterility requirements, making them unsuitable for surgical use.
Product
CRANI PACK, Model/Catalog Number WECR41D, medical procedure kit.
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-1343-2025·2025-03-26
PICC Line Catheters Recalled for Sterilization Assurance Issues
American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.
Product
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
Category
Medical Device
Distribution
Distributed nationwide
HighCPSC·25189·2025-03-20
Woolite Delicates Detergent Recalled Due to Bacterial Contamination Risk
Reckitt is recalling approximately 16,200 bottles of Woolite Delicates detergent sold exclusively on Amazon due to potential Pseudomonas bacteria contamination. The bacteria poses a serious infection risk to people with weakened immune systems or external medical devices.
Product
Woolite Delicates detergent in 50-fluid-ounce bottles
Category
Consumer Product
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1173-2025·2025-02-26
Medline Medical Convenience Kits Recalled for Catheter Sterility Issue
Medline is recalling medical convenience kits assembled with Coloplast Foley and prostatic catheters that were recalled due to a potential sterility issue detected during testing.
Product
Medline RR-LIVER TRNS ACCESSORY PEDS, DUNJ63397; medical procedure convenience kit
Category
Medical Device
Distribution
1 state
HighFDA (Drugs)·D-0225-2025·2025-02-26
FDA Recalls Compounded Fentanyl Citrate IV Bags Due to Sterility Concerns
Fagron Compounding Services is recalling 1,330 units of fentanyl Citrate IV bags (Lot C274-000040409) distributed in Pennsylvania due to lack of sterility assurance. The product may pose a contamination risk if administered.
Product
fentaNYL Citrate In Sodium Chloride 1600mcg/100mL (16 mcg per mL) CII, Single use 100mL IV Bag, Fagron Sterile Services, 8710 E 34th St N, Wichita, KS 67726 Bar Code 71266-5060-01
Category
Drug
Distribution
1 state
HighFDA (Devices)·Z-1126-2025·2025-02-19
Cardinal Health Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Approximately 973,785 units were distributed to the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1) KIT,DIEP FLAP , Catalog Number:PB23DFCM3; 2) KIT,DIEP FLAP , Catalog Number:PB23DFCM4; 3) KIT,DIEP FLAP , Catalog Number:PB23DFCM5; 4) KIT,DIEP FLAP , Catalog Number:PB23DFCM6; 5)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2025·2025-02-19
Cardinal Health Presource surgical kits recalled for endotoxin contamination risk
Cardinal Health is recalling Presource Kits for potential endotoxin contamination in non-sterile surgical strips and patties. These surgical components could pose infection risks if used in procedures.
Product
Cardinal Health Presource Kits: 1) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP11; 2) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP12 3) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP13 4) CHI STD SPINE OPTION 1, Catalog Number:CHIP99SP1E 5) CHI STD SPINE OPTION 2, Catalog
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1098-2025·2025-02-12
Surgical sutures recalled for potential sterility breach
Ethicon is recalling ETHIBOND EXCEL Polyester Sutures due to open packaging seals that could compromise sterility and allow pathogen contamination. No illnesses have been reported.
Product
ETHIBOND EXCEL Polyester Suture, REF: 6664H, X425H, X872H, EH7491H. Not sold in US
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1097-2025·2025-02-12
PERMA-HAND Silk Sutures Recalled for Packaging Sterility Breach
Ethicon is recalling PERMA-HAND Silk Sutures that may have open seals on packaging due to manufacturing defects, risking sterility compromise and patient infection. Approximately 78,792 units were distributed nationwide and internationally.
Product
PERMA-HAND Silk Suture, REF: K872H, W723H, 623H, K833H; Perma-hand Silk Suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurosurgical procedures.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1052-2025·2025-02-05
Karl Storz Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 221 cysto-urethroscopes because their reprocessing instructions have not been FDA-approved. Medical facilities should stop using these devices until receiving updated instructions from the manufacturer.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KA, Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1048-2025·2025-02-05
Infusion catheters recalled for missing antimicrobial heparin coating
Medline's CENTURION infusion catheters in certain lots lack the antimicrobial heparin coating they are labeled as having. The mislabeled catheters were distributed to healthcare facilities in eight states.
Product
CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7; Infusion Catheter with Antimicrobial Heparin Coating.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1049-2025·2025-02-05
Medline arterial line catheter packs recalled for missing heparin coating
Medline Industries recalls certain Sterile Infusion Catheters labeled as having antimicrobial heparin coating but lacking this coating. Affected units were either distributed directly or incorporated into medical convenience kits.
Product
MEDLINE ARTERIAL LINE PACK, REF DYNJ65208B, medical convenience kit containing Infusion Catheter with Antimicrobial Heparin Coating.
Category
Medical Device
Distribution
7 states
HighFDA (Devices)·Z-1053-2025·2025-02-05
Karl Storz Pediatric Cysto-Urethroscope Recalled for Unapproved Reprocessing Instructions
Karl Storz is recalling 185 Pediatric Cysto-Urethroscope instruments nationwide. The product instructions contain reprocessing methods that have not been reviewed or approved by the FDA for safety and effectiveness.
Product
KARL STORZ - ENDOSKOPE, REF: 27030KB, Pediatric Cysto-Urethroscope, NON STERILE, CE
Category
Medical Device
Distribution
Distributed nationwide