Hazard

Infection Risk recalls

3,429 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total: 3,429
Critical: 25
Severe: 988
Most recent: 2026-09-03

Of the 3,429 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 988 (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.

576–600 of 3429

HighFDA (Devices)·Z-2303-2023·2023-08-09
Medline procedural kits recalled for ultrasound gel sterility defect
Medline recalls 100,549 procedural kits because the sterile ultrasound gel component may not meet sterility specifications. No illnesses or injuries have been reported.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. VASCULAR PACK, Model Number: DYNJ22350K, DYNJ22350L, DYNJ22676J, DYNJ23445F, DYNJ31902L, DYNJ31902M, DYNJ39432I, DYNJ39432J, DYNJ39432K, DYNJ41625B, DYNJ46246A, DYN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2317-2023·2023-08-09
Medline Procedural Kits Recalled for Ultrasound Gel Sterility Defect
Medline Industries recalled 11,436 procedural kits with Turkuaz ultrasound gel that may not meet sterility specifications. The affected kits were distributed worldwide from April 2020 to April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031; b. BREAST, Model Number: DYNJ904598B; c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2301-2023·2023-08-09
Medline Procedural Kits Recalled Due to Potential Sterility Specification Failure
Medline is recalling 41,123 procedural kits containing ultrasound gel that may fail to meet sterility specifications. The kits were distributed to healthcare facilities worldwide between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ELECTROPHYSIOLOGY PACK-LF, Model Number: DYNJ0842825D; b. EMANUEL EP TRAY, Model Number: DYNJ49933I, DYNJ49933J; c. ENDO LASER ABLATION PK-LF, Model Number: DYN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2292-2023·2023-08-09
Medline procedural kits may contain non-sterile ultrasound gel
Medline is recalling 4,900 sterile procedural kits used for arterial line insertion because the ultrasound gel component may not meet sterility specifications.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAINE, Model Number: DT22570; c. ARTERIAL BUNDLE NO CATHETER, Model Number: ART
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2323-2023·2023-08-09
Medline Procedural Kits with Turkuaz Ultrasound Gel May Not Meet Sterility Requirements
Medline is recalling 218,163 sterile procedural kits containing Turkuaz Ultrasound Gel that may not meet sterility specifications. Kits distributed April 2020-April 2023 are used in invasive medical procedures.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, Model Number: ART920; c. CENTRAL LINE INSERTION TRAY, Model Number: DT19810;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2332-2023·2023-08-09
Medline Recalls Procedural Kits Over Sterility Specification Failure
Medline Industries is recalling 9,319 procedural kits worldwide because the labeled sterile ultrasound gel component may not meet sterility specifications. The affected kits were distributed between April 2020 and April 2023.
Product
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. FETAL INTERVENTION, Model Number: DYNJ66041A, DYNJ66041B; b. FETAL INTERVENTION PACK, Model Number: DYNJ62319A, DYNJ62319B; c. ULTRASOUND PIV KIT, Model N
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2242-2023·2023-08-02
Hernia repair mesh balloon may not inflate during surgery
Davol Ventralight ST hernia repair mesh balloons may fail to inflate during surgery, potentially causing inadequate mesh placement, infection, and procedure delays.
Product
Ventralight ST 4.5" Circle with Echo PS- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0937-2023·2023-08-02
Oxacillin for Injection Recalled Nationwide for Lack of Sterility Assurance
Sagent Pharmaceuticals is recalling Oxacillin for Injection due to lack of assurance of sterility. The product was distributed to healthcare facilities nationwide.
Product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0936-2023·2023-08-02
Oxacillin for Injection recalled nationwide due to sterility concerns
Sagent Pharmaceuticals is recalling Oxacillin for Injection USP due to lack of sterility assurance. The recall affects multiple lots distributed nationwide.
Product
Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2243-2023·2023-08-02
Ventral Hernia Mesh Balloon May Fail to Inflate During Surgery
A surgical mesh implant used in ventral hernia repair may fail to inflate properly during the procedure, potentially causing inadequate placement and infection risk. The manufacturer is recalling 169 units worldwide.
Product
Ventralight ST w Echo PS 4.5" Circle A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955450G (EU on
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2241-2023·2023-08-02
Hernia repair implant balloon may not inflate as intended
Davol's Ventralight ST hernia repair implant balloon may fail to inflate properly during laparoscopic surgery. This could result in procedure delay, inadequate mesh placement, and risk of infection.
Product
Ventralight ST 4" x 6" Ellipse with Echo PS Catalog Number: 5955460
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2191-2023·2023-07-26
Medline Ultrasound Probe Covers Recalled for Inadequate Sterility Barriers
Medline is recalling ultrasound probe cover kits used in diagnostic procedures because inadequate barriers at the seams may allow bacterial contamination. The recall affects 19,940 units distributed worldwide.
Product
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CRANIOTOMY CDS-1, Model Number CDS982889I; b) JOINT INJECTION TRAY, Model Number DYNDH1722; c) LOWER EXTREMITY PACK-LF, Model Number DYNJ0604434X; d) ARTHROSCOPY PACK, Model Number D
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2207-2023·2023-07-26
Medtronic Durepair Dura Matrix Recalled Due to Endotoxin Contamination
Medtronic is recalling Durepair Dura Regeneration Matrix surgical implants worldwide due to potential endotoxin contamination that may cause inflammation similar to infection.
Product
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 6
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2136-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile in Ophthalmic Kits
Medline Industries is recalling 1,500 units of non-sterile PVP solution mislabeled as sterile in ophthalmic and eye surgical kits. Users may unknowingly apply non-sterile solution in eye procedures, risking infection.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) OCULOPLASTY PACK, Model Number DYNJ64572A; b) EYE PACK, Model Number VAL050EEPKB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2131-2023·2023-07-19
Medline PVP solution mislabeled as sterile when non-sterile
Medline Industries is recalling batches of non-sterile PVP solution that were incorrectly labeled as sterile, creating risk of inadvertent use in sterile medical settings.
Product
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2134-2023·2023-07-19
Medline Non-Sterile PVP Solution Mislabeled as Sterile
Medline Industries is recalling 128 units of non-sterile PVP solution incorrectly labeled as sterile. Using a non-sterile product in sterile contexts could create infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2137-2023·2023-07-19
Medline Non-Sterile PVP Surgical Solution Kits Mislabeled as Sterile
Medline is recalling 4,500 surgical kits because the non-sterile PVP solution inside was mislabeled as sterile. Using the mislabeled product in sterile surgical procedures could introduce non-sterile materials into surgical fields.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: a) TOTAL JOINT, Model Number CDS985555S; b) TOTAL KNEE, Model Number CDS985566Q; c) MAJOR ORTHO-LF, Model Number DYNJ0949139I; d) BSHR TOTAL KNEE-LF, Model Number DYNJ24525K; e) BSHR TOTAL HIP-LF, Model Number DYNJ24
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2135-2023·2023-07-19
Medline Non-Sterile PVP Solution Incorrectly Labeled as Sterile
Medline is recalling Non-Sterile PVP Solution Hystero Pack kits due to mislabeling: affected lots labeled as 'Sterile' when actually 'Non-Sterile'. Using non-sterile solution in sterile gynecological procedures creates infection risk.
Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2073-2023·2023-07-12
SurgiMend MP Collagen Matrix Recalled for Endotoxin Testing Issues
TEI Biosciences recalled approximately 3,992 units of SurgiMend MP surgical implants nationwide due to issues with endotoxin testing procedures that may have resulted in unreliable test results.
Product
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, and 25x40 cm.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2090-2023·2023-07-12
Custom Medical Procedure Packs Recalled for Compromised Package Seals
DeRoyal Industries is recalling 306 custom medical procedure packs because the outer package seals could be open or compromised, affecting the sterility of the contents. Affected packs were distributed nationwide.
Product
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1982-2023·2023-06-28
Medline TheraHoney Gel Wound Dressing Recalled for Sterilization Failure
Medline is recalling 851,328 units of TheraHoney Gel wound dressing due to inadequate sterilization. The manufacturer failed to augment the sterilization dose after an audit failure, violating ISO 11137 standards.
Product
MEDLINE THERAHONEY GEL, 100% LEPTOSPERMUM SCOPARIUM HONEY, a) REF MNK0005, b) REF MNK0015 wound gel
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1639-2023·2023-06-07
Maquet QUADROX-i Adult Oxygenator recalled for packaging damage compromising sterile barrier
Maquet Medical Systems is recalling QUADROX-i Adult Oxygenators due to potential packaging damage that may compromise sterile barriers, risking infection during cardiopulmonary bypass surgery.
Product
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1643-2023·2023-06-07
Maquet QUADROX-iR Cardiopulmonary Bypass Device Recalled for Packaging Damage
Maquet Medical Systems USA is recalling QUADROX-iR cardiopulmonary bypass devices due to damaged packaging that may compromise sterility. This could result in infection, sepsis, or ischemia.
Product
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA 701067880 Adult with filter, with BIOLINE Coating HMO 5
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0648-2023·2023-05-31
Microplegia injectable recalled for lack of sterility assurance
Central Admixture Pharmacy Services recalls Microplegia injectable solution due to FDA concerns about sterility assurance. The product was distributed nationwide across the United States.
Product
Microplegia (MSA/MSG 0.92 Molar) packaged in 125 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0001-1.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0674-2023·2023-05-31
Cardioplegia Solution Recalled Due to Sterility Assurance Concerns
Central Admixture Pharmacy Services recalls 208 bags of Cardioplegia Solution nationwide due to sterility assurance concerns identified during an FDA inspection.
Product
Cardioplegia Solution, Modified St Thomas Formula, low potassium, 70 mEq K, packaged in 1000 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., Lehigh Valley, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-0210-1.
Category
Drug
Distribution
Distributed nationwide