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.

2701–2725 of 3438

HighFDA (Devices)·Z-0087-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Surgical Kits Due to Sterility Concerns
Resource Optimization & Innovation LLC is recalling 68 sterile surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800091001, Sterile, LD0692A - C Section - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0096-2016·2015-10-14
FDA Recalls 924 Sterile Lap Chole Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 924 sterile surgical kits because equipment glove components may contain splits or holes that compromise sterility.
Product
regard Item Number: 800528001, Sterile, GS0612A - Lap Chole Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0035-2016·2015-10-14
Resource Optimization & Innovation Recalls 288 Sterile Vascular Surgical Kits
Resource Optimization & Innovation LLC is recalling 288 sterile vascular surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800413, Sterile, CV0482 - Vascular Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0066-2016·2015-10-14
FDA Recalls 448 Sterile Laparoscopic Cholecystectomy Surgical Kits
Resource Optimization & Innovation LLC is recalling 448 sterile surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800560, Sterile, GS0649 - Lap Chole - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0088-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Orthopedic Surgical Kits
Resource Optimization & Innovation LLC is recalling 1,476 sterile orthopedic surgical kits because the equipment glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 800407001, Sterile, OR0476A - Ortho Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0034-2016·2015-10-14
FDA Recalls Sterile Neuro Surgical Kits Due to Sterility Compromise
Resource Optimization & Innovation LLC is recalling 904 sterile neuro surgical kits because equipment glove components may have splits or holes that compromise sterility.
Product
regard Item Number: 800411, Sterile, NU0480 - Neuro Pk - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-0083-2016·2015-10-14
Resource Optimization & Innovation Recalls Sterile Total Hip Surgical Kits
Resource Optimization & Innovation LLC is recalling 24 sterile total hip surgical kits because a glove component may have splits or holes that compromise sterility.
Product
regard Item Number: 880330, Sterile, OR0761 - Total Hip - surgical kit containing cover light handle soft, RX. The responsible firm on the label is ROi, LLC, St. Louis, MO. Custom procedure tray contains surgical instruments and accessories intended for use during a surgical…
Category
Medical Device
Distribution
3 states
SevereFDA (Devices)·Z-2825-2015·2015-10-07
Arrow Kits with Medtronic Syringes Recalled for Compromised Sterility
Arrow International Inc. is recalling Arrow Kits containing Medtronic Covidien 0.9% Sodium Chloride Flush Syringes due to compromised sterility of the outer barrel.
Product
Arrow Kits with Medtronic Covidien 0.9% Sodium Chloride Flush Syringes
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2807-2015·2015-09-30
Olympus TJF-Q180V Duodenoscope Recall Issued for Revised Reprocessing Procedures
Olympus America Inc. is recalling 6,109 TJF-Q180V duodenoscopes to implement new cleaning and disinfection procedures.
Product
EVIS EXERA II Duodenovideoscope OLYMPUS TJF TypeQ180V. This instrument has been designed to be used with an Olympus video system center, light source, documentation equipment, monitors, EndoTherapy accessories (such as a biopsy forceps), and other ancillary equipment for…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1679-2015·2015-09-23
FDA Recalls Compounded Intrathecal Pain Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because FDA inspections found violations that may have compromised the product's sterility.
Product
Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1687-2015·2015-09-23
Compounding Pharmacy Recalls LIPO-Tropic Injectable Due to Sterility Concerns
The Compounding Pharmacy of America is recalling LIPO-Tropic Injectable vials because FDA inspections found violations that may affect sterility.
Product
LIPO-Tropic Injectable, Multi-Dose Vial, Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2772-2015·2015-09-23
Stryker Orthobiologics Recalls Aliquot Delivery Kits Due to Packaging Defects
Stryker Orthobiologics is recalling 9,805 Aliquot Delivery Kits because two instances of holes were found in the sterile packaging, which could compromise sterility.
Product
Aliquot Delivery Kit (Syringe and Plunger); for use in open and percutaneous procedures to facilitate placement of bone cement in weakened or diminished bone
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-1428-2015·2015-09-16
PharMEDium Recalls Ropivacaine Cassettes Due to Sterility Concerns
PharMEDium Services is recalling 120 cassettes of Ropivacaine HCl 0.2% due to a reported sterility failure. The affected units were distributed to Virginia, Illinois, Pennsylvania, and Idaho.
Product
Ropivacaine HCl 0.2% in 100 mL total volume in a 100 mL Yellow Cassette Res. Flowstop in Sodium Chloride 0.9%, Rx Only, PharMEDium Services, LLC, 6100 Global Drive, Memphis, TN 38141, NDC 61553-834-48
Category
Drug
Distribution
4 states
SevereFDA (Devices)·Z-2697-2015·2015-09-09
Customed O.B. Pack Hospital 3/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 147 units of O.B. Pack Hospital 3/CS in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
O.B. PACK HOSPITAL 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
SevereFDA (Devices)·Z-2536-2015·2015-09-09
MAHURKAR Acute Dialysis Catheters Recalled for Potential Sterility Compromise
FDA is recalling MAHURKAR 12Fr Acute Dialysis Catheters due to a potential compromise in sterility.
Product
MAHURKAR"* 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20cm, Curved Extensions, PASS Tray Item Code: 8888103003HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2534-2015·2015-09-09
Mahurkar Elite Acute Triple Lumen Catheter Tray Recalled for Sterility Concerns
Covidien LLC is recalling 171 kits of Mahurkar Elite Acute Triple Lumen Catheter Trays because sterility may be compromised.
Product
Mahurkar Elite Acute Triple Lumen Catheter Tray, Curved Extensions with IC* Safety Components, 12.5 Fr x 20 cm Item Code: 8888233420 Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2535-2015·2015-09-09
MAHURKAR Acute Dialysis Catheter Recalled for Potential Sterility Compromise
Covidien LLC is recalling 569 MAHURKAR 12Fr Acute Dialysis Catheters because sterility may be compromised. The products were distributed nationwide in the US.
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access…
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2688-2015·2015-09-09
Customed Recalls Lap-Cholecystectomy Surgical Packs Due to Sterilization Issues
Customed, Inc. is recalling 320 lap-cholecystectomy surgical packs distributed in Puerto Rico because of inadequate validation of sterilization processes and package integrity.
Product
LAP-CHOLECYSTECTOMY SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2559-2015·2015-09-09
Customed OB Packs Recalled for Sterilization Validation Deficiencies
Customed, Inc. is recalling 96 OB Packs CS/4 in Puerto Rico due to inadequate sterilization validation and package integrity.
Product
OB PACK CS/4 Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2582-2015·2015-09-09
Customed Plastic Surgery Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 plastic surgery packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
PLASTIC SURGERY PACK 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2665-2015·2015-09-09
Customed Tummy Tuck Pack Recalled for Sterilization Validation Issues
Customed, Inc. is recalling Tummy Tuck Packs due to inadequate validation of sterilization processes and package integrity.
Product
TUMMY TUCK PACK-FJG 6/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2702-2015·2015-09-09
Customed Incision and Drainage Trays Recalled for Sterilization Defects
Customed, Inc. is recalling 1,050 Incision and Drainage Trays distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
Product
INCISION AND DRAINAGE TRAY 50/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2664-2015·2015-09-09
Customed Face Lift Medical Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 24 units of Face Lift medical kits due to inadequate validation of sterilization processes and package integrity.
Product
FACE LIFT 4/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2629-2015·2015-09-09
Customed NEURO PACK Surgical Kits Recalled for Sterilization Defects
Customed, Inc. is recalling 64 NEURO PACK surgical kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
Product
NEURO PACK 2/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state
HighFDA (Devices)·Z-2578-2015·2015-09-09
Customed Premium Arthroscopy PK Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 55 packs of Premium Arthroscopy PK due to inadequate validation of sterilization processes and package integrity.
Product
PREMIUM ARTHROSCOPY PK CUSTOMED 5/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
Category
Medical Device
Distribution
1 state