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.

2401–2425 of 3438

HighFDA (Devices)·Z-2003-2016·2016-06-22
Zimmer Dome Centric Shoulder Implant Component Recalled for Assembly Issues
Zimmer GmbH is recalling 177 Dome Centric components from the Anatomical Shoulder System 2.0 because they may be difficult to disassemble during surgery, potentially causing delays or incomplete procedures.
Product
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0. The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning. The Anatomical Shoulder System is intended for long-term…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1991-2016·2016-06-22
CarboFix Recalls Piccolo Composite Tibia and Femoral Nailing System Guide Wires
CarboFix Orthopedics is recalling 638 Piccolo Composite Ball Tip Guide Wires because the internal package was compromised, potentially affecting sterility.
Product
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Category
Medical Device
Distribution
19 states
SevereFDA (Drugs)·D-0949-2016·2016-06-08
Akorn Recalls Sulfacetamide Sodium Ophthalmic Solution Due to Sterility Concerns
Akorn, Inc. is recalling specific lots of Sulfacetamide Sodium Ophthalmic Solution because they failed antimicrobial effectiveness testing, raising concerns about sterility.
Product
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1849-2016·2016-06-08
Curity All Purpose Sponges Recalled Due to Compromised Sterility
FDA is recalling Curity All Purpose Sponges due to compromised sterility from a barrier breach. The recall affects units distributed in the US and 20 other countries.
Product
Curity All Purpose Sponges, Non-woven, 4 Ply, Soft Pouch, 4" x 4" (10.2 cm x 10.2 cm) Item Number: 8047
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1847-2016·2016-06-08
Curity Gauze Sponges Recalled for Compromised Sterility
Covidien LLC is recalling Curity Gauze Sponges because a breach of the barrier packaging may have compromised their sterility.
Product
Curity Gauze Sponges, 16 ply 4" x 4" (10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number: 397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0943-2016·2016-06-08
Baptist Health Recalls Vancomycin IV Bags Due to Sterility Concerns
Baptist Health Medical Towers Pharmacy is recalling 59 bags of Vancomycin 1000 mg in 250 mL 0.9% NS due to a lack of sterility assurance.
Product
Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Category
Drug
Distribution
1 state
SevereFDA (Devices)·Z-1852-2016·2016-06-08
Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
Product
Curity X-Ray Detectable Laparotomy Sponges, Tray Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number: 6022
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1856-2016·2016-06-08
Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges because a breach of the barrier packaging may have compromised their sterility.
Product
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 4" x 18" (10.2 cm x 45.7 cm) Item Number: 6545
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1857-2016·2016-06-08
Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a breach of the barrier.
Product
Curity" X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 8" x 36" (20.3 cm x 91.4 cm) Item Number: 6556
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1851-2016·2016-06-08
Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
Product
Kerlix" X-Ray Detectable Laparotomy Sponges, Tray Pack, 8" x 32" (20.3 cm x 81.3 cm) Item Number: 4037
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1854-2016·2016-06-08
Curity X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Curity X-Ray Detectable Laparotomy Sponges due to compromised sterility caused by a barrier breach.
Product
Curity X-Ray Detectable Laparotomy Sponges, Soft Pouch Pack, 18" x 18" (45.7 cm x 45.7 cm) Item Number:6522
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1858-2016·2016-06-08
FDA Recalls Vistec X-Ray Detectable Sponges Due to Sterility Breach
The FDA is recalling Vistec X-Ray Detectable Sponges because a breach in the packaging barrier may have compromised their sterility.
Product
Vistec X-Ray Detectable Sponges, 16 Ply, 8" x 4" (20.3 cm x 10.2 cm) Item Number: 7319
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1870-2016·2016-06-08
Windstone Medical Recalls General Surgery Packs with Medtronic Sponges
Windstone Medical Packaging is recalling General Surgery Packs containing Medtronic Kerlix sponges due to potential sterile barrier compromise at the packaging seal.
Product
General Surgery Pack, part number 006880-3. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1869-2016·2016-06-08
Windstone Medical Recalls Laparotomy Packs Due to Sterile Barrier Concerns
Windstone Medical Packaging is recalling 40 units of Laparotomy Pack Latex Free (part number 007725-7) because the included Medtronic Kerlix sponges may have compromised sterile barriers.
Product
Laparotomy Pack Latex Free, part number 007725-7. This is a custom convenience surgical instrument disposable kit. There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1883-2016·2016-06-08
Greatbatch Medical Recalls Torque Limiting Devices Due to Sterility Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not achieve the required sterility assurance level when steam sterilized.
Product
Torque Limiting Screwdriver: Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only. PRECIMED, Non Sterile. Zimmer, Non Sterile, Rx Only. Screwdriver: Customer Number/Model: 804-03-038 T11623, T14001 T14001, MTO35173507 T14378, MTO375173506…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1882-2016·2016-06-08
Greatbatch Medical Recalls Torque Limiting Handles Due to Sterility Failure
Greatbatch Medical is recalling torque limiting handles because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Product
Torque Limiting Handle: PRECIMED, T-Handle Torque, Non Sterile. Handle: Customer Number/Model: MCL120014 T14000, TLT911-50-S20 TLT911-50-S20, TLT911-15-S01 TLT911-15-S01, TLTS0007-20-S19 TLTS0007-20-S19, TLT911-35-S01 TLT911-35-S01.
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1884-2016·2016-06-08
Greatbatch Recalls Torque Limiting Devices Due to Sterility Assurance Failure
Greatbatch Medical is recalling torque limiting devices because laboratory testing showed they do not meet required sterility levels after steam sterilization.
Product
Torque Limiting Adapter: Torque Limiting Attachment, Non Sterile, Distributed by Zimmer. PRECIMED, Torque Limiting Adaptor, Non Sterile.. Customer Number/Model: 00-2360-080-00 T10232, T116245 T116245, TLA025-25 TLA025-25, 00-2360-080-05 T10233, MAC21003…
Category
Medical Device
Distribution
3 states
HighFDA (Devices)·Z-1850-2016·2016-06-08
Kerlix X-Ray Detectable Laparotomy Sponges Recalled for Sterility Breach
The FDA is recalling Kerlix X-Ray Detectable Laparotomy Sponges due to compromised sterility from a barrier breach.
Product
Kerlix X-Ray Detectable Laparotomy Sponges, Tray Pack, 17" x 26" (43.2 cm x 66 cm) Item Number: 4031
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1792-2016·2016-06-01
American Surgical Delicot X Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Delicot X sponges due to packaging defects that compromise sterility. The recall covers 3 boxes distributed worldwide.
Product
American Surgical Delicot X 6 mm x 50 mm Ref Number: 63x06 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1772-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ray-Cot sponges because defective packaging may compromise sterility. The recall covers 16 boxes distributed worldwide.
Product
American Surgical Ray-Cot 3" x 3" Ref Number: 60-15 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1721-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Defects
American Surgical Company is recalling 351 boxes of Delicot sponges because defective packaging may compromise sterility. The products were distributed worldwide.
Product
American Surgical Delicot 15mm x 20mm Ref: 63-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1750-2016·2016-06-01
American Surgical Ultracot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling Ultracot sponges because defective packaging may compromise sterility. The recall covers 6 boxes distributed worldwide.
Product
American Surgical Ultracot 15 mm x 15 mm (Glassine) Ref Number: 23-12G Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1781-2016·2016-06-01
American Surgical Delicot Sponges Recalled for Packaging Sterility Compromise
American Surgical Company is recalling Delicot non-xray sponges because defective packaging compromises sterility. The recall covers 4 boxes distributed worldwide.
Product
American Surgical Delicot non-xray 10 mm x 13 mm Ref Number: 63-03 non-xray Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1761-2016·2016-06-01
American Surgical Cotton Balls Recalled for Packaging Sterility Defects
American Surgical Company is recalling 3 boxes of 1-inch non-strung cotton balls due to packaging defects that compromise sterility.
Product
American Surgical Cotton Balls-Non-Strung 1" Ref Number: 31-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1770-2016·2016-06-01
American Surgical Ray-Cot Sponges Recalled for Packaging Sterility Defect
American Surgical Company is recalling 102 boxes of Ray-Cot 1" x 1" sponges because defective packaging compromises sterility.
Product
American Surgical Ray-Cot 1" x 1" Ref Number: 60-12 Product Usage: Neurosurgical and Nonneurosurgical Sponges
Category
Medical Device
Distribution
Distributed nationwide