The Recall Desk

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.

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.

2901–2925 of 3429

  • HighFDA (Devices)·Z-1364-2015·2015-04-08

    Biomet Recalls Ziploop Button and ToggleLocs Due to Packaging Seal Issues

    Biomet, Inc. is recalling 50 units of Ziploop Buttons and ToggleLocs manufactured in 2014 because sterile packaging was not properly sealed.

    Product
    Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1326-2015·2015-04-01

    Ameda One-Hand Manual Breast Pump Recalled for Lack of Sterilization

    Ameda, Inc. is recalling 1,763 units of the One-Hand Manual Breast Pump (SKU 17161) because the devices were not sterilized.

    Product
    Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1327-2015·2015-04-01

    Ameda Dual Short Term HygieniKit Milk Collections System Recalled for Lack of Sterilization

    Ameda is recalling its Dual Short Term HygieniKit Milk Collections System because the devices were not sterilized. Consumers should stop using the product and contact the manufacturer.

    Product
    Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breas
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0416-2015·2015-03-25

    Heritage Pharmaceuticals Recalls RIFAMPIN for Injection Due to Sterility Concerns

    Heritage Pharmaceuticals is recalling RIFAMPIN for Injection, USP, 600 mg per vial, due to quality control concerns regarding the assurance of sterility.

    Product
    RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724 NDC 23155-340-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1274-2015·2015-03-25

    Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals

    Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain catheter kits because open seals may compromise product sterility.

    Product
    BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1262-2015·2015-03-18

    Medela Recalls Sterile Enteral Feeding Syringes Due to Packaging Breach

    Medela Inc. is recalling sterile enteral feeding syringes because a potential packaging breach may have compromised their sterility.

    Product
    - NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) - NGF-60 60ml Nutrio Gra
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2015·2015-03-11

    Zipline Medical Recalls Zip 8M Wound Closure Devices Due to Sterility Concerns

    Zipline Medical is recalling Zip 8M Wound Closure Devices because the manufacturer's seal may be missing, compromising sterility assurance.

    Product
    Zip 8M Wound Closure Device; for wounds up to 8 cm in length; Product number PS9080; Rx only, Sterile Indicated for use during and after skin incision procedures to approximate skin and hold together skin edges until healing can take place.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2015·2015-02-11

    Baxter Integrated APD Set Recalled for Leakage Complaints

    Baxter Healthcare is recalling 8,640 units of Integrated APD Sets with Cassette 3-Prong due to leakage complaints. The sterile fluid path is used for peritoneal dialysis.

    Product
    Baxter Integrated APD Set with Cassette 3-Prong, Sterile, nonpyrogenic fluid path. Product Usage: The recall device is indicated for use in the treatment of patients with renal failure to provide PD fluid exchanges with Baxter HomeChoice PD Systems in clinical and home use s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0344-2015·2015-01-28

    Walgreens Recalls Cefoxitin Infusion Bags Due to Sterility Concerns

    Walgreens Infusion Services is recalling Cefoxitin in normal saline bags due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Cefoxitin various strength in normal saline bags
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0374-2015·2015-01-28

    Walgreens Recalls L-cysteine Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling L-cysteine products due to a lack of sterility assurance. The affected products were distributed in six southern states.

    Product
    L-cysteine various strengths
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0360-2015·2015-01-28

    Walgreens Recalls Tigecycline Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling Tigecycline in normal saline due to a lack of sterility assurance. The products were distributed in six southern states.

    Product
    Tigecycline various strengths in normal saline
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0357-2015·2015-01-28

    Walgreens Recalls Ceftriaxone Infusions Due to Sterility Concerns

    Walgreens Infusion Services is recalling ceftriaxone in normal saline due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Ceftriaxone various strengths in normal saline
    Category
    Drug
    Distribution
    6 states
  • SevereFDA (Drugs)·D-0366-2015·2015-01-28

    Walgreens Recalls Folic Acid Syringes Due to Sterility Concerns

    Walgreens Infusion Services is recalling folic acid pre-drawn syringes due to a lack of sterility assurance. The products were distributed in six states.

    Product
    Folic acid 1 mg/ 0.2 ml pre-drawn syringes
    Category
    Drug
    Distribution
    6 states
  • HighFDA (Devices)·Z-0895-2015·2015-01-07

    Atricure CryoICE Cryogenic Probe Recalled for Potential Sterility Compromise

    Atricure Inc is recalling 19,190 CryoICE cryogenic probes due to packaging defects that may have compromised sterility.

    Product
    Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches Product Usage: Cryogenic probe for cardiac ablation surgery. The CryoICE cryoablation probe is a sterile, single use device intended to use in the cryosurgical treatment of cardiac arrhythmia
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0312-2015·2014-12-31

    Vann Healthcare Pharmacy Recalls Tri-mix #4 Due to Sterility Concerns

    Vann Healthcare Pharmacy is recalling Tri-mix #4 vials because an FDA inspection found deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility.

    Product
    Tri-mix #4 (Papaverine 30 mg, Phentolamine 1 mg, Prostaglandin-1 10 mcg/mL), packaged in 10 mL sterile glass vials, Rx, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Devices)·Z-0759-2015·2014-12-24

    Stryker Laparoscopic Scissors Recalled for Sterilization Instructions Error

    Stryker Endoscopy is recalling 180,573 units of 3mm Peritoneal Scissors because the instructions for use do not support specific sterilization methods.

    Product
    PKG, 3MM INSERT, PERITONEAL SCISSORS, 20CM, P/N 0250282001 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) p
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0579-2015·2014-12-17

    ArthroCare Medical Recalls Ambient HipVac and KVac Wands for Sterile Barrier Breach

    ArthroCare Medical Corporation is recalling 23,119 Ambient HipVac and KVac wands due to a potential breach of the sterile barrier caused by defective product trays.

    Product
    Model Number ASHA4730-01: Ambient HipVac 50 Wand with Integrated Finger Switches and Model Number ASHA5050-01: Ambient KVac Wand with Integrated Finger Switches. The Wands are indicated for the resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessel
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0527-2015·2014-12-17

    Alcon Single-Use Iris Bipolar Forceps Recalled for Lack of Sterilization

    Alcon Research, Ltd. is recalling single-use iris bipolar forceps labeled as sterile but not sterilized prior to shipment.

    Product
    Alcon Single-Use Curved Jewelers/Iris Bipolar Forceps REF 8065129101 Sterile RX only; Alcon Single-Use Straight/Iris Bipolar Forceps REF 8065129501 Sterile RX only. Usage: Electrosurgical instrument for ophthalmic surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0490-2015·2014-12-10

    Gambro Recalls Polyflux Dialyzers Due to Potential Packaging Tears

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Max Dialyzer, Model Number 110634. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0489-2015·2014-12-10

    Gambro Recalls Polyflux Revaclear Dialyzers Due to Packaging Defects

    Gambro Renal Products Inc is recalling Polyflux Revaclear and Max Dialyzers because potential tears in the packaging may compromise the sterile barrier.

    Product
    Polyflux Revaclear Dialyzer, Model Number 110633. The Polyflux Revaclear¿ and Polyflux Revaclear¿ Max Dialyzers are single use devices intended for the treatment of acute and chronic renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0492-2015·2014-12-10

    Ethicon Recalls PERMA-HAND Silk Suture Due to Sterility Assurance Concerns

    Ethicon is recalling PERMA-HAND silk sutures because the company cannot ensure the products meet the expected sterility assurance level.

    Product
    Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0493-2015·2014-12-10

    Bard Access Systems Recalls Non-Sterile GuardIVa Antimicrobial Hemostatic IV Dressing

    Bard Access Systems is recalling non-sterile GuardIVa Antimicrobial Hemostatic IV Dressing units that could potentially be used clinically.

    Product
    GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access Systems, Inc. USA. Product Code FP23AD006.
    Category
    Medical Device
    Distribution
    4 states
  • SevereFDA (Drugs)·D-0262-2015·2014-12-03

    Perry Drug Recalls Leuprolide Micro Lupron Kits Due to Sterility Concerns

    Perry Drug Inc. is recalling Leuprolide 50 mcg/0.1 mL Micro Lupron Kits in Kansas and Missouri due to potential sterility assurance risks identified during an FDA inspection.

    Product
    Leuprolide 50 mcg/0.1 mL Micro Lupron Kit, 5Ml, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-1124-57
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0266-2015·2014-12-03

    Perry Drug Recalls Tri-mix Antidote Syringes Due to Sterility Concerns

    Perry Drug Inc. is recalling Tri-mix Antidote syringes in Kansas and Missouri due to potential sterility assurance issues identified during an FDA inspection.

    Product
    Tri-mix Antidote 10 each Syringes, Compounded Rx, Perry Drug Compounding Pharmacy, Overland Park, KS --- NDC 88888-0205-17
    Category
    Drug
    Distribution
    2 states