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.

301–325 of 1010

HighFDA (Devices)·Z-1532-2024·2024-04-24
Cook Coons Taper Dilators recalled due to low packaging seal strength
Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.
Product
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORDER NUMBER (GPN): 1) JCD10.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1531-2024·2024-04-24
Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising device sterility.
Product
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER (RPN)/ORD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2024·2024-04-10
Centurion Hemostat Kits Recalled Due to Weak Seal Sterility Breach Risk
Medline Industries is recalling Centurion Hemostat kits because weak seals may allow sterile contents to become contaminated. The weak seal may not be apparent to users before the instrument is used.
Product
Centurion Hemostat kits labeled as: a) STERILE CURV KELLY HEMOSTAT, Product Code 65340; b) STERILE CURV MOSQUITO HEMOSTAT (MHS103), Product Code 66145; c) STERILE STRT KELLY HEMOSTAT (SK8039), Product Code 66170; d) STERILE CURV KELLY HEMOSTAT (CK8040), Product Code 66175
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1431-2024·2024-04-10
Centurion Dental Kits Recalled for Weak Seal Risk
Medline has recalled Centurion dental kits due to weak seals that may compromise sterility. No illnesses or injuries have been reported.
Product
Centurion kits: a) DENTAL INSTRUMENT KIT, Product Code DH760; b) STERILE COTTON DENTAL ROLLS 6/PK, Product Code 9125ST6; c) DENTAL INSTRUMENT KIT, Product Code DH760
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1449-2024·2024-04-10
Centurion Manual surgical kits recalled due to weak seals risking sterility breach
Medline's Centurion Manual surgical kits may have weak seals that fail to maintain sterility. If seals breach, microorganisms could contaminate the sterile contents, posing infection risk during surgery.
Product
Centurion Manual surgical kits labeled as: a) STERILE S/B WIRE SCISSOR, Product Code 65140; b) SHARP/SHARP SCISSORS 41/2", Product Code 65840; c) STERILE WIRE CUTTER (WCS144), Product Code 66240; d) STERILE LISTER BANDAGE SCISSOR (LS122), Product Code 66855; e) STERILE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2024·2024-04-10
Centurion Clamp kits recalled due to potential sterility breach risk
Medline Industries is recalling Centurion Clamp kits due to potential weak seals that could compromise sterility. Affected units were distributed nationwide and internationally.
Product
Centurion Clamp kits labeled as: a) STERILE BACKHAUS TOWEL CLAMP (BTC173), Product Code 66520; b) STERILE TOWEL CLAMP, Product Code A547ST; c) ST TOWEL CLAMPS NON PERFORATING (P/S), Product Code I68080; d) STERILE TOWEL CLAMPS 5 1/2, Product Code I68085; e) STERILE TOWE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1473-2024·2024-04-10
Surgical Optical Scissors Recalled Due to Inadequate Reprocessing Evidence
Karl Storz optical scissors (REF 115400S) are being recalled due to inadequate validation evidence for reprocessing procedures. The 27 affected units were distributed nationwide; users should contact the manufacturer for guidance.
Product
Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1370-2024·2024-04-03
Alcon bulb irrigation syringes recalled due to sterile barrier compromise
Alcon is recalling bulb irrigation syringes due to potential sterile barrier compromise in surgical procedure packs. Non-sterile syringes may increase infection risk.
Product
SYRINGE,BULB,2OZ/60CC,GREEN, Part: 300055070, packaged inside Alcon Custom-Pak Surgical Procedure Packs, Products: 18018-06, 3865-44, 5675-76, 13554-11, 18018-06, 15190-16 , 15190-16, 15190-16, 15190-16, 15190-16, 13554-11, 5918-39, 15190-16, 15190-16, 9208-66, 9208-66, 5675-76,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0403-2024·2024-04-03
Fentanyl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals recalls fentanyl injection syringes due to concerns about sterility. No illnesses have been reported, but patients and healthcare providers should check if they have products from the affected lot numbers, which expired in December 2023.
Product
fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = 50 mcg/mL) 50 mL Single Dose Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0202-22, Bar code 70004020022,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0399-2024·2024-04-03
FDA Recalls Fentanyl and Bupivacaine Injection Due to Sterility Concerns
SCA Pharmaceuticals is recalling 324 syringes of fentanyl/bupivacaine epidural injection nationwide due to lack of sterility assurance. Patients should contact their healthcare provider if affected.
Product
fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd, Windsor, CT 06095, NDC 70004-0231-22, Bar Code 70004023122
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0397-2024·2024-04-03
Fentanyl-Bupivacaine Epidural Injection Recalled for Sterility Assurance Failure
SCA Pharmaceuticals is recalling 242 bags of fentanyl-bupivacaine epidural injection due to lack of assurance of sterility. The affected lot may not meet required sterility standards.
Product
fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 mL Injection (fentaNYL Concentration = 2 mcg/mL), EPIDURAL USE ONLY, 100 mL Bag, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0231-32, Bar Code 70004023132
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0409-2024·2024-04-03
FDA recalls HYDROmorphone injection for lack of sterility assurance
SCA Pharmaceuticals is recalling HYDROmorphone HCl injectable syringes nationwide due to lack of sterility assurance. The FDA issued this Class II recall affecting multiple lot numbers.
Product
HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentration = 1 mg/ml) 30 mL fill 35 mL Plungerless Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-16, Bar Code 70004030316
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0412-2024·2024-04-03
Injectable midazolam HCl recalled due to sterility assurance failure
SCA Pharmaceuticals is recalling Midazolam HCl 100 mg/100 mL injectable nationwide because the manufacturer cannot assure sterility of the product. Users should consult their healthcare provider regarding affected lot numbers.
Product
Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 100 mL Bag, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0411-59, Bar Code 70004041159
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0404-2024·2024-04-03
FDA Recalls HYDROmorphone Injection Cassettes Due to Sterility Concerns
SCA Pharmaceuticals recalls 256 units of HYDROmorphone HCl injection in Grey CADD Cassettes nationwide due to lack of assured sterility. The affected lot is #1223049529 with expiration date 01/03/24.
Product
HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey CADD Cassette (20 mg/100 mL), CII, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-63, Bar Code 70004030063
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0421-2024·2024-04-03
Phenylephrine HCl Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling Phenylephrine HCl 800 mcg/10 mL injections due to lack of assurance that the product is sterile. The recall affects 2,427 syringes distributed nationwide.
Product
PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentration = 80mcg/mL) 10 mL fill 12 mL Syringe, Rx Only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0816-12-K, Bar Code 700040081612. (same finished product as F078140, but with RFID f
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0422-2024·2024-04-03
FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0407-2024·2024-04-03
Hydromorphone Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals recalls 1,023 syringes of Hydromorphone Injection nationwide due to lack of sterility assurance. No illnesses have been reported.
Product
HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentration = 0.2 mg/ml) 50 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0300-22, Bar Code 70004030022
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0402-2024·2024-04-03
fentaNYL 1,250 mcg Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling fentaNYL 1,250 mcg/25 mL injection syringes due to lack of sterility assurance. The nationwide recall affects 1,259 syringes; patients should contact their healthcare provider.
Product
fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in a 30 mL Single Dose Syringe, RX Only, repackaged by SCA Pharma. SCA Pharmaceuticals, 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0200-17, Bar code 70004020017
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0410-2024·2024-04-03
Hydromorphone Injection Recalled for Lack of Sterility Assurance
SCA Pharmaceuticals is recalling 909 syringes of HYDROmorphone HCl 30 mg/30 mL injection nationwide due to lack of assurance of sterility. Patients should not use affected lots and consult their healthcare provider.
Product
HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentration = 1mg/mL) 30 mL fill Syringe, Rx only, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0303-21, Bar Code 70004030321
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0411-2024·2024-04-03
Labetalol HCl Injection Recalled Due to Lack of Sterility Assurance
SCA Pharmaceuticals is recalling labetalol HCl injection due to lack of sterility assurance. The recall affects 2,458 syringes distributed nationwide.
Product
labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe, Rx Only, SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0700-28, Bar Code 70004070028
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1295-2024·2024-03-20
CVS Health Wound Dressing Recalled for Failed Sterility Testing
Medline Industries is recalling CVS Health Waterproof Wound Tracking Dressing (REF CVS690330) due to sterility failure. The non-sterile dressings may introduce infection risk when applied to wounds.
Product
CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0384-2024·2024-03-20
FDA Recalls HylaTears Lubricant Eye Drops for Sterility Assurance Issue
Optikem International is recalling 46,621 bottles of hyalogic For Dry Eyes, HylaTears Lubricant Eye Drops due to lack of assurance of sterility. The product is distributed nationwide.
Product
hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1236-2024·2024-03-13
Synthes 2.5MM Surgical Drill Bits Recalled Due to Unconfirmed Sterility
Synthes (USA) Products LLC is recalling 30 units of 2.5MM sterile surgical drill bits (Lot 77P6506) because sterility cannot be confirmed. Non-sterile surgical instruments pose a risk of surgical site infection if used in orthopedic procedures.
Product
2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered & accessory/attachment Product Code: 310.25S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1242-2024·2024-03-13
Synthes Opal Intervertebral Cage Spinal Implant Recall: Sterility Not Confirmed
Synthes is recalling 30 Opal intervertebral cage spinal implants (Lot 427P153) because sterility cannot be confirmed. Patients with these devices should contact their surgeon immediately.
Product
Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1237-2024·2024-03-13
Synthes RIA Tube Assembly Recalled for Unconfirmed Sterility
Synthes is recalling 144 units of RIA Tube Assembly surgical instruments due to sterility failure. The devices cannot be confirmed as sterile and pose a risk of infection if used in orthopedic procedures.
Product
RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adults and adolescents (12-21 years) to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis, to harves
Category
Medical Device
Distribution
Distributed nationwide