Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

14251–14275 of 53090

HighFDA (Drugs)·D-0314-2023·2023-02-22
Penicillin Intravenous Antibiotic Recalled Over Lack of Sterility Assurance
Sentara Infusion Services is recalling eight bags of intravenous penicillin antibiotic due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS), (c) 48MU IN D5W 480ML, antibiotic, Rx Only, use with a Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·F-0350-2023·2023-02-22
Lemon Almond Blueberry Bread recalled for undeclared soy lecithin
Heidi Remington is recalling 76 packages of Lemon Almond Blueberry Bread distributed in Oregon due to undeclared soy lecithin in a releasing agent spray. Soy is a major allergen posing risk to consumers with soy allergies.
Product
Lemon Almond Blueberry Bread, UPC 7 21762 76434 3, Net wt.3.5oz (98g). The sliced Lemon Blueberry Bread is wrapped in a clear plastic shrink wrap. The label stated "***Lemon Almond Blueberry Bread* Malted barley wheat flour, milk, eggs, almonds...Contains: Wheat, eggs, milk…
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0284-2023·2023-02-22
FDA Recalls D5 NS Injectable Solution for Lack of Sterility Assurance
Sentara Infusion Services is recalling D5 NS 2300mL, an injectable dextrose-saline solution, due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0279-2023·2023-02-22
Injectable Cefazolin-Heparin Syringes Recalled Nationwide for Lack of Sterility Assurance
Sentara Infusion Services is recalling compounded Cefazolin/Heparin injectable syringes due to lack of sterility assurance. Eight syringes with a December 2022 beyond-use date are affected.
Product
CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1134-2023·2023-02-22
SIEMENS Biograph Horizon 3R Mobile PET gantry locking mechanism defect
Siemens is recalling the Biograph Horizon 3R Mobile PET/CT system due to a potential failure of the locking mechanism that secures the PET gantry in its scanning or service position. The system has been distributed worldwide.
Product
SIEMENS Biograph Horizon 3R Mobile; System, Tomography, Computed, Emission
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·23V109000·2023-02-22
2022 Rivian R1S and R1T passenger air bag deployment failure
A faulty seat belt sensor in 2022 Rivian R1S and R1T vehicles may suppress or prevent air bag deployment during a crash. Affected owners should contact Rivian customer service at 1-888-748-4261 for a free replacement.
Product
RIVIAN — RIVIAN R1T, R1S
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0288-2023·2023-02-22
Dextrose 10% TPN Solution Recalled Due to Sterility Assurance Concerns
Sentara Infusion Services is recalling Dextrose 10% 720ML TPN injectable solutions nationwide due to lack of sterility assurance. Patients using this product should contact their healthcare provider.
Product
Dextrose 10% 720ML, TPN, Rx only, use with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0313-2023·2023-02-22
FDA Recalls Pantoprazole Injectable Syringes for Sterility Assurance Failure
Sentara Infusion Services is recalling Pantoprazole 30mg intravenous syringes due to lack of sterility assurance. The product was dispensed to patients nationwide.
Product
PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0282-2023·2023-02-22
Ceftriaxone Injectable Antibiotic Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Ceftriaxone antibiotic infusions nationwide because the manufacturer cannot assure the products meet sterility standards. Patients should contact their healthcare provider.
Product
CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, antibiotic, Rx only, used in a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0283-2023·2023-02-22
Ceftriaxone injectable antibiotic recalled for lack of sterility assurance
Sentara Infusion Services recalled 72 bags of ceftriaxone injectable antibiotic due to lack of sterility assurance. The affected product was distributed nationwide with a beyond-use date of December 24–31, 2022.
Product
CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a Curlin or Home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0286-2023·2023-02-22
Daptomycin Antibiotic Injectable Syringes Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Daptomycin pre-filled syringes distributed nationwide due to lack of sterility assurance. Patients using this antibiotic should contact their healthcare provider immediately.
Product
DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG IN NS 31.5ML used with a home pump; antibiotic, Rx only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0289-2023·2023-02-22
Diphenhydramine 18mg Injectable Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Diphenhydramine 18mg syringes distributed nationwide due to lack of sterility assurance. The 15-bag recall affects injectable antihistamine products that may pose an infection risk if used.
Product
Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0278-2023·2023-02-22
Cefazolin Antibiotic Injections Recalled Due to Sterility Assurance Failure
Sentara Infusion Services is recalling Cefazolin antibiotic injections due to lack of sterility assurance. The recall affects 111 bags and 21 syringes distributed nationwide.
Product
CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE, (d) 3GM IN NS 150ML, antibiotic, used with a curlin, home or no pump assigned. Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0318-2023·2023-02-22
Sentara TPN Products Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling 26 bags of Total Parenteral Nutrition (TPN) solutions distributed nationwide because the manufacturer cannot assure the products maintain sterility. Patients receiving these products should contact their healthcare provider.
Product
TPN (a) 100GM/AA, 285GM/DEX, (b)55GM/LIP 2300ML, (c)55GM/AA 285GM/DEX 50GM/LIP1800ML, (d)TPN AA:100GM DEX:250GM LIP:50GM 2400ML, (e) 55GM DEX:285GM 1800ML, Rx Only, use with Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1124-2023·2023-02-22
Surgical convenience kits recalled for compromised external packaging sterility
Medline Industries is recalling 1,588 surgical kits nationwide due to a perforated bag design that prevents the outside of the kit wrapping from remaining sterile.
Product
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0270-2023·2023-02-22
New & Improved Blue Gel Anesthetic Recalled Nationwide for API Discoloration
HTO Nevada, Inc. is recalling 4,709 bottles of New & Improved Blue Gel Anesthetic nationwide due to discoloration of the epinephrine active pharmaceutical ingredient resulting from a cGMP deviation in the raw material supply.
Product
New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0276-2023·2023-02-22
Ampicillin/Sulbactam antibiotic injection recalled due to sterility concerns
Sentara Infusion Services is recalling Ampicillin/Sulbactam 3GM intravenous bags due to lack of sterility assurance. The affected product was dispensed nationwide to home infusion patients.
Product
Ampicillin/Sulbactam 3GM IN NS 100ML, antibiotic, Rx only, used with a home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2023·2023-02-22
Surgical convenience kits recalled for sterile barrier defect
Medline Industries recalls 1537 Lab Draw Kits (Reorder #DYNDH1641A, Lot 22HMH339) distributed nationwide due to a perforated outer bag that cannot maintain sterility, compromising the protective barrier.
Product
Surgical convenience kits labeled as: MEDLINE LCPH LAB DRAW KIT, Reorder Number DYNDH1641A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1109-2023·2023-02-22
Surgical convenience kits recalled for compromised sterility packaging
MEDLINE PAIN TRAY surgical convenience kits (120 units, Lot #22EBA798) are recalled nationwide because a perforated outer bag compromises the sterile barrier. Only the contents inside the kit's inner wrapping remain sterile.
Product
Surgical convenience kits labeled as: MEDLINE PAIN TRAY, Reorder Number DYNJRA1122A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2023·2023-02-22
Potential Gantry Locking Mechanism Defect in SIEMENS Biograph mCT PET Scanners
The SIEMENS Biograph mCT PET scanner has a potential issue with the locking mechanism that secures the gantry. Six units distributed worldwide including the US, Japan, Chile, and Australia are affected.
Product
SIEMENS Biograph mCT: a) Flow 64-4R Seismic, b) S(40)-3R Seismic, c) S(64)-3R Seismic, d) S(40)-4R Seismic, e) S(64)-4R Seismic, f) S(20)-3R Mobile
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0320-2023·2023-02-22
TPN parenteral nutrition bags recalled due to lack of sterility
Sentara Infusion Services is recalling 31 TPN bags due to lack of sterility assurance. The recalled bags with Beyond Use Dates December 24–31, 2022, were dispensed nationwide to patients.
Product
TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (c) TPN AA: 100GM DEX: 105GM 2700ML, (d) TPN AA: 100GM DEX: 105GM LIP: 45GM 2700ML, (e) TPN: AA100GM ; DEX185GM ; LIP50GM IN 1500ML, (f) TPN: AA 150GM ; DEX 220GM ; LIP 45GM IN 2400 ml, (g)…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2023·2023-02-22
Surgical Convenience Kits Recalled for Compromised Sterility Assurance
Medline Industries is recalling surgical convenience kits with reorder number DYNJCD0063 due to a perforated bag that fails to keep the kit's outer wrapping sterile. Affected units were distributed nationwide.
Product
Surgical convenience kits labeled as: MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0296-2023·2023-02-22
Hydromorphone Infusion Recalled for Lack of Sterility Assurance
Sentara Infusion Services is recalling Hydromorphone injectable solutions due to lack of sterility assurance. The recall affects 37 bags distributed nationwide.
Product
HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 and NDC 00409-2634-50) ; (b) 5MG/ML IN NS 60ML, 100ML, 250ML; pain, Rx only, used with a Curlin pump or no pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA…
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0301-2023·2023-02-22
Levaquin 750MG Injectable Recalled Due to Lack of Sterility Assurance
Sentara Infusion Services is recalling 14 bags of Levaquin 750MG injectable antibiotic dispensed nationwide due to lack of sterility assurance. The product was distributed to patients for home infusion pump use.
Product
Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320,
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0300-2023·2023-02-22
Lactated Ringers IV Solution Recalled for Sterility Assurance Failure
Sentara Infusion Services is recalling Lactated Ringers IV solutions (NDC 00338-0117-03) due to lack of sterility assurance. The recall affects 25 bags dispensed nationwide with a Beyond Use Date of December 24-31, 2022.
Product
Lactated Ringers packaged in volume of 1000ML, 2500ML, 3000 ML, 3600 ML, 500ML (NDC 00338-0117-03)hydration, Rx Only, use with Curlin pump, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy, Ste 300, Chesapeake, VA 23320
Category
Drug
Distribution
Distributed nationwide