Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

17351–17375 of 31574

HighFDA (Devices)·Z-2650-2023·2023-10-11
IceCure Cryoablation System ProSense Manual Updated for Mechanical Damage Safety
Icecure Medical Ltd is updating the user manual for IceCure Cryoablation System ProSense surgical devices to add safety guidelines for managing mechanical damage such as bent cryoprobes.
Product
IceCure Cryoablation System ProSense -Intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures Models: (1)FAS3000000 (100-127 VAC); (2)FAS3000000-2 (100-127 VAC)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0013-2024·2023-10-11
Fentanyl Injectable Solution Recalled Over Sterility Concerns
Central Admixture Pharmacy Services Inc. is recalling fentanyl injectable solution nationwide due to lack of assurance of sterility. The FDA classified this as a Class II recall.
Product
fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-5
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0040-2024·2023-10-11
Mass Spectrometer Recalled for Risk of Flame and Electrode Ejection
AB Sciex is recalling 14 Citrine Triple Quad Mass Spectrometers (Part Number 5063684) due to rare risk of solvent leak and electrical discharge potentially causing flame and electrode ejection at the ion source probe.
Product
Citrine Triple Quad Mass Spectrometer, Part Number 5063684
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0015-2024·2023-10-11
Fentanyl and Bupivacaine Injectable Syringes Recalled for Sterility Defect
Central Admixture Pharmacy Services Inc. is recalling 895 syringes of fentanyl and bupivacaine injectable solution due to lack of assurance of sterility. The recall affects all doses nationwide.
Product
fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total Volume = 50 mL, Total fentaNYL 75 mcg/50 mL, 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2080-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0031-2024·2023-10-11
FDA Recalls Hydromorphone Syringes Over Sterility Assurance Issue
Central Admixture Pharmacy Services Inc is recalling 2,664 syringes of HYDROmorphone injectable solution (30 mg/30 mL) distributed nationwide. The recall was initiated due to lack of assurance of sterility.
Product
HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0007-2024·2023-10-11
Phenylephrine Injectable Syringes Recalled for Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling phenylephrine injectable syringes nationwide due to lack of assurance of sterility. The recall affects 19,510 units distributed across multiple lot numbers.
Product
PHENYLephrine in 0.9% sodium chloride, 1,000 mcg/10 mL, (100 mcg/mL), 10 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6009-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0039-2024·2023-10-11
Citrine QTRAP Mass Spectrometer Recalled for Flammable Solvent Fire Hazard
AB Sciex is recalling ten Citrine QTRAP Mass Spectrometer units due to potential flame and electrode ejection from flammable solvent leaks combined with electrical discharge.
Product
Citrine QTRAP Mass Spectrometer, Part Number 5063685
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0070-2024·2023-10-11
Medical Convenience Kit Recalled for Defective Dermatome Blades
ROi CPS LLC is recalling a medical convenience kit containing Zimmer dermatome blades that have caused 38 complaints of thin and non-uniform skin grafts in surgical procedures.
Product
GS0008 2Y - Burn Pack - STL, Item Number 880082025
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-0022-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Boston Scientific is recalling certain lots of Guider Softip Guide Catheters due to an incorrect tip curve shape. The affected devices were distributed with a different tip curve than labeled.
Product
Guider Softip Guide Catheter 8F 100CM MULTI PURPOSE, Catalog number M003101480, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0018-2024·2023-10-11
Midazolam Injectable Solution Recalled Over Sterility Assurance Concerns
Central Admixture Pharmacy Services is recalling midazolam injectable solution syringes due to lack of assurance of sterility. Patients should not use the affected lots and consult their healthcare provider.
Product
midazolam in dextrose 5%, 50 mg/50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-4036-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2649-2023·2023-10-11
Medline CirClamp Surgical Clamp Recalled for Incorrect Assembly
Medline is recalling 106 units of Centurion Sterile CirClamp with 1.45cm bell due to kits containing an incorrect subassembly that results in incorrect bell and base size.
Product
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0022-2024·2023-10-11
Fentanyl Injection Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc is recalling 240 units of 100 mL bags of fentanyl 2500 mcg/50 mL due to lack of assurance of sterility. The product was distributed nationwide.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2659-2023·2023-10-11
Olympus SPiN Thoracic Navigation System Models Recalled for EMC Non-Conformance
Olympus is recalling SPiN Thoracic Navigation System and related models due to manufacturing non-conformances and insufficient electromagnetic compatibility (EMC) evidence. The devices may malfunction in certain electrical environments.
Product
Veran:SPiN Thoracic Navigation System Models: SYS-4230 SPiN Thoracic Navigation System - 230V 50Hz SYS-4000 SPiN Thoracic Navigation System SYS-3230 ig4 System, 230V, 50Hz / SPiN Thoracic Navigation System 0095 SYS-3000 SPiN Thoracic Navigation System SYS-240
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0024-2024·2023-10-11
Guider Softip Guide Catheter Recalled for Incorrect Tip Curve Shape
Guider Softip Guide Catheter (cardiac device) is being recalled because certain units have an incorrect tip curve shape that differs from the label. A total of 116 units have been distributed.
Product
Guider Softip Guide Catheter 5F 100CM MULTI PURPOSE, Catalog number M003101630, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0040-2024·2023-10-11
FDA Recalls Subpotent Epinephrine Injectable for Intraocular Surgical Use
Imprimis NJOF is recalling an epinephrine-lidocaine injectable due to failed potency testing, affecting nationwide distribution. The product was compounded in April 2023 for use during eye surgery.
Product
Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular injection Preservative Free NDC 71384-640-01 Not for resale. Office use only. Lot: 23APR018 Date Compounded: 24APR2023 Expires on: 17APR2024. In case of adverse event contact: www.fda.gov/medwatch or
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0029-2024·2023-10-11
HYDROmorphone Syringes Recalled for Lack of Sterility Assurance
Central Admixture Pharmacy Services is recalling 4,550 syringes of HYDROmorphone due to lack of assurance of sterility. The product was distributed nationwide.
Product
HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0019-2024·2023-10-11
Boston Scientific Guider Softip Guide Catheter Recalled for Incorrect Tip Shape
Boston Scientific is recalling Guider Softip Guide Catheters (Catalog M003101440) in certain lots due to incorrect tip curve shape that differs from the labeled specification. The recall affects 2,184 units.
Product
Guider Softip Guide Catheter 8F PRE-SHAPED 40 100CM, Catalog number M003101440, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0019-2024·2023-10-11
Fentanyl Injectable Syringes Recalled Due to Sterility Assurance Issue
Central Admixture Pharmacy Services is recalling fentanyl 100 mcg/2 mL syringes due to a lack of assurance of sterility. The affected lot was distributed nationwide.
Product
fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0014-2024·2023-10-11
Cardiac Guide Catheters Recalled for Incorrect Tip Curve Shape
Certain lots of Guider Softip Guide Catheters were manufactured with an incorrect tip curve shape that differs from labeled specifications. The recalled devices include 17,436 units distributed in Indiana.
Product
Guider Softip Guide Catheter 8F 90CM MULTI PURPOSE, Catalog number H965100480, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0012-2024·2023-10-11
Cardiac guide catheters recalled for incorrect tip curve
Boston Scientific is recalling Guider Softip Guide Catheters because certain lots were distributed with an incorrect tip curve shape that differs from labeled specifications.
Product
Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0006-2024·2023-10-11
Phenylephrine Syringes Recalled Nationwide for Sterility Assurance Failure
Central Admixture Pharmacy Services is recalling 3,081 phenylephrine injectable syringes nationwide due to lack of assurance of sterility. Affected lots expire between October 3-18, 2023.
Product
PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6008-1
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0021-2024·2023-10-11
FDA Recalls Fentanyl Injectable Syringes Due to Sterility Concerns
Central Admixture Pharmacy Services is recalling fentanyl 2500 mcg/50 mL injections nationwide due to lack of assured sterility.
Product
fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0012-2024·2023-10-11
Fentanyl injectable product recalled for lack of sterility assurance
Central Admixture Pharmacy Services is recalling fentanyl injection product due to lack of sterility assurance. No illnesses have been reported.
Product
fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2071-4
Category
Drug
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0030-2024·2023-10-11
Hydromorphone Syringe Recalled Due to Lack of Sterility Assurance
Central Admixture Pharmacy Services Inc. is recalling hydromorphone syringes due to lack of assurance of sterility. The recall affects 274 syringes distributed nationwide.
Product
HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0023-2024·2023-10-11
Guider Softip Guide Catheters recalled for incorrect tip curve shape
Boston Scientific is recalling certain Guider Softip Guide Catheters due to incorrect tip curve shape that differs from the label. The recall affects 1170 units distributed in Indiana.
Product
Guider Softip Guide Catheter 5F PRE-SHAPED 40 100CM, Catalog number M003101620, cardiac guide catheter
Category
Medical Device
Distribution
Distributed nationwide

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17351–17375 of 31574