Medline Industries recalls
344 recent recalls on record for Medline Industries in connected official government data as of October 22, 2026 at 12:00 PM UTC.
Models with recalls
All Medline Industries recalls
FDA Class II · Medical device · October 14, 2026
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…
Official ID Z-0087-2027 ·
Official record ↗
FDA Class II · Medical device · October 14, 2026
The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the fr…
Official ID Z-0086-2027 ·
Official record ↗
FDA Class I · Medical device · October 7, 2026
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…
Official ID Z-3228-2026 ·
Official record ↗
FDA Class I · Medical device · October 7, 2026
Potential fire hazard involving the hand control pendant and associated wiring used with affected beds. Pendant or pendant wiring may overheat, potentially leading to smoking, spar…
Official ID Z-3227-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Official ID Z-3269-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Official ID Z-3268-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Official ID Z-3267-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Official ID Z-3266-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r…
Official ID Z-3265-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as…
Official ID Z-3230-2026 ·
Official record ↗
FDA Class II · Medical device · September 30, 2026
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as…
Official ID Z-3229-2026 ·
Official record ↗
FDA Class II · Medical device · September 23, 2026
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…
Official ID Z-3210-2026 ·
Official record ↗
FDA Class II · Medical device · September 23, 2026
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…
Official ID Z-3209-2026 ·
Official record ↗
FDA Class II · Medical device · September 23, 2026
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…
Official ID Z-3208-2026 ·
Official record ↗
FDA Class II · Medical device · September 23, 2026
Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o…
Official ID Z-3207-2026 ·
Official record ↗
FDA Class II · Medical device · September 23, 2026
The kits contain a Retrograde Coronary Sinus Perfusion (RCSP) cannulae that has the potential for a sterile barrier breach. Sterility of the product cannot be assured. If a comprom…
Official ID Z-3137-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3127-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3126-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3125-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3124-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3123-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3122-2026 ·
Official record ↗
FDA Class I · Medical device · September 23, 2026
The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu…
Official ID Z-3121-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3079-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3078-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3077-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3076-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3075-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3074-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3073-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3072-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3071-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3070-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3069-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3068-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or incomplete seal on the app…
Official ID Z-3067-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3063-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3062-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3061-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3060-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3059-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3058-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3057-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3056-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3055-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3054-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3053-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3052-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3051-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3050-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3049-2026 ·
Official record ↗
FDA Class II · Medical device · September 9, 2026
The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi…
Official ID Z-3048-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3029-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3028-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3027-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3026-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3025-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3024-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3023-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3022-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3021-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3020-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Kits contain a potentially contaminated component which were recalled by the manufacturer
Official ID Z-3019-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Component labeling discrepancy
Official ID Z-2999-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Official ID Z-2997-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Official ID Z-2996-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Official ID Z-2995-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification lev…
Official ID Z-2994-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Official ID Z-2993-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Official ID Z-2992-2026 ·
Official record ↗
FDA Class II · Medical device · September 2, 2026
Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke,…
Official ID Z-2991-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Official ID Z-2926-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Official ID Z-2925-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Official ID Z-2924-2026 ·
Official record ↗
FDA Class II · Medical device · August 19, 2026
Medline Micro-Kill Bleach Germicidal Bleach Wipes may exhibit a reduction in bleach concentration to levels below specification prior to the end of the labeled 12-month shelf life.…
Official ID Z-2923-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Official ID Z-2791-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Official ID Z-2790-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Official ID Z-2789-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Official ID Z-2788-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2787-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2786-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2785-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2784-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2783-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2782-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2781-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2780-2026 ·
Official record ↗
FDA Class II · Medical device · July 29, 2026
Affected kits contain recalled Bard Silastic Foley Catheters. Catheters were recalled by manufacturer due to increased amount of raw material present on the surface of the catheter…
Official ID Z-2779-2026 ·
Official record ↗
FDA Class I · Medical device · July 29, 2026
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…
Official ID Z-2765-2026 ·
Official record ↗
FDA Class I · Medical device · July 29, 2026
The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP, which were recalled due to quality issues that co…
Official ID Z-2764-2026 ·
Official record ↗
FDA Class I · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Official ID Z-2749-2026 ·
Official record ↗
FDA Class I · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Official ID Z-2748-2026 ·
Official record ↗
FDA Class I · Medical device · July 29, 2026
Medline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in Dextrose Injection, USP. B. Brau…
Official ID Z-2747-2026 ·
Official record ↗
FDA Class II · Medical device · July 22, 2026
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…
Official ID Z-2737-2026 ·
Official record ↗
FDA Class II · Medical device · July 22, 2026
Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Health consequences from use of produc…
Official ID Z-2736-2026 ·
Official record ↗
FDA Class II · Medical device · July 15, 2026
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2697-2026 ·
Official record ↗
FDA Class II · Medical device · July 15, 2026
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2696-2026 ·
Official record ↗
FDA Class II · Medical device · July 15, 2026
Convenience Kits contain Covidien Mon-a-Therm General Purpose Temperature Probes Size 9 Fr. Medtronic has issued a recall of specific production lots of the Covidien Mon-a-Therm ge…
Official ID Z-2695-2026 ·
Official record ↗
FDA Class I · Medical device · July 8, 2026
Expansion of RES 98277. Specific lots of reprocessed catheters may contain small particles of residual material. If devices with residual particulates on patient-contacting surface…
Official ID Z-2615-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2613-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2612-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2611-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2610-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2609-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2608-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2607-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th…
Official ID Z-2606-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2547-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2546-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2545-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2544-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2543-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2542-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2541-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2540-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2539-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2538-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2537-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2536-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2535-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2534-2026 ·
Official record ↗
FDA Class II · Medical device · July 8, 2026
The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu…
Official ID Z-2533-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2596-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2595-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2594-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2593-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2592-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2591-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2590-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2589-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2588-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2587-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2586-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2585-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2584-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2583-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2582-2026 ·
Official record ↗
FDA Class II · Medical device · July 1, 2026
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Official ID Z-2581-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Official ID Z-2455-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Official ID Z-2454-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Official ID Z-2453-2026 ·
Official record ↗
FDA Class I · Medical device · July 1, 2026
The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were rec…
Official ID Z-2452-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2508-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2507-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2506-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2505-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2504-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2503-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2502-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2501-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2500-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2499-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2498-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2497-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2496-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2495-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2494-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2493-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2492-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2491-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2490-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2489-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2488-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2487-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2486-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2485-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2484-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2483-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2482-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2481-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2480-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac…
Official ID Z-2479-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2447-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2446-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2445-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2444-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2443-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2442-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2441-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2440-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2439-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2438-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2437-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2436-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2435-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2434-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2433-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2432-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2431-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2430-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2429-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2428-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2427-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2426-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2425-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2424-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2423-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2422-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2421-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2420-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2419-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2418-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2417-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2416-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2415-2026 ·
Official record ↗
FDA Class II · Medical device · June 24, 2026
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
Official ID Z-2414-2026 ·
Official record ↗
FDA Class II · Medical device · June 3, 2026
Specific Medline Kits contain Cardinal Health Monoject 1mL Luer Lock Syringes, Tuberculin Print, Sterile. Cardinal Health has recalled these syringes because the outer carton and b…
Official ID Z-2260-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2237-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2236-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2235-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2234-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2233-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2232-2026 ·
Official record ↗
FDA Class I · Medical device · June 3, 2026
Medline kits were distributed containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP, which was subsequently recalled due to quality issues, including microbiology t…
Official ID Z-2231-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2148-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2147-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2146-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2145-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2144-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2143-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2142-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2141-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2140-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2139-2026 ·
Official record ↗
FDA Class I · Medical device · May 20, 2026
Medline has identified the presence of particulate within the fluid path of the Manifolds.
Official ID Z-2138-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2130-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2129-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2128-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2127-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2126-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2125-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2124-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2123-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2122-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2121-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2120-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2119-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2118-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2117-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2116-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2115-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2114-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2113-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2112-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2111-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2110-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2109-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2108-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2107-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2106-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2105-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2104-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2103-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2102-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2101-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2100-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2099-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2098-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2097-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2096-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2095-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2094-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2093-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2092-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2091-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2090-2026 ·
Official record ↗
FDA Class II · Medical device · May 13, 2026
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packag…
Official ID Z-2089-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2045-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2044-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2043-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2042-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2041-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2040-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Cardinal Health has deemed Web…
Official ID Z-2039-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2038-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2037-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2036-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2035-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2034-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2033-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2032-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2031-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2030-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2029-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2028-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2027-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2026-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2025-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2024-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2023-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2022-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2021-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2020-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2019-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2018-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2017-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2016-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2015-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2014-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2013-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2012-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2011-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2010-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2009-2026 ·
Official record ↗
FDA Class II · Medical device · May 6, 2026
During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-o…
Official ID Z-2008-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1892-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1891-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1890-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1889-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1888-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1887-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1886-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1885-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1884-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1883-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1882-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1881-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1880-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1879-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1878-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1877-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
Unapproved design changes to the products outside of the 510(k) clearance.
Official ID Z-1876-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1850-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1849-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1848-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1847-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1846-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1845-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1844-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1843-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1842-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1841-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1840-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1839-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1838-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1837-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1836-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1835-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1834-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1833-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1832-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1831-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1830-2026 ·
Official record ↗
FDA Class II · Medical device · April 29, 2026
The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded.
Official ID Z-1829-2026 ·
Official record ↗
Compiled from official public-domain government data. Last checked October 22, 2026 at 12:00 PM UTC.