18 results
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16ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
FDA Recall
Open, Classified
·Universal Meditech Inc.·Product code NGE·May 22, 2023
IV Administration Set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. NF1505, IV ADMIN SET W/2 H.F. STOPCOCKS; Catalog Number: 490088. 2. IV ADMIN SET W/2 SAFELINE & HF STOPCOCK; Catalog Number: 490107.
FDA Recall
Open, Classified
·B Braun Medical Inc·Product code FPA·October 29, 2025
MB215R - MILLS DUROGRIP TC Micro Needle Holder, straight, 8:, (203 mm), "TC MILLS NDLE HOLDRRND HNDLSTR203MM"
FDA Recall
Open, Classified
·Aesculap Inc·Product code HCF·December 29, 2023
CODMAN Disposable Perforator 9mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
CODMAN Disposable Perforator, 14mm. Cranial perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·April 11, 2025
MB362R - JACOBSON DUROGRIP TC Micro Needle Holder, straight, 8 3/4", (220 mm), "TC JACOBSON NDL HLD STR JAW 220MM";
FDA Recall
Open, Classified
·Aesculap Inc·Product code HCF·December 29, 2023
CODMAN Disposable Perforator 11mm. Cranial Perforator.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·September 26, 2025
CODMAN Craniotomy Kit, Disposable Perforator Cranio-blade Wire Pass Drill, 14mm. Cranial perforator kit.
FDA Recall
Open, Classified
·Integra LifeSciences Corp. (NeuroSciences)·Product code HBF·April 11, 2025
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 12 TESTS Model/Catalog Number: 1023770 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 12 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
FDA Recall
Open, Classified
·HF Acquisition Co LLC·Product code FRC·April 13, 2026
Biological, Bio52 HealthFirst Mail In Monitoring System, 52 Tests, Item: 1003600. Biological, Bio12 HealthFirst Mail In Monitoring System, 12 Tests, Item: 1003580
FDA Recall
Open, Classified
·HF Acquisition Co LLC·Product code FRC·December 11, 2024
Brand Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Product Name: SPORETRAQ MAIL-IN SPORE TESTING SERVICE, 52 TESTS Model/Catalog Number: 1023780 Software Version: N/A Product Description: The SporeTraq Mail-In Spore Testing Service includes 52 bacterial Spore Strips provided by Mesa Labs. The Spore Strip (single species G. stearothermophilus ATCC#7953 or dual species G. stearothermophilus ATCC #7953 and B. atrophaeus ATCC #9372) is intended for use in testing the efficacy of sterilizer systems used in healthcare facilities. The Spore Strips are compatible with Steam sterilization, Chemiclave sterilization, Ethylene Oxide sterilization, or Dry Heat sterilization processes. The test strip is placed in the customer s sterilizer during their sterilization cycle and upon completion the sterilized test strip along with the control strip is returned to Mesa Labs for lab testing in the return envelope. Spore test results are digitally stored in HealthFirst s OnTraq smart automation tracking and reporting system for easy and secure access to a paperless archive from any device with internet access. Component: N/A
FDA Recall
Open, Classified
·HF Acquisition Co LLC·Product code FRC·April 13, 2026
RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption Kit, REF: L-621100; Ratchet Lock Body, REF: L-692020
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISH·May 12, 2023
Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code IQK·August 20, 2024
RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic component
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·March 25, 2024
Power Knee, REF: PKA10001, and PKA10003; with Power Knee Battery, REF: PKA10002
FDA Recall
Open, Classified
·Ossur H F Grjothals 5 Reykjavik Iceland·Product code ISW·December 26, 2023