70 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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Bed Assist Bars, labeled as follows: a) Medline SwivAssist Bar, Model Number MDS6800SWIV (case of 3), b) Medline SwivAssist Bar, Model Number MDS6800SWIVRH (individual)
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code QTC·March 5, 2024
Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg w/o Hanger Bar, REF: 55300H-NA, patient lifts
FDA Recall
Open, Classified
·Human Care Hc Sweden Ab Arstaangsvagen 21 B Stockholm Sweden·Product code FSA·February 23, 2024
Hanger-Bar 2P 45cm
FDA Recall
Open, Classified
·Human Care USA, Inc.·Product code FSA·November 1, 2021
Hanger-Bar 2P 45cm
FDA Recall
Open, Classified
·Human Care USA, Inc.·Product code FSA·November 1, 2021
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
FDA Recall
Open, Classified
·Intrinsic Therapeutics, Inc.·Product code LXH·July 25, 2024
Molift 2-Point sling bar, an accessory for Molift Mover 205. Item nos. 1430016 1430017 1430021
FDA Recall
Open, Classified
·Moller Vital Hadelandsvegen 2·Product code FSA·February 4, 2019
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
FDA Recall
Open, Classified
·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025
Brand Name: Molift Product Name: Molift 4-point sling bars (Accessory to mobile hoists) Model/Catalog Number: 1430116,1430117,1430115 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
FDA Recall
Open, Classified
·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025
Bed Assist Bars, labeled as follows: a) Medline, Model Number BA6800, b) Medline Martha Stewart, Model Number MDS6800BAMMS
FDA Recall
Open, Classified
·MEDLINE INDUSTRIES, LP Northfield·Product code QTC·March 5, 2024
Molift 2-Point sling bar, an accessory for Molift Mover 180/Air. Item nos. 1830001 1830002 1830002C 1830003
FDA Recall
Open, Classified
·Moller Vital Hadelandsvegen 2·Product code FSA·February 4, 2019
ACMI Roller Bar Electrodes bearing incorrect pouch label of ACMI USA Elite System and USA Series Right Angle Cutting Loop Electrode Stabilized, 0.012 Wire 24 Fr (8mm), Model: REF MLE 24-012. Product packaged in boxes of 6 pouches. Box of 6 has correct box label of ACMI USA Elite System and USA Series Roller Bar Electrode 24/26 Fr (8/8.667 mm), Model: REF RB,
FDA Recall
Open, Classified
·Olympus Corporation of the Americas·Product code FAS·October 2, 2023
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork in the joint connecting the lifting bar and the arm on the Molift Mover.
FDA Recall
Open, Classified
·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025
Brand Name: Molift Product Name: Molift Mover 205 Model/Catalog Number: (1) M14000, (2) M1401, (3) M1402, (4) M14050, (5) M14150, (6) M1402-01, (7) M14050-00 (8) M14001;
FDA Recall
Open, Classified
·ETAC A/S Parallelvej 3 Gedved Denmark·Product code FSA·November 17, 2025
Custom Abutment Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 027.4620;
FDA Recall
Open, Classified
·Straumann USA LLC·Product code NHA·March 17, 2026
Custom Abutment AS Ti, for Straumann RC, incl. TAN screw; Catalog Number/Art.: 010.5438;
FDA Recall
Open, Classified
·Straumann USA LLC·Product code NHA·March 17, 2026
QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument
FDA Recall
Open, Classified
·Qiagen Sciences LLC·Product code JJH·July 2, 2019
Access Substrate, REF 81906, For use with the Access Immunoassay Systems
FDA Recall
Open, Classified
·Beckman Coulter, Inc.·Product code PPM·February 7, 2024
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
FDA Recall
Open, Classified
·Abbott Molecular, Inc.·Product code OOI·November 11, 2022
iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision Software
FDA Recall
Open, Classified
·Beta Bionics, Inc.·Product code QFG·August 13, 2025
Drugs of Abuse Tests: a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114. b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug Panel AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PPX, THC Urine Sample 25 Tests Model Number: DOA-1127-041-19. c. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (OX, pH, SG) Urine Sample 25 Tests Model Number: I-DUA-157-013. d. Instant Technologies, Inc. Drugs of Abuse Test iCup A.D. 6-Drug Panel with Adulterants AMP, BZO, COC, mAMP/MET, OPI, THC, (OX, pH, SG) Urine Sample Tests Model Number: I-DUA-167-022. e. Alere Drugs of Abuse Test iCup Dx Pro 2 10-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, OPI300, OXY, MTD, THC (CR, OX, SG) Urine Sample 25 Tests Model Number: I-DXP-2107-01. f. Alere Drugs of Abuse Test iScreen 5-Drug Panel AMP, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: IS5M. g. Instant Technologies, Inc. Drugs of Abuse Test T-Cube 7-Drug Panel AMP50, COC20, mAMP/MET50, OPI40, OXY20, PCP10, THC40 Saliva Sample 25 Tests Model Number: TCUBE-7PCPB. h. Wondfo Drugs of Abuse Test with Adulterants Tcup 14-Drug Panel AMP1000, BAR300, BZO300, BUP10, COC300, mAMP/MET1000, MDMA500, MTD300, MOP(OPI300), OXY100, PCP25, PPX300, TCA1000, THC50 (CR, pH, SG) Urine Sample 25 Tests Model Number: TDOA-1145A3. i. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, TCA, THC, (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCUPA-12CLIA. j. Instant Technologies, Inc. Drugs of Abuse Test UScreen 12-Drug Panel with Adulterants AMP, BAR, BUP, BZO, COC, mAMP/MET, MDMA, MOP, MTD, OXY, PCP, THC (CR, pH, SG) Urine Sample 25 Tests Model Number: USSCupA-12BUP300. k. Alere Drugs of Abuse Test E-Z Split Key Cup 6-Drug Panel AMP, BZO, COC, mAMP/MET, OPI, THC Urine Sample 25 Tests Model Number: DOA-2167-019. l. Alere Drugs of Abuse Test E-Z Split Key Cup A.D. 5-Drug Panel with Adulterants AMP, COC, mAMP/MET, OPI, THC (CR, GL, NI, OX, pH, SG) Urine Sample 25 Tests Model Number: DUD-157-012-019. m. WONDFO USA CO., LTD. Wondfo Drug Test Dip Card Drugs of Abuse Test Tdip Single Drug Buprenorphine (BUP) Urine Sample 25 Tests Model Number: WDBU-114.
FDA Recall
Open, Classified
·Mckesson Medical-Surgical Inc. Corporate Office
9954 Maryland Drive
Deep Run Iii Ste. 4000
Richmond VA 23233·Product code DKZ·May 25, 2022