BEUDAMED
    74 results · 14ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters FDA Recall × Status: Open, Classified × Clear all

    CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: 25+ TOTALPLUS CP PAK 20K CPM BWV .9 IU/ 8065000093; 25+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000095; 27+ TOTALPLUS CP PAK 20K CPM BV .9 IU/ 8065000096; 23GA BEVEL ULTRAVIT 10,000 CPM/ 8065752413; 25+ BEVEL ULTRAVIT 10,000 CPM/ 8065752415; 27+ BEVEL ULTRAVIT 10,000 CPM/ 8065752417; TOTAL PLUS,23G,10K VALVE STD/ 8065752435; TOTAL PLUS,23GA,10K VALVE WD/ 8065752436; TOTAL PLUS,25+,10K VALVE STD/ 8065752437; TOTAL PLUS,25+,10K VALVE WD/ 8065752438; TOTAL PLUS,27+,10K VALVE STD/ 8065752439; 23G CMB PAK 10K CPM,V,STD 0.9/ 8065752448; 23G CMB PAK 10K CPM,V,WA 0.9/ 8065752449; 25+ CMB PAK 10K CPM,V,STD 0.9/ 8065752450; 25+ CMB PAK 10K CPM,V,WA 0.9/ 8065752451; 27+ CMB PAK 10K CPM,V,STD 0.9/ 8065752452; 25+TTLPL VPK 20000CPM BEV VAL/ 8065753106; 27+TTLPL VPK 20000CPM BEV VL/ 8065753109; HYPERVIT 25+BEV 20000 CPM/ 8065830026; HYPERVIT 27+BEV 20000 CPM/ 8065830027; 25+ TTL PLUS VPAK 20000CPM BWV/ 8065830077; 25G VIT 25G OPTICARE EYE HLTH CTR/ 10924-15; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-25; VITRECTOMY 25G NORTHSIDE HOSP/ 11220-27; 23G CONSTELLATION NORTHERN MICH SPPLY AL/ 12568-09; AUS-25GA VIT RET BRISBANE WATERS/ 12641-13; AUS-25GA VIT RET BRISBANE WATERS/ 12641-14; AUS-23GA 10K COMBINED VR PAK NEW CHILDRE/ 12852-16; 23G VIT CONSTELLATION LOMA LINDA COMM HO/ 13501-08; 25+G 20K VIT CONSTELLATION LOMA LINDA CO/ 13502-10; 23G VIT CONSTELLATION VALVED BAYSTATE ME/ 13591-13; 25G CONSTELLATION VALVED BAYSTATE MEDICA/ 13592-15; VITRECTOMY 25G V A HOSPITAL/ 14129-10; J-COMB PAK - 25G 20K CVS NAKAGAMI HOSPIT/ 14283-12; CDN-CVS VIT 25G VE 10K TIMMINS DH/ 14501-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-09; CDN-CVS VIT 25G+ VE 10K CIUSSS MCQ/ 14512-10; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-06; CDN-CVS VIT 23G 10K WA SASKATOON HR/ 14532-07; CDN-CVS VIT 10K 25G+ HSC, ST JOHN'S/ 14540-08; CDN-CVS COMBO 23G VE 10K HD KINGSTON/ 14541-16; CDN-CVS VIT 25G+ 20K BV JEWISH GH/ 14597-07; CDN-CVS VIT 23G 10K ROCKYVIEW HOSPITAL/ 14603-15; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-10; CDN-CVS COMBO 25G VE 10K TIMMINS DH/ 14669-11; CDN-CVS VIT 23G VE ROYAL ALEXANDRA HOSP/ 14671-09; CDN-CVS VIT 25G+ 10K ROCKYVIEW HOSPITAL/ 14672-11; CDN-CVS VIT 25G+ BWV 20K CUSM/MUHC/ 14873-06; CDN-CVS VIT 25G+ BWV 20K CUSM-MUHC/ 14873-07; CDN-VIT 23G VE 10K ST MICHAEL'S HOSP/ 14955-08; CDN-VIT 23G VE 10K ST MICHAELS HOSP/ 14955-09; CDN-CVS 25G+ VIT VE 10K ST MICHAEL'S/ 14956-07; CDN-CVS 25G+ VIT VE 10K ST MICHAELS/ 14956-08; CDN-CVS VIT 25G+ 10K WESTERN MH/ 15006-06; CDN-CVS VIT 25G+ 20K WA WESTERN MH/ 15006-07; CDN-CVS COMBO 23G 10K ROCKYVIEW HOSPITAL/ 15108-09; CDN-CVS CMB 25G+ V 10K OAKVILLE-TRAFALGA/ 15167-08; 25G PLUS VITRECTOMY PEACE HEALTH ST JOSE/ 15223-13; CDN-VIT 23G 10K GRM741746 CUO-HSS/ 15294-14; CDN-COMBO 23G 10K GRM741759 CUO-HSS/ 15295-12; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-05; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-06; CDN-CVS VIT 25G+ VE 10K MISERICORDIA HC/ 15318-07; CDN-CVS COMBO 23G V 10K ST MICHAEL'S HSP/ 15324-07; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-13; CDN-COMBO 25G 20K GRM743287 CUO-HSS/ 15421-14; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-08; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-09; CDN-UHN 23G COMBO VE 10K TORONTO WESTERN/ 15455-10; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-04; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-05; CDN-UHN 23G VIT VE 10K TORONTO WESTERN/ 15456-06; CDN-CVS 23G COMBO VE 10K SUNNYBROOK GH/ 15464-05; CDN-CVS 23G VIT VE 10K SUNNYBROOK GH/ 15465-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-05; 23G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15491-06; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-02; 27G VIT PACK CALLAHAN EYE FOUNDATION HOS/ 15492-03; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-05; 25G+ VIT PACK CALLAHAN EYE FOUNDATION HO/ 15493-06; CDN-CVS VIT 25G+ 10K PASQUA HOSPITAL/ 15525-04; CDN-CVS COMBO 23G VE 10K KENSINGTON EI/ 15552-05; CDN-CVS 23G VIT VE 10K KENSINGTON EYE IN/ 1

    FDA Recall
    Open, Classified ·Alcon Research LLC·Product code HQB·September 15, 2025

    CVS PCSU SJH, REF SJCV48J

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code LRO·September 1, 2023

    Brand Name: CVS Honey Pad Product Name: CVS Honey Pad Model/Catalog Number: 9370613, 937404 Product Description: Infused with natural medical-grade honey Manuka (Leptospermum) honey is a medical-grade honey that is harvested from bees in New Zealand. Researchers have found that this species has unique components that make it ideal for wounds.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·August 5, 2025

    (1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.

    FDA Recall
    Open, Classified ·ASO LLC·Product code FQM·June 22, 2022

    Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of the Randox Cystatin C assay on automated analysers Catalog Number: CVS 2699

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code NDY·February 14, 2024

    NxStage Cartridge Express with Speedswap, Catalog No. CAR-535. An accessory device for facilitating the removal and replacement of a flow-compromised filter during treatment of acute and chronic renal failure or fluid overload.

    FDA Recall
    Open, Classified ·NxStage MDS Corporation·Product code KDI·January 29, 2024

    SQ40S Blood Transfusion Filter

    FDA Recall
    Open, Classified ·GVS TM, Inc·Product code CAK·November 3, 2025

    CVS Health Waterproof Wound Tracking Dressing, REF CVS690330, immediate package contains 1 sterile dressing, 4 in. x 4 in., 4 dressings per box, 24 boxes per case.

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code NAC·January 23, 2024

    Private Label CVS. Model Number: CVS405406. Helps maintain a moist wound environment, which has shown to be conducive to wound healing. Intended for minor scalds & burns, minor cuts, lacerations & minor abrasions.

    FDA Recall
    Open, Classified ·Integra LifeSciences Corp. (NeuroSciences)·Product code FRO·January 16, 2026

    ROSA One 3.1 Brain application The device is intended for the spatial positioning and orientation of instruments holders or tool guides to be used by trained surgeons to guide standard surgical instruments during brain and spine surgeries.

    FDA Recall
    Open, Classified ·MEDTECH SAS 900 Rue Du Mas De Verchant Montpellier France·Product code HAW·September 22, 2021

    Medtronic REF: MMT-7020C Guardian Sensor (3) kit for the following packaging: GS3 SEMI 5PK OUS/ GTIN: 20763000192086, 5PK SF NEW GS3 OUS/GTIN: 20763000358451 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Vaginal Delivery, ASDV25B; Medical convenience kit

    FDA Recall
    Open, Classified ·American Contract Systems, Inc.·Product code MLS·August 7, 2024

    AMERICAN CONTRACT SYSTEMS, Medical Procedure kits and trays labeled as: 1) BORN ON ARRIVAL KIT, Model/Item Number LLBN11C; 2) LABOR & DELIVERY PACK, Model/Item Number LLLD19I.

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·July 14, 2025

    LABOR & DELIVERY PACK, Model Nos LLLD19H

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·February 6, 2025

    BORN ON ARRIVAL KIT , Model No LLBN11B

    FDA Recall
    Open, Classified ·American Contract Systems Inc·Product code MLS·February 6, 2025

    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.

    FDA Recall
    Open, Classified ·Product code MLS·September 30, 2025

    Medline Kits: 1) LABOR PACK-22025208-LF, Model Number: DYNJ44813D

    FDA Recall
    Open, Classified ·Product code MLS·February 25, 2026

    Medtronic, REF: MMT-7008A, Enlite Glucose Sensor for the following packaging: ENLITE PLUS 5PK 23L 1CL /GTIN: 20643169541706, ENLT PLUS 5PK 2L 1CL PR/ GTIN: 20643169786725, ENLITE PLUS 5PK 23L 1CL/ GTIN: 20763000421292 - Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    Medtronic REF: MMT-7020D4 Guardian Sensor (3) for the following packaging: GS3 1PK 2L CANADA/ GTIN: 00763000179595 Product Usage: intended for use with Medtronic Diabetes (Medtronic) glucose sensing systems to continuously monitor glucose levels in persons with diabetes. *Product not distributed within US.

    FDA Recall
    Open, Classified ·Medtronic Inc.·Product code MDS·February 26, 2021

    regard Item Number: 830106006, LD01114F - Newborn Kit containing the component Neo-Tee Resuscitator. Convenience kit to be used in Labor and Delivery.

    FDA Recall
    Open, Classified ·ROi CPS LLC·Product code MLS·December 26, 2024