Category

Medical Devices Recalls

15,654 medical devices recalls on record from CPSC, FDA, and USDA.

15,654 recalls
High RiskFDA
Tei Biosciences, Inc.
SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, 13x25 cm, 25x40 cm, 20...
Medical Devices·13,390 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend 1.0; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 18x12 cm Thin and 10x15 cm Thin.
Medical Devices·52 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed ...
Medical Devices·30,528 affected·May 23, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Centurion Sterile CirClamp with 1.45cm Bell Reprocessed, Reorder CR3145K, 1 per package, 12 per case.
Medical Devices·106 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Medical Devices·1,689 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.5 cm (3 pack), 10x12cm, 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, and 8x8 cm.
Medical Devices·4,159 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
PriMatrix Ag Fenestrated; Dermal Repair Scaffold; Rx Only; Sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, 8x8 cm.
Medical Devices·7,264 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
Revize; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x10 cm, 4x12 cm, 4x16 cm.
Medical Devices·199 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
Revize-X; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 12x6 cm and 10x9 cm.
Medical Devices·665 affected·May 23, 2023
High RiskFDA
Tei Biosciences, Inc.
SurgiMend MP; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm, 20x20 cm, 13x25 cm, 16x20 cm, 20x25 cm, 20x30 cm, ...
Medical Devices·3,992 affected·May 23, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10
Medical Devices·1,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Rapid Detection Pregnancy Test Midstream REF 100-17 3 TESTS
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS Pregnancy Test Midstream REF 100-17
Medical Devices·3,304 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio KETONE TEST STRIPS REF 900-1KET 100 STRIPS/+50 FREE
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
Lem Fertility hCG Pregnancy Urine Test REF 100-12
Medical Devices·2,500 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13
Medical Devices·4,103 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
OMTMO One Step Ovulation (LH) Test Strips REF 200-07
Medical Devices·40,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
One Step Pregnancy Test REF 100-01
Medical Devices·147,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS¿ One Step FSH Menopausal Test (Strip) REF 210-07
Medical Devices·2,400 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
PrestiBio Ovulation and Pregnancy Strips REF 100-4 and REF 200-4 60 LH Test Strips/+30 HCF Test Strips
Medical Devices·0 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13
Medical Devices·25,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS One Step LH Ovulation Test Strip REF 200-07
Medical Devices·525 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27
Medical Devices·1,000 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
HealthyWiser UriTest" UTI Test Strips REF 900-UTI
Medical Devices·5,960 affected·May 22, 2023
High RiskFDA
Universal Meditech Inc.
DiagnosUS hCG Pregnancy Urine Test Strip Format REF 100-12
Medical Devices·5,025 affected·May 22, 2023
High RiskFDA
Zimmer, Inc.
NexGen Precoat Stemmed Tibial Plate Size 5
Medical Devices·0 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Sensitive Skin Sensor, REF TS-SE-3; Oximeter
Medical Devices·2,097 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal AllFit Sensor: a) REF TS-AF-10, 10 pcs; B) REF AF-25, 25 pcs; Oximeter
Medical Devices·36,337 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Integrated Ear Sensor with Ohmeda Connector REF TS-E4-H; Oximeter
Medical Devices·237 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Medical Devices·7 affected·May 19, 2023
High RiskFDA
Baxter Healthcare Corporation
Voalte Patient Safety, Part Number 4.0, V4.0.000 to 4.0.401, used with the Centrella Bed
Medical Devices·8 affected·May 19, 2023
CriticalFDA
Ge Healthcare Finland Oy
TruSignal Integrated Ear Sensor with Datex Connector, REF TS-E4-GE; Monitor, physiological, patient(with arrhythmia detection or alarms)
Medical Devices·2,707 affected·May 19, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) TOTAL JOINT, Model Number CDS985555S; b) TOTA...
Medical Devices·4,500 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: OISC HAND BEAR, Model Number DYNJ902348L
Medical Devices·128 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: TOTAL KNEE THEDA, Model Number DYNJ908683A
Medical Devices·144 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
Medical Devices·183,240 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: BREAST BIOPSY TRAY, Model Number SPEC0130C
Medical Devices·1,240 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC INFANT INSERTION PACK, Model Number CVI4770...
Medical Devices·572 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: KIT,SUCTION CATH,14FR W/WATER, Model Number DYND41472
Medical Devices·24,192 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: ARTHROSCOPY PACK, Model Number DYNJ44322G
Medical Devices·180 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) LACERATION TRAY, Model Number DYNDL1134A; b...
Medical Devices·11,413 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PROBE COVER PACK, Model Number DYNDA1219
Medical Devices·51,200 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b)...
Medical Devices·8,974 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PACK ENDO AAA HYBRID CHRG, Model Number DYNJ60126B
Medical Devices·25 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) ARTERIAL LINE START KIT , Model Number ART920; ...
Medical Devices·70,648 affected·May 18, 2023
High RiskFDA
Medline Industries, Lp - Northfield
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: PEDIATRIC EP PACK, Model Number DYNJ45158A
Medical Devices·36 affected·May 18, 2023