Browse Device Recalls

3,037 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,037 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 3,037 FDA device recalls.

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Date	Product	Reason	Class	Firm
Feb 10, 2020	Medline Stick Sponge Presaturated W/PVP REF DYND70288 DYND70288H 2/PK Expirat...	Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ...	Class II	Medline Industries Inc
Jan 21, 2020	Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 e...	The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz...	Class II	Medline Industries Inc
Jan 21, 2020	Medline ROBOTIC-LF REF CDS984543B Lot 20AKA927 Expiration 2020-09-30 GTI...	The sterile pack inside the Complete Delivery System (CDS) did not go through a complete steriliz...	Class II	Medline Industries Inc
Jan 13, 2020	Teleflex Medical Disposable Aortic Punch, in the following sizes: a) 2.8 mm,...	There is a potential for the device packaging to become compromised; thus, the sterility of the d...	Class II	TELEFLEX MEDICAL INC
Jan 13, 2020	Pilling Aortic Punch, 4.0 mm Standard Tip, REF 353440	There is a potential for the device packaging to become compromised; thus, the sterility of the d...	Class II	TELEFLEX MEDICAL INC
Dec 30, 2019	TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intende...	Due to a potential for sterile barrier breach. A complaint was received that indicated the protec...	Class II	Smith & Nephew, Inc.
Dec 19, 2019	STAINLESS STEEL REPROCESSING TRAY, 2D CAMERA HEAD, IS4000, Model No. 400499-...	Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz...	Class II	Intuitive Surgical, Inc.
Dec 19, 2019	STAINLESS STEEL REPROCESSING TRAY, 8MM ENDOSCOPE, IS4000, Model No. 400498-02...	Small but detectable holes in the sterilization wrap used with the firm's 8 mm endoscope steriliz...	Class II	Intuitive Surgical, Inc.
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-21, Item Code CL925 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 36 VIOLET GS-24, Item Code CL915 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture UD 4/0 18 P-13, Item Code SL5690 - Product...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture UD 3/0 30 P-14, Item Code SL5679 - Product...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 VIOLET 30" V-20, Item Code GL124 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 UNDYED 36" GS-21, Item Code CL953 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 VIOLET 36" GS-21, Item Code CL923 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 VIOLET 30" V-20, Item Code GL123 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 UNDYED 30" V-30 (75CM), Item Code GL22...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 13-0 VIOLET 30" GS-23, Item Code CL892 - P...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30"VIOLET GU-46, Item Code UL878 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" VIOLET GU-46, Item Code UL877 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 36 VIOLET GS-24, Item Code CL914 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 VIOLET 30" CV-24 (75CM), Item Code CL4...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIOLET CVF23, Item Code UL203 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 12"" VL SS-24 D/A, Item Code L1742K - ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 1 30 VIOLET GS-22, Item Code CL885 - Produ...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2-0 UNDYED 30" V-20, Item Code GL323 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30 VIOLET GS-11, Item Code CL815 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2/0 30 VIOLET GS-21, Item Code CL811 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Biosyn Monofilament Absorbable Suture 6/0 30" VIOLET CV-23, Item Code UM201	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 3/0 30" UNDYED V-20, Item Code GLS322 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 4/0 30 VIO SC-2 124K, Item Code SL654 - Pr...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 2 36" VIOLET GS-24, Item Code CL911 - Prod...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 0 30" UNDYED HOS-11, Item Code CL537 - Pro...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6-0 18" UNDYED SS-24 D/A, Item Code L2752K...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 18, 2019	Polysorb Braided Absorbable Suture 6/0 18" UNDYED P-10, Item Code SL1625G - P...	There is a potential for packaging integrity issues impacting the humidity or sterility barrier o...	Class II	Covidien LLC
Dec 17, 2019	VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:871921...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) Vitre...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv
Dec 17, 2019	VitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719...	Microscopic tears of the sterile pouch may compromise sterility	Class II	Vitreq Bv

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.