Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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Date	Product	Reason	Class	Firm
Nov 29, 2017	BCI Advisor Vital Signs Monitor, Model 9200, Reorder numbers 920654235, 92065...	Some printing modes on the devices may not function properly (tabular data printing, real-time co...	Class II	Smiths Medical ASD Inc.
Nov 29, 2017	FEM PRC LT M/RT L SML FEM PRC RT M/LT L SML FEM PRC LT M/...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	LPS-FLEX GSF OPT SZ C-L¿ LPS-FLEX GSF OPT SZ C-R¿ LPS-FLEX GSF OPT SZ D-L¿ ...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	Rapid for the TLiIQ(R) System, HOLOGIC(R), Catalog number: 01200	Rapid fFN cassettes were manufactured with material (A137 ascites) from a new supplier (SDIX). Th...	Class II	Hologic, Inc.
Nov 29, 2017	CR-FLEX POR HATCP FEM C-L CR-FLEX POR HATCP FEM C-R CR-FLEX POR HATCP FEM D...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	smith&nephew, 2.4 MM, 6 HOLE, EVOS, FLEX PLATE, SST Plate, REF CATALOG NUMBER...	One lot of EVOS 2.4MM Flex Plate 6 Hole packaging contained templates.	Class II	Smith & Nephew, Inc.
Nov 29, 2017	Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 4...	Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEMORAL C-L LPS-FLEX OPTION FEM...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	CR OPTION FEM COMP SIZE C/L CR OPTION FEM COMP SIZE C/R CR OPTION FEM COMP ...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-R...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	VERSYS 6 INCH BEADED FC 13X160MM LM BODY EXT NECK & STD NECK Prosthesis, H...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 29, 2017	CPT 12/14 COCR SIZE 0 STD prosthesis, hip, semi-constrained, metal/polyme...	The LDPE bag packaging for various highly polished hip and knee implants may adhere to the highly...	Class II	Zimmer Biomet, Inc.
Nov 28, 2017	The GLOBAL UNITE Platform Shoulder System is intended for cemented or uncemen...	The screw in specific lots of the GLOBAL UNITE Anatomic Body and GLOBAL UNITE Fracture Body was i...	Class II	DePuy Orthopaedics, Inc.
Nov 28, 2017	lmmunalysis EDDP Urine Control Set 1 The EDDP Urine Controls (High 125 ng/...	The High (125 ng/ml) Control does not meet specification - it has been confirmed to produce value...	Class III	Alere San Diego Inc. DBA Immunalysis Corporation
Nov 28, 2017	Vital-Port Vascular Access System, Subcutaneous, implanted, intravascular inf...	Non-coring needle provided with the Cook Vital-Port¿ Vascular Assess System (Vital-Port) may cut ...	Class II	Cook Vascular Inc.
Nov 28, 2017	Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm an...	Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactu...	Class II	Stryker Neurovascular
Nov 27, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ C...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	Hemotherm¿ Dual Reservoir Cooler/Heater System Models 400CE and 400MR Produc...	Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections relate...	Class II	Cincinnati Sub-Zero Products LLC
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 14 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 16 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	AGB+ Pressure Injectable Quad- Lumen CVC Kit Product Usage: The Arrow¿ CV...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	ARROWg+ard Blue Product Usage: The Arrow¿ CVC is indicated to provide sho...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	AGB+ Pressure Injectable Multi- Lumen CVC Kit Product Usage: The Arrow¿ C...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 12 MM, REF ...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	ARROWg+ard Blue¿ Large-Bore Multi-Lumen CVC Kit Product Usage: The Arrow¿...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 18 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	Syva¿ EMIT¿ 2000 Theophylline Product Usage: The Syva¿ Emit¿ 2000 Theophy...	Lot J1 of the Syva¿ EMIT¿ 2000 Theophylline Assay, when run on a Beckman AU Clinical Chemistry S...	Class II	Siemens Healthcare Diagnostics, Inc.
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 12 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	DERMABOND" PRINEO" Skin Closure System Product Usage: DERMABOND PRINEO ...	Ethicon discovered that specific lots of DERMABOND"PRINEO"System may not dry within the specified...	Class II	Ethicon, Inc.
Nov 27, 2017	ARROWg+ard BLUE PLUS Pressure Injectable Quad- Lumen CVC Kit Product Usag...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter ...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	Pressure Injectable Multi- Lumen Central Venous Pressure Injectable ARROW(R) ...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	ARROWg+ard Blue¿ MAC" Two-Lumen Central Venous Access Kit Product Usage: ...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	ARROWg+ard BLUE PLUS Pressure Injectable Two- Lumen CVC Kit Product Usa...	Some of the products listed in the recall may be missing a sticker that contains the lot number, ...	Class II	Arrow International Inc
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.5 MM, LENGTH 16 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 27, 2017	TRYPTIK(R) 2 C-PLATE SELF-TAPPING POLYAXIAL SCREW 4.0 MM, LENGTH 14 MM, REF T...	Product labeling for TRYPTIK 2-C-PLATE Self Tapping screw, REF TRY-PS 40, Lot 3-5934 contains the...	Class II	SPINEART SA
Nov 24, 2017	U2 Total Knee System Tibial Insert, PSA, #1, 21mm Thick Catalogue number 2303...	UOC received a customer compliant report from our distributor on October 31, 2017 which stated t...	Class II	United Orthopedic Corporation
Nov 24, 2017	U2 Total Knee System Tibial Insert, Posterior Stabilized, #3, 11mm Thick Cat...	UOC received a customer compliant report from our distributor on October 31, 2017 which stated t...	Class II	United Orthopedic Corporation
Nov 22, 2017	ProLite Mesh - mesh, surgical, polymeric ProLite Mesh is intended for use ...	An incorrect ProLite Mesh configuration was packaged as product code 1010306-06, with lot number ...	Class II	Atrium Medical Corporation
Nov 22, 2017	Apollo Lap-Band AP System Small with RapidPort EZ Product Usage: The Lap...	Component of the Lap-Band system was missing from the package	Class II	Apollo Endosurgery Inc
Nov 22, 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.0 cm x 20 cm (.8 in x 8 in), Ref PC0905...	The incorrect IFU was shipped with the product.	Class III	ECOLAB INC
Nov 22, 2017	8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyuretha...	The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked ...	Class II	Medical Components, Inc dba MedComp
Nov 22, 2017	ECOLAB MICROTEK Rolled Probe Cover, 2.6 cm x 20 cm (1 in x 8 in), Ref PC0906,...	The incorrect IFU was shipped with the product.	Class III	ECOLAB INC
Nov 22, 2017	CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 100085...	Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The la...	Class II	Smiths Medical ASD Inc.
Nov 21, 2017	15 ML REAGENT CUP, B1037307, SAP 1221037307 for use with ABX PENTRA 400 / PEN...	The ABX PENTRA Reagent Containers do not always sit properly into the reagent rack. In low reage...	Class II	Horiba Instruments, Inc dba Horiba Medical
Nov 21, 2017	Rechargeable Li-ion battery used with Puritan Bennett TM 980 Series Ventilato...	Rechargeable lithium-ion batteries with incorrect firmware that are used in certain Puritan Benne...	Class II	Covidien LLC
Nov 21, 2017	OCULUS Pentacam AXL, Model 70100, software versions 1.21r01, 1.21r03, 1.21r11...	The device software versions have an anomaly which may produce an erroneous marking for the quali...	Class II	Oculus Optikgeraete GMBH
Nov 21, 2017	Santajoy Ornament & Giftware Co., Ltd E-Z Illuminations Northern Lights E-Z ...	It was discovered that the product units it imported may, at peak levels, emit radiation that ex...	Class II	SANTA JOY ORNAMENT & GIFTWARE CO

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.