Browse Device Recalls

2,602 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,602 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 2,602 FDA device recalls in 2020.

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DateProductReasonClassFirm
Sep 9, 2020 TWINFIX ULTRA PLLA HA 6.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 Uroskop Omnia Max, Model no. 10762473 - Product Usage: a solid state detector... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 BIORAPTOR 2.9MM SUTURE ANCHOR-Absorbable Suture anchor Product Number: 72201702 Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 6.5 W/2 UB (BLUE & BLK)- Absorbable Suture anchor Product N... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** Si... Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the s... Class II Encore Medical, LP
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 6.5MM AB PRELOADED SUTURE ANCHOR- Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX AB 5.0 SUTR ANCHR W/2 38 DURAB-Absorbable Suture anchors Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA/HA 5.5 W/3 UB-Absorbable Suture anchor Product Number: 72... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 VICRYL MONOFILAMENT VIOLET 4IN (10CM) USP 10-0 (M0.2) SINGLE-ARMED CS140-6 - ... Product in the foil package for VICRYL V960 may not match the foil label and sales unit carton. T... Class II Ethicon, Inc.
Sep 9, 2020 HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BL-- Absorbable Suture anchor Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA HA 5.5 W/2 UB BLUE & BLK- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY-REVERSE CURVE-Absorbable Suture anchor Product Nu... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.3 W/ 1 UB COBRAID BLACK-Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR-Absorbable Suture anchors Product Number: 721... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W. 2 UB WHITE / BLACK -Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 ULTRA FAST-FIX AB ASSEMBLY - STRAIGHT-Absorbable Suture anchors Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 MICRORAPTOR REGENESORB SUTURE ANCHOR- Absorbable Suture anchor Product Numbe... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR CRVD 2.3 SA UB COBRD BLUE- Absorbable Suture anchor Product Numb... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.9 W 1UB II BLUE--Absorbable Suture anchor Product Number: 7220... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX ULTRA PLLA HA 5.5MM W/ NEEDLES- Absorbable Suture anchor Product Num... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 Uroskop Omnia, Model no. 10094910 - Product Usage: a solid state detector flu... After the March 2019 corrective action on the monitor support arm, there is a residual risk of th... Class II Siemens Medical Solutions USA, Inc
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 TWINFIX 5.0MM AB SUTURE ANCHOR WITH TWO- Absorbable Suture anchors Product ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 9, 2020 OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: ... Product packaging improper or incomplete seal of the pouch surrounding the sterile product may re... Class II Smith & Nephew, Inc.
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector, L26mm, S4C CROSS CONNECTOR FIXED 26MM, ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L22mm, S4C CROSS CONNECTOR FIXED 22MM, p... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnet... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 MediCult Vitrification Cooling Media, Model Number 12284001F There is a discrepancy between the printing on the Product Tyvek label of the individual componen... Class II CooperSurgical, Inc.
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 AC/DC POWER SUPPLY for 7400, Part Number 151004300, XP Power Model Number AHM... The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ... Class II ESAOTE S.P.A
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 28-33mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 33-42mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L 42-58mm, S4C CROSS CONNECTOR VARIABLE ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 8, 2020 System, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body m... Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet. Class II GE Healthcare, LLC
Sep 8, 2020 AC/DC POWER SUPPLY for 7400, Part Number 151004301, XP Power Model Number AHM... The AC/DC adapter (power supply) of the portable ultrasound systems listed below that may result ... Class II ESAOTE S.P.A
Sep 8, 2020 AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, ... Insufficient clamping force of the cross connectors in the spinal surgical system which may lead ... Class II Aesculap Implant Systems LLC
Sep 7, 2020 Neoprobe GDS Control Unit, Model Number NPCU3 It was discovered during a documentation review that China has the software version as v5.01 appr... Class III Devicor Medical Products Inc
Sep 4, 2020 Biomet OnPoint SCOPE PROCEDURE KIT Item Number: 24-3050 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 1500 Flex Heat and Moisture Exchanger, Catalog Reference 150 - Product Usage:... Firm has received 6 complaints that the Heat Moisture Exchanger (HME) disconnected from the close... Class II AB ULAX
Sep 4, 2020 B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a singl... Recalled products do not have FDA approval for sale in the United States. Class II Braxton Medical Corporation
Sep 4, 2020 Biomet Regenerex Primary Taper Cap Item Number 141269 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 4, 2020 Biomet ONPOINT SCOPE PROCEDURE KIT-EU Item Number: 24-3055 Product not properly being aligned with the adequate gamma sterilization group and result in the... Class II Biomet, Inc.
Sep 3, 2020 (1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom: Acetabular Bi-Polar C... Zimmer Biomet is conducting a medical device recall for three lots of the RingLoc Bi-Polar Hip sy... Class II Biomet, Inc.
Sep 3, 2020 CarePoint 60 mL Syringe Without Needle, REF: 04-7560 Syringe without needle may have a green substance on the plunger. Substance found to be nontoxic ... Class II Allison Medical, Inc.
Sep 2, 2020 GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: ... The firm has identified lots of calibrators that have shown to measure incorrect high values over... Class II Gentian AS

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.