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Browse Device Recalls

960 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 960 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 960 FDA device recalls.

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DateProductReasonClassFirm
Jul 28, 2021 Corin MetaFix Hip Stem, Size 1, Short Neck, 135 degrees, Collared Hip Stem, R... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin BIOLOX Delta Mod Head, diameter 28mm Medium 0mm, 12/14 Taper, REF 104.2... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 28, 2021 Corin Unity Knee CS Insert, Size 5 / 9.0mm, Fixed Condylar Stabilised - UHMWP... The packaging system on the devices have potential physical and water damage resulting in damage ... Class II Corin Ltd
Jul 22, 2021 BD" Mouse IgG2a Isotype Control APC X39 ASR Complaints have been received for performance issues related to high background and staining. th... Class II Becton, Dickinson and Company, BD Biosciences
Jul 14, 2021 Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water ... There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. ... Class II Maquet Medical Systems USA
Jun 17, 2021 Hemotherm CE Dual Reservoir Cooler/Heater, Model 400CE, 115V Model, part no. ... There is a potential risk of device contamination and patient infection associated with the devic... Class II Gentherm Medical, LLC
May 25, 2021 Cotton Rounds/Pads under the following brand names: 1. BEAUTY 360 Extra Lar... Potential for mold contamination (Aspergillus vadensis) Class II Medline Industries Inc
May 21, 2021 Sterile Radial/Femoral Angiography Drape, Catalog Number 29529 - Product Usag... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - Pro... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Radial/Femoral Angiography Drape, Catalog Number 29529N - Product ... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Femoral Angiography Drape, Catalog Numbers: a) 29460NB, b) 29456NB... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - P... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Numbe... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
May 21, 2021 Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Ca... The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is... Class II Cardinal Health 200, LLC
Apr 21, 2021 Rubber Dam Clamp, KSK - Product Usage: used for prevention of contamination b... Removing parts for safety reasons due to possible breakage. Class II Dentech Corp.
Apr 19, 2021 Econocare Plus Waffle Overlay- Intended for use as a medical device to aid i... Product contamination-a trace amount of dried bodily fluids may expose patients, health care prov... Class II EHOB, Inc.
Dec 16, 2020 KWIK-STIK 2 Pack, Catalog #0894P; KWIK-STIK 6 Pack, Catalog #0894K; and LYFO ... Contamination with S. epidermidis Class II Microbiologics Inc
Nov 10, 2020 PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 10, 2020 PROKERA, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 10, 2020 PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage. Potential exposure of product to microbial contamination. Class II TissueTech, Inc.
Nov 6, 2020 Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usa... Roche confirmed customer complaints of low quality (QC) recovery and invalid calibrations for the... Class II Roche Diagnostics Operations, Inc.
Oct 23, 2020 Viral Transport Medium, 3ml, Ref: R99, Container type: Tube, Packaged: 20 tub... There is a potential for contamination within Viral Transport Media. Use of contaminated Viral T... Class II Hardy Diagnostics
Oct 1, 2020 LYFO DISK(TM), LYFO DISK(TM) Streptococcus pneumoniae derived from ATCC(R) 49... Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri. Class II Microbiologics Inc
Oct 1, 2020 QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC Sets and Panels GP Co... Potential contamination with Escherichia coli Staphylococcus epidermidis and S. warneri. Class II Microbiologics Inc
Oct 1, 2020 KWIK-STIK(TM), Streptococcus pneumoniae derived from ATCC(R) 49619(TM), packa... Potential contamination with S. epidermidis E. coli and S. warneri. Class II Microbiologics Inc
Aug 31, 2020 Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Clos... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 3mL Syringe w/Spinning Spiros, Red Cap, REF: CH2003; 5mL Syringe w/Spinning S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 PermaFlo Flowable Composite REF-UP 948 Shade: A2 - Product Usage: is a light ... Due to a potential manufacturing issue (cross contamination), composite is non-homogeneous. Class II Ultradent Products, Inc.
Aug 31, 2020 31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spinning Spiros Closed Male Luer, Red Cap, REF: IB-CH2000SC; 5" (13 cm) Appx ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.2 ml, 20 Drop Admin Set w/Integrated Clave Drip Chamber, S... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 76 cm (30") Appx 3.3 ml, Admin Set, 2 Spiros w/Red Cap, 20 Drop In-Line Drip ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Appx 1.7 ml Bag Spike w/Integrated Clave, 2 Drop-In Spiros, REF: CH3260 Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 5 IN (13 cm) Appx 1.5 ml, Bag Spike Adapter, Spiros, REF: 20123-01; 75" (191 ... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 5.5 mL 20 Drop Admin Set w/Integrated Clave Drip Chamber, 1... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 Spiros CLOSED MALE LUER w/RED CAP, 25 UNITS, REF: 011-CH2000SC-25; 76 cm (30"... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 42 IN (107 cm) Appx 5.0 ml, 20 Drop Admin Set, Spiros, REF: 20131-01; 31" (79... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 31, 2020 30" (76 cm) Appx 3.3 ml, 20 Drop Admin Set w/Integrated ChemoLock Drip Chambe... Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid lea... Class II ICU Medical, Inc.
Aug 27, 2020 Tina-quant Complement C4 ver.2, Catalog 05991994190 Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... Class III Roche Diagnostics Operations, Inc.
Aug 27, 2020 Albumin Gen.2, Catalog 05166861190 Roche has confirmed customer complaints of low quality (QC) recovery and invalid calibrations for... Class III Roche Diagnostics Operations, Inc.
Aug 19, 2020 MICROFLEX Diamond Grip Examination Gloves, MF-300 - Product Usage: A patient ... Examination gloves were shipped inadvertently, without to verify barrier integrity. Class II Ansell Healthcare Products LLC
Aug 13, 2020 Critical Care Decontamination System (CCDS) Compatible N95 respirators - Pr... Masks processed at one site were not maintained at levels of condensation during a portion of the... Class II Battelle Memorial Institute
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 9.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 8.0 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 5.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC
Jul 29, 2020 PROTEXIS Latex Micro Surgical Gloves Size 7.5 - Product Usage: This surgeon s... A degradation defect was found that could lead to holes and donning tears at the folding area aro... Class II Cardinal Health 200, LLC

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.