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Browse Device Recalls

20 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 20 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 20 FDA device recalls.

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DateProductReasonClassFirm
May 6, 2025 HardyCHROM CRE, selective and differential culture medium for antimicrobial s... Identified lots failed incoming quality control testing. Lots exhibited breakthrough growth of Kl... Class II Hardy Diagnostics
Dec 1, 2021 HARDY DIAGNOSTICS CatScreen, 25dsk/vial Product stored incorrectly in temperature controlled setting instead of refrigeration. Class II MEDLINE INDUSTRIES, LP - Northfield
Apr 16, 2021 Quickslide GramPro 1 Automated Gram Stanier is a microscope slide stainer. Instruments were assembled and serviced using a defective lot of tubing, which is part of the pum... Class II Hardy Diagnostics
Dec 21, 2020 Brain Heart Infusion Agar with 6 ug/ml Vancomycin Cat no: G14 Lot no: 472698 ... Complaints were received reporting of Staphylococcus aureus (ATCC 29213) breakthrough when the st... Class II Hardy Diagnostics
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 6, 2020 Strep B Carrot Broth One-Step, Ref. Z40, UDI: 00819398026499 Streptococcus culture medium contains an incorrect expiration date. The culture medium outer box... Class III Hardy Diagnostics
Nov 14, 2019 HardyCHROM MRSA,REF; G307, LOT: 447694, A selective and differential chromoge... False Positive results due to the MSSA (methicillin-susceptible) strain Staphylococcus aureus (AT... Class II Hardy Diagnostics
May 24, 2016 QuickSlide MGS-80, Automated Mutli-Slide Gram Stainer/GramPRO-80. Systemat... Discrepant culture and gram stain results, which could potentially lead to misdiagnosis or improp... Class II Hardy Diagnostics
Mar 21, 2016 Hardy Diagnostics GBS Detect Cat no. A300. Used for the isolation and det... Performance failure; poor hemolytic reaction of non or weakly hemolytic group B streptococcus (GB... Class II Hardy Diagnostics
Nov 18, 2015 FB Broth, 10ml (Fastidious Bacteria Broth) Cat. no: K31 Lot: 15231 A f... The firm is recalling FB Broth Cat. no. K31, Lot no. 15231 because of potential Burkholderia fung... Class II Hardy Diagnostics
Jul 9, 2015 HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container... Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough ... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BEA Broth with Vancomycin container type: 13x100mm tube... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics MDR Acinetobacter container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BEA Agar with Vancomycin container type: 15x100mm monop... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics MacConkey Agar with CiPRP, 1ug/ml Container type: 15x10... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BHI with CIPRO, 1ug/ml container type: 16x100mm tube p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate p... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 26, 2015 Hardy Diagnostics VRE Broth, 5ml container type: 16x100mm tube packaged:... Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin, Brain Heart Infusion Broth with... Class II Hardy Diagnostics
Jun 24, 2015 HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 ... Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Class II Hardy Diagnostics
Mar 4, 2015 Hardy Diagnostics cat no. G327 HardyCHROM SS Agar (HardyCHROM Salmonella Shi... The firm is recalling HardyCHROM SS, Cat. no. G327 Lot no. 15037 due to a report of possible lack... Class II Hardy Diagnostics

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.