Browse Device Recalls

86 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 86 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 86 FDA device recalls.

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DateProductReasonClassFirm
Jul 21, 2022 Medline CHEST TUBE REORDER NO: DYNJ36762A Due to a non-sterile component (tape) being place within the sterile portion of the Chest Tube Co... Class II Medline Industries Inc.
Oct 27, 2021 Neuro Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Bedside PICC CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Major Vascular CDS Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 Venous Access Pack-LF Convenience Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Oct 27, 2021 EVLP Convenience Pack/Kit NaCl 250 mL Bag Inj expired 04/2020 while the kit expiration date was after 04/2020. Class II Medline Industries Inc
Aug 6, 2021 NAMIC Manifolds. (1) NAMIC Angiographic MANIFOLD, Medium Pressure, REF ... Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... Class II Medline Industries Inc
Aug 6, 2021 NAMIC Stopcocks: (1) NAMIC STOPCOCK, 200 psi (14 bar), REF 70015002, UPN H... Potential for sterile barrier breach. Microscopic pinholes within the sterile pouch could potent... Class II Medline Industries Inc
Jul 1, 2021 Medline Shoulder CDS convenience kits, REF DYNJ902837D and REF DYNJ902837F, c... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 Medline Total Knee, convenience kit, REF DYNJ907129B, containing expired com... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 Medline Knee Arthroscopy Kit, convenience kit, REF DYNJ902838C, containing e... The kits may contain an expired component. Class II Medline Industries Inc
Jul 1, 2021 Medline Arthroscopy Kit, convenience kit, REF DYNJ904304B, containing expire... The kits may contain an expired component. Class II Medline Industries Inc
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
Apr 30, 2021 Medline Tissue Recovery Instrument Set, Reorder #DYNJ64347A, packaged 3/case,... The devices may not meet the minimum required sterility assurance level. Class II Medline Industries Inc
Mar 15, 2021 Diluent, Stat-Site B-HB, 6x 3ML - Product Usage: Intended to be used with the... Possible false negative or false positive results due to the product being compromised during shi... Class II Medline Industries Inc
Jan 25, 2021 RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: mon... Product was compromised during shipment. Class II Medline Industries Inc
Jan 15, 2021 S-O303000 CONTROL, STAT-SITE B-HB, 2X3ML,1LOW,1HIGH - Product Usage: intended... Medline Industries, Inc. is removing specific lots of STAT-Site¿ Controls (Low and High) S-O30300... Class III Medline Industries Inc
Nov 13, 2020 Simple Neck Dissection, Model DYNJ47481C - Product Usage: This is a type of c... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Thyroid Pack CKHA-LF, Model DYNJ50352B - Product Usage: This is a type of con... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Greffe Aorte-LF (product info is in French); Model DYNJ31877F - Product Usage... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Cardiac Pack - LF, Model DYNJ31903I - Product Usage: This is a type of conven... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 13, 2020 Resect. Intest. Laparo-LF, Model DYNJ42667A - Product Usage: This is a type o... The cylindrical sponge component is not x-ray detectable. Class II Medline Industries Inc
Nov 5, 2020 RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressin... RevMedX Trauma Dressing is being recalled due to package seal integrity. Class II Medline Industries Inc
Oct 1, 2020 The Quidel Triage BNP Calibrators Product compromised during shipment. Class II Medline Industries Inc
Sep 15, 2020 Quick Release Gait Belt, 60 The buckle on the Gait Belt may break due to degradation of the material due to exposure to gamma... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65193091, MTO Left Heart Kit - Product Usage: NAMIC Cath Lab and I... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650305414, MTO Left Heart with DT Boulder Com Hosp - Product Usage... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650301023, MTO Radiology Kit Cleveland Clinic - Product Usage: NAM... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650304917, MTO Protection Station Plus with Drape - Product Usage:... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65220955, MTO Left Heart Kit VA Med San Francisco - Product Usage:... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650600111, MTO Left Heart St Francis Hosp - PG - Product Usage: NA... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #65021652, MTO Left Heart Kit United Reg Health - Product Usage: NA... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 14, 2020 Kit Model #650301018, MTO Vascular Surgery - Cleveland Clinic PG - Product Us... Non-sterile kits intended to be sterilized prior to use were sold to accounts without sterilizati... Class II Medline Industries Inc
Sep 1, 2020 ClearPro Closed Suction Catheter, Model DYNCPDS14T, 14 Fr FOR ENDOTRACHEAL T... There have been reports of the suction catheter coming apart from the device assembly during use. Class II Medline Industries Inc
Aug 12, 2020 Central Line Dressing Change Tray Potential of incomplete seals impacting the sterility of the kit. Class II Medline Industries Inc
Jul 28, 2020 Control, Calibrator Verified, Triage BNP, Model ALR88755 Product was shipped with refrigeration (ice) instead of frozen (dry ice). Class II Medline Industries Inc
Jul 9, 2020 Endoscopic Cleaning Brush - Product Usage: Endoscopic cleaning brushes are si... Potential risk of brush detachment during cleaning. Class II Medline Industries Inc
Jun 30, 2020 ClearPro T-Piece Closed Suction Catheter, Model DYNCPTP14, 14 Fr 21.3 IN FOR ... There are reports of the suction catheter coming apart from the device assembly during use. Class II Medline Industries Inc
Jun 30, 2020 ClearPro Trach T-Piece Closed Suction Catheter, Model DYNCPTP14T, 14 Fr 12.5 ... There are reports of the suction catheter coming apart from the device assembly during use. Class II Medline Industries Inc
Mar 9, 2020 Custom convenience kits containing Medline brand Sterile Pre-Saturated Povido... Medline identified that there may be a potential for voids in the packaging seal and loss of ster... Class II Medline Industries Inc
Feb 10, 2020 Medline Winged Sponges Presaturated W/PVP REF DYND70289 DYND70289H Expiration... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
Feb 10, 2020 Medline Sterile 3mL Syringes with 21GA x 1 Inch Needle 80 each REF DYND3ML21G... Voids were discovered in the packaging seal and loss of sterility on the outside of the contents ... Class II Medline Industries Inc
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 7, 2020 Medline DYNDA1928 VP TRAY WITH PVP Packaged in Mexico GLOVE:Made in Malays... There is potential for the sterile wrap to become loose while in transit and compromise the steri... Class II Medline Industries Inc
Oct 30, 2019 Anesthesia Pediatric Circuit 72", Model DYNJAPF6057A The 10mm inner green inspiratory tubing is disconnected from the tee connector at the machine end... Class II Medline Industries Inc
Sep 18, 2019 EVENCARE G3 Blood Glucose Test Strips, 1 test strip per foil pouch, 50 foil p... Incomplete seal and premature expiration of individually packaged Blood Glucose Test Strips. Class II Medline Industries Inc
Sep 6, 2019 MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: ... The recall is being conducted due to a potential defective component on the circuit board causing... Class II Medline Industries Inc
Aug 9, 2019 Medline SYRINGE, PISTON,IRR TRAY,W/.9, REF DYNC2303. Sterile Piston Irrigati... Samples in the identified lot were found to have incomplete or open packaging seals. Class II Medline Industries Inc

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.