Browse Device Recalls
2,968 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,968 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 2,968 FDA device recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 30, 2024 | Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is ... | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow... | Class II | Dental EZ Group Star Dental Division |
| May 17, 2024 | Stimuplex A, 30 DEG, 20GX6", 0.90x150mm, Catalogue Number: 4894278 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 22GX2", 0.70x50mm, Catalogue Number: 4894502 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 21GX4", 0.80x100mm, Catalogue Number: 4894260 | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 17, 2024 | Stimuplex A, 30 DEG, 24GX1", 0.55x25mm, Catalogue Number: 4894251. | The devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used cont... | Class II | B Braun Medical Inc |
| May 13, 2024 | Aeos Robotic Digital Microscope, Product Code: PV010 | Possibility of the robotic arm to drop more than 10cm from its original position after pressing t... | Class II | Aesculap Inc |
| May 7, 2024 | CORI Starter Kit, Real Intelligence CORI, CORI STARTER KIT - UNIVERSAL.Intend... | CORI Surgical System with Real Intelligence Software exhibits an increased Marker Registration Er... | Class II | Blue Belt Technologies, Inc |
| Apr 25, 2024 | STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, l... | Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not eng... | Class II | Synthes (USA) Products LLC |
| Apr 24, 2024 | EasySuite 4K Integrated Operating Room System Model/Catalog Number: EasySuit... | A subset of the ES4K systems do not have complete records for earth leakage testing. The earth le... | Class II | Olympus Corporation of the Americas |
| Apr 18, 2024 | OES 4000 Hysteroscope, Model/Catalog Number: A4674A | The required leakage test was not performed following of a re-work for a non-conformity. This cou... | Class II | Olympus Corporation of the Americas |
| Apr 3, 2024 | InstaClear Lens Sheath. The InstaClear lens cleaner system and versatile shea... | Potential for distal end of the sheath to break off during a procedure. | Class II | Olympus Corporation of the Americas |
| Apr 1, 2024 | OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 11... | Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alar... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | BiPAP A30 Ventilator, Part Number 1111143 (US and OUS) OUS Only: Part Numbe... | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | BiPAP A40 Ventilators: BiPAP A40, Part Numbers 1111169 (US and OUS) and ... | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 26, 2024 | BiPAP V30 Auto Ventilator, Part Number 1111178 | Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative ... | Class I | Philips Respironics, Inc. |
| Mar 21, 2024 | Siemens Artis Models: Interventional Fluoroscopic X-Ray Systems-Models: Arti... | Coolant level in the cooling circuit drops below a certain level, this may result in a situation ... | Class II | Siemens Medical Solutions USA, Inc |
| Mar 20, 2024 | Dr¿ger Perseus A500 Anesthesia Workstation | Unexpected shutdown while operating on battery power. | Class I | Draeger Medical, Inc. |
| Mar 19, 2024 | Trilogy Evo, all software versions except 1.05.06.00. Ventilator for pediatri... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Garbin EVO, all software versions except 1.05.06.00. Ventilator for pediatric... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediat... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo O2, all software versions except 1.05.06.00. Ventilator for pedia... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Aeris EVO, all software versions except 1.05.06.00. Ventilator for pediatric ... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | LifeVentEVO2, all software versions except 1.05.06.00. Ventilator for pediatr... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 19, 2024 | Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ve... | Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while uni... | Class I | Philips Respironics, Inc. |
| Mar 7, 2024 | POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 7, 2024 | POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indica... | Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immedia... | Class II | Olympus Corporation of the Americas |
| Mar 4, 2024 | X-Guide Handpiece Adaptor Sleeve 1, Model P010701 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... | Class II | X-NAV Technologies, LLC |
| Mar 4, 2024 | X-Guide Handpiece Adaptor Sleeve 3, Model P010727 | The Handpiece Adaptor may have a manufacturing defect causing incorrect geometry. The incorrect g... | Class II | X-NAV Technologies, LLC |
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Mar 1, 2024 | Olympus Triangle Tip Electrosurgical Knives- to be used with Olympus endoscop... | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Si... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Feb 17, 2024 | Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Us... | A deterioration of the cutting knife, including overheating and burning, can contribute to tip br... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Premium SuperPulsed Laser (TFL-PLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 29, 2024 | SOLTIVE Pro SuperPulsed Laser (TFL-SLS ) | A non-compliant power cord may have been supplied in regions that do not utilize the Type B or Ty... | Class II | Olympus Corporation of the Americas |
| Jan 24, 2024 | TFNA Femoral Nail 11mm, right, 130¿, L 235mm-Intended for temporary fixation... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RIA Tube Assembly, minimum 520 mm length, sterile- intended for use in adult... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 2.5MM DRILL BIT/QC/GOLD/110MM STERILE-surgical, orthopedic, pneumatic powered... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | VA-LCP Clavicle Plate 2.7, shaft, CS1, right-Intended for fixation of clavicl... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 1.5MM Drill Bit/QC/85MM Sterile-surgical, orthopedic, pneumatic powered & acc... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | TFNA Femoral Nail 9mm, right, 130¿, L 235mm-Intended for temporary fixation ... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | 13 mm Titanium Hindfoot Arthrodesis Cannulated Nails EX, sterile -Intended to... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | RAPIDSORB IPS Battery Pack, Sterile-Intended for use in non-load bearing frac... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 24, 2024 | Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenera... | Products not sterilized, sterility cannot be confirmed | Class II | Synthes (USA) Products LLC |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, PERIFIX FX 19 Ga. S... | Kits should contain Filter Straws with Standard Luer Connections however the kits contain Filter ... | Class II | B. Braun Medical, Inc. |
| Jan 22, 2024 | Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy, 5 mL Glass Luer Loc... | Kits should contain Filter Straws with Standard Luer Connections however, the kits contain Filter... | Class II | B. Braun Medical, Inc. |
| Jan 16, 2024 | InstaClear Lens Cleaner-indicated for use during routine diagnostic procedure... | Japanese IFU version had slightly different language and illustrations from the English IFU, whic... | Class II | Olympus Corporation of the Americas |
| Jan 16, 2024 | Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be use... | Water filter may have been assembled incorrectly, resulting in unfiltered tap water being used fo... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190L. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
| Jan 11, 2024 | Colonoscope, Model Number PCF-H190TL. | Specific repaired colonovideoscopes were assembled without an adhesive which protects them from c... | Class II | Olympus Corporation of the Americas |
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.