Hazard Type

Sterility Issue Recalls

10,814 product recalls involving sterility issue. Search official CPSC, FDA, and USDA datasets for every recall issued due to this hazard.

10,814Total Recalls
297Critical
67933.1MUnits Affected
All Recalls

Every Sterility Issue Recall

Sorted by most recent. Click any recall for full details and safety information.

10,814 recalls
High RiskFDA
Family Pharmacy Of Statesville
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·1 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·1 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.
Ophthalmic Drugs·3 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.
Injectable Drugs·2 affected·Aug 6, 2020
High RiskFDA
Family Pharmacy Of Statesville
Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.
Drugs·4 affected·Aug 6, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 5/0 Undyed 30" KV-11, TaperCutting, Product Number: CV2293, UDI: 2088452115...
Medical Devices·1,264 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" CV-25 Taper, Product Number: CV3100, UDI: 20884521150901 - P...
Medical Devices·6,150 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-21 Taper CV946, UDI: 20884521151298 - Product Usage: indica...
Medical Devices·1,272 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" GS-25 CV604, UDI: 20884521152288 - Product Usage: indicated ...
Medical Devices·1,222 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" PC-11 SV487G, UDI: 10884521149595 - Product Usage: indicat...
Medical Devices·1,236 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" CV-25 Taper, Product Number: CV3110, UDI: 20884521150918 - P...
Medical Devices·8,598 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" KV-15 TaperCutting CV2279, UDI: 20884521151632 - Product Usa...
Medical Devices·1,244 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25, Product Number: CV605, UDI: 20884521152295 - Product Us...
Medical Devices·1,811 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 VL 18" P-10, Product Number: SV32, UDI: 20884521153117 - Product Usage:...
Medical Devices·1,270 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-11, Product Number: SVP2294, UDI: 20884521177403 - Product...
Medical Devices·1,886 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 2/0 Undyed 30" V-20 Taper, Product Number: CV417G, UDI: 20884521149370 - Pro...
Medical Devices·5,596 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-21 Taper, Product Number: CV947, UDI: 20884521153056 - Prod...
Medical Devices·3,103 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" V-20 Taper, Product Number: CV416G, UDI: 20884521149363 - Pr...
Medical Devices·3,107 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" SC-1, Product Number: SV2239, UDI: 20884521151779 - Product...
Medical Devices·1,248 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 1 Undyed 36" GS-25 CV605, UDI: 20884521152295 - Product Usage: indicated ...
Medical Devices·3,109 affected·Aug 3, 2020
High RiskFDA
Riverpoint Medical, Llc
Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-11 SVP2295, UDI: 20884521177410 - Product Usage: indicated...
Medical Devices·1,260 affected·Aug 3, 2020
High RiskFDA
Sorin Group Italia S.r.l.
Perceval Single Use Accessory Kit, Size S, REF: ICV1349, Sterile EO, Rx Only, CE, UDI: 8022057015211 - Product Usage: he Dual Collapser i...
Medical Implants·102 affected·Jul 29, 2020
High RiskFDA
Sorin Group Italia S.r.l.
Perceval Single Use Accessory Kit, Size M, REF: ICV1346, Sterile EO, Rx Only, CE, UDI: 8022057015228 - Product Usage: he Dual Collapser i...
Medical Implants·94 affected·Jul 29, 2020
High RiskFDA
Sorin Group Italia S.r.l.
Perceval Dual Collapser, Size S/M, REF: ICV1235, Sterile EO, Rx Only, CE, UDI: 08022057014832 - Product Usage: he Dual Collapser is a c...
Medical Implants·498 affected·Jul 29, 2020
High RiskFDA
Resource Recovery & Trading Llc
HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.28 Gal) plastic containers, Distributed by: Resource Recover...
Topical Drugs·115 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Fiberscope, Part: 11301BN1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examinatio...
Medical Devices·1,246 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible DCI Intubation Fiberscope, Part: 11302BDD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for exami...
Medical Devices·428 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Fiberscope, Part: 11301AA1, with Instruction Manual: Z18441US - Product Usage: are intended to be used for examinatio...
Medical Devices·91 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Fiberscope, Part: 11302BD2, with Instruction Manual: Z18445US - Product Usage: are intended to be used for examinatio...
Medical Devices·650 affected·Jul 27, 2020
High RiskFDA
Karl Storz Endoscopy
Flexible Intubation Video Endoscope, Part: 11303BNX, with Instruction Manual: Z20827US - Product Usage: are intended to be used for exami...
Medical Devices·380 affected·Jul 27, 2020
High RiskFDA
Globus Medical, Inc.
ALTERA Spacer ALTERA Spacer, 10x31, 8-12mm, 8¿ (sterile)
Medical Devices·0 affected·Jul 22, 2020
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 8.0 mm, REF NVTKIT-C8-5, Rx Only, Sterile UDIB006NVTKITC852/$$7062118C - Pro...
Respiratory Devices·1,239 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 2-Ch EMG ET Tube, 7.0mm, REF: LTE700DCM-5, Rx Only, Sterile EO UDI: B006LTE700DCM52 - Product Usage: For continuous EMG monito...
Respiratory Devices·3,425 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-CH EMG ET Tube, 6.0mm, REF: LTE700S-5, Rx Only, Sterile EO UDI: B006:TE700S52$$7050918B - Product Usage: For continuous EMG ...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Cobra x5 1-Ch EMG ET Tube, 7.0mm, REF LTE700M-5, Rx Only, Sterile EO CE UDI: B006LTE700M52/$$7061418C - Product Usage: For continuous EMG...
Respiratory Devices·0 affected·Jul 21, 2020
High RiskFDA
Neurovision Medical Products Inc
Nerveana x5 RLN Monitoring Kit with Cobra 1-Ch EMG ET Tube, 6.0mm REF NVTKIT-C6-5, Rx Only, Sterile, UDI: B006NVTKITC652/$$7061918A - Pro...
Respiratory Devices·1,089 affected·Jul 21, 2020
High RiskFDA
Pfizer Inc.
Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake F...
Drugs·19,144 affected·Jul 20, 2020
High RiskFDA
Qiagen Sciences Llc
QIAstat-Dx Respiratory SARS-CoV-2 Panel REF 691223 (US IVD under FDA EUA) - Product Usage: intended for the qualitative detection and dif...
Respiratory Devices·1,474 affected·Jul 15, 2020
CriticalFDA
Mylan Institutional Llc
Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103...
Injectable Drugs·18,480 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each,...
Drugs·988 affected·Jul 7, 2020
CriticalFDA
Carefusion 213, Llc
BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ...
Drugs·400 affected·Jul 7, 2020
High RiskFDA
Icu Medical, Inc.
APPX 0.75ml, 6-Port NanoClave Manifold (Glow, Red, Blue, Purple, Yellow Rings)BCV. 1 unit per pouch, 50 pouches per case. UDI: (01)10840...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18 cm) Appx 0.29 ml, Smallbore Ext Set w/MicroClave Clear, NanoClave, Clamp, Rotating Luer; 1 unit per pouch, 50 multivac pouches per...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7 IN (18CM) APPX 0.26ml, SMALLBORE EXT SET, MicroClave, Clave T-Connector.1 unit per pouch, 50 pouches per case. UDI: (01)10887709018065(...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
83" (211 cm) Smallbore Ext Set w/Remv 8 Gang 4-Way NanoClave¿ Stopcock w/Baseplate, Rotating Luer;1 unit per pouch, 25 pouches per case. ...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN (33cm) APPX 0.96 ml, PENTAFUSE SMALLBORE SET, NanoClave, 3 MicroClave Clear. 1 unit per pouch, 50 pouches per case. UDI:(01)1088770...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
13 IN(33cm) APPX 1.0 ml, SMALLBORE SET, 4 MicroClave Clear, NanoClave T-Conn, Filter; 1 unit per pouch, 50 pouches per case. UDI:(01)1088...
Surgical Devices·1 affected·Jul 6, 2020
High RiskFDA
Icu Medical, Inc.
7" (18cm) Appx 0.31 ml, Smallbore Ext Set w/Remv MicroClave¿ Clear, NanoClave T-Connector, Clamp, Rotating Luer. 1 unit per pouch, 50 mul...
Surgical Devices·1 affected·Jul 6, 2020